Introduction to Ruderfer & Associates, Inc.
Ruderfer & Associates is an executive search firm headquartered in Verona, New Jersey. With over forty years of search experience we are able to source all disciplines within the Pharmaceutical, Medical Device, Allied Healthcare and Consumer Products industries including: executive management, physicians (clinical research, clinical development, medical affairs and pharmacovigilance), regulatory affairs and legal, research & development, project management, marketing (marketing, payer marketing and market research), licensing/business development/acquisitions, human resources, quality assurance and quality control, manufacturing, finance and sales management. All of our recruiters are alumni of the biopharmaceutical industry and are experienced and sensitive to your needs. It is our philosophy to treat all candidates as we would have wanted to be treated when we were on your side of the desk. Thus, while we maintain a database of over 50,000 candidates - a rich resource to start a search - we will never present a resume to any company without the explicit approval of the candidate. In addition, any recommendations or referrals are kept completely confidential unless we are directed otherwise. This is important to you the candidate and to our clients.
In summary, Ruderfer & Associates’ ongoing relationship with the companies and candidates we represent has cemented a well-founded reputation of excellence based on mature decision-making and professional integrity. We look forward to meeting and working with you.
Our Current Opportunities
Regulatory Affairs/ Quality Assurance
NEW – Regulatory Affairs, Site Head & Director – #2111– Spokane, WA – Leads the development, implementation, and direction of effective regulatory strategies with oversight for all regulatory functions pertaining to the pharmaceutical, biologics and/or device programs supporting the established business units. This position provides leadership to ensure site expectations are met by providing regulatory vision, strategy and planning relevant to CMC (premarket & post-approval activities), compliance and policy as it pertains to federal/state laws and regulations. Requires bachelor’s degree in science or healthcare; master’s degree in regulatory, business or scientific discipline preferred. Must have pharma biologics experience and FDA regulated industry experience.
NEW – Regulatory Affairs, Senior Director/Executive Director – #2102 – Westchester, NY – This management position in Regulatory Affairs involves the ability to lead and manage the regulatory affairs organization so that all corporate objectives are met within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements. In addition, the position assists corporate senior management in understanding Regulatory strategies/processes while developing corporate objectives and, importantly, understanding the impact of decisions across therapeutic areas. Requires advanced degree in science related discipline; minimum 15 years of pharma experience.
NEW – Regulatory Affairs, Executive Director - Cardiovascular – #2085 – Westchester, NY – Provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for the company’s clinical asset candidates.
NEW – Global Regulatory Labeling, Director – #2084 – Northern CA – The Director of REG-GL provides regulatory labeling leadership to the labeling team and cross functional teams where Reg labeling membership is required. Manage the strategic regulatory labeling health authority interactions labeling negotiations worldwide. The Director is responsible for ensuring the execution of global regulatory labeling are aligned with the global regulatory strategy and corporate goals. Oversees and mentors labeling professionals to achieve regulatory objectives. A minimum of 12 years of pharmaceutical or health authority industry experience and at least 4-6 years experience in global labeling required.
NEW – Global Regulatory Labeling, Associate Director – #2083 – Northern CA – The Associate Director of REG-GL provides strategic and operational regulatory labeling input to labeling content, submission, production, and implementation worldwide. The Associate Director works in close collaboration with subject matter experts on the Product Labeling Teams (PLT), Global Regulatory sub-teams, and Senior Management Review Teams to ensure the execution of global regulatory labeling plans are aligned with the global regulatory strategy and with our client’s labeling processes and standards. A minimum of 8 years of pharmaceutical or health authority industry experience and at least 3 years experience in global labeling required.
NEW – Regulatory Affairs, Director/Associate Director – CMC EU - #2082 – Central NJ – The Director/Associate Director serves as the EU Regulatory Affairs (RA) CMC member for all assigned developmental projects and for life-cycle management of approved product in the European Union. This position executes the EU regulatory strategy and provides regulatory support and guidance to the RA CMC members supporting development projects and life cycle management based upon EU regulatory experience and knowledge of EMA and national guidances. Must have: Master’s degree in scientific discipline; 8-10 years of relevant pharmaceutical experience plus 4 years of direct EU CMC regulatory experience for Associate Director / 10-12 years of relevant pharmaceutical experience plus a minimum of 5 years of direct EU CMC regulatory experience for Director.
NEW – Regulatory Affairs, Senior Manager/Associate Director – Biologic CMC – #2076 – Northern NJ; Raleigh NC; or Philadelphia, PA – The Senior Manager/Associate Director, CMC Regulatory Affairs provides regulatory expertise on specific projects/queries relating to CMC for biologic products (primarily monoclonal antibodies (mAbs) in development from a global perspective and strengthen the science and scientific arguments made in the Quality section of all submissions (IMPDs/INDs, briefing documents for scientific advice, BLAs/MAAs, variations etc.) made by the company. Must have: Bachelor’s degree in science or technical discipline (advanced degree MSc., PhD, or MBA preferred); 4-6 years of relevant pharmaceutical experience plus 2-3 years of CMC biologic support for Sr. Manager / 6-8 years of relevant pharmaceutical experience plus 4-6 years of CMC biologic support for Associate Director.
NEW – Regulatory Affairs Labeling Strategist, Manager or Senior Associate – #2071 – Northern NJ – Under direction from managers, this position will undertake the responsibility for preparation, review and approval of labeling to support US pre-approval and commercial efforts. The incumbent will serve as a liaison to the US FDA, internal the company’s cross-functional teams and external third party entities. The incumbent will work closely with the Regulatory Affairs teams to ensure timely and comprehensive support to meet business unit timelines for all submissions containing labeling components. Bachelor’s degree required; must have pharmaceutical regulatory experience with substantial labeling review experience.
NEW – Clinical Quality Control , Director #2068 – Northern NJ – New position, lead all Oncology Business Unit Quality Management for all Clinical processes (operations) in US and Europe including Clinical SOPs, Systems, data integrity, etc. Reports to a Corporate Officer and will lead a small team. Oncology experience is strongly preferred.
NEW – Project Leader, Regulatory Affairs – # 2066 – Remote/NJ – The Project Lead, Regulatory Affairs is responsible for leading and executing all regulatory strategy and filings. In addition, this position will also provide regulatory support and guidance to cross-functional teams and ensure all applicable global regulatory requirements are considered and appropriately incorporated into clinical and commercial products. Must have: BS in Life Sciences or Chemistry; 7+ years of pharmaceutical experience with 5+ years of hands-on regulatory affairs project lead experience.
NEW – Quality Affairs, Manager – #2065– Fort Worth, TX - Develops and coordinates the execution of “customer-centric” quality and regulatory programs, prior QA experience required. Sterile products/medical device Quality/Regulatory experience strongly preferred.
NEW – Quality Affairs, Director – #2064 – Fort Worth, TX – Lead and manage all QA for established, Medical Devices provider. Must have sterile products experience (Gamma and EtO sterilization as well as sterile packaging); a minimum of 5 years QA leadership experience in medical device environment; knowledge of ISO 13485 and CFR Part 820; proven communication experience with FDA; and 3+ years of supervisory experience.
NEW – Director of Advertising & Promotion – #2060 – Westchester, NY - Review, approve and monitor product advertising and promotional labeling pieces for compliance with regulatory agencies’ requirements. Provide regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies for assigned products. Must have: Bachelor’s degree in science or health related discipline (advanced degree PhD, MD, MS, or PharmD preferred); 8+ years of relevant pharmaceutical experience with 4-6+ years of relevant pharmaceutical advertising and promotion experience; knowledge of the pharmaceutical industry regulatory affairs discipline for prescription drugs.
NEW – Associate Director, Quality & Compliance PV – #2062 – Westchester, NY – This position is responsible for managing staff and activities related to ICSR case quality reviews, ongoing monitoring of departmental compliance, and trending of quality and compliance metric to identify process improvements and advise the head of PV. This role will also provide support to department's effort in maintaining preparedness audits and health authority inspections. This is a supervisory role with individual contributor responsibilities.Maintain an accurate and timely system for monitoring / managing compliance with all case reporting requirements (eg, with health authorities, license partners, contract research organizations). Must have: Experience in a pharmaceutical industry with at least 2 years of people management experience and 10 years of industry experience----Minimum of Bachelors Degree Required.
Director, Regulatory Affairs, Oncology – #2051 – Northern NJ – This position independently leads the preparation, alignment and formulation of a global regulatory submission strategy with direct accountability for US and/or Europe.
Senior Director of Regulatory Affairs, Neurosciences – #2031 – Westchester, NY – Provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for the client’s clinical asset candidates.
Director of Labeling – #2020 – Southern NY – Manages the development, review, approval, and maintenance of labeling for designated products. Leads the Cross Functional Labeling Team and manages labeling projects for CCDS, USPI, EU SmPC, and local labeling effectively, and independently. Maintains and appropriately archives submitted and approved labeling documents and packaging component labeling. Participates in the development of the labeling objectives early in product development to assist teams in creating development strategies to achieve these objectives. Assist in the creation or revision of the labeling SOP or work instructions.
Executive Director of Regulatory Affairs Immunology & Inflammation – #2030 – Westchester, NY – Provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for the company’s clinical asset candidates.
Regulatory Affairs Advertising & Promotions Associate Director – #2013 – Central NJ – The Associate Director of Advertising & Promotion reviews, approves and monitors product advertising and promotional labeling pieces for compliance with regulatory agencies requirements.
Director, Regulatory Strategy Oncology – #1905 - Central NJ - This position independently leads the preparation, alignment and formulation of a global regulatory submission strategy with direct accountability for US and/or Europe. The role acts as point of contact for interactions with Health Authorities (HA) and global cross-functional team members and may lead team(s) when conducting FDA and/or EMA interactions. They will provide regulatory advice on internal or partnered development assets. Additionally, this position interacts with RA team members both regionally and globally, cross-functional team members, FDA Project Managers and/or Reviewers, and may interact directly or indirectly with ex-US Health Authorities.
Medical Affairs /Medical /Clinical Research, R&D, Project Management
NEW – Pharmacovigilance, Senior Director/VP – #2110 – Northern NJ – Reporting to the Chief Medical Officer (CMO), the VP/Senior Director, Pharmacovigilance, will be a clinically trained physician with accountability for overseeing the medical safety of the Company’s products, working cross-functionally for product safety and benefit-risk management and be able to manage outsourced vendors. This position will represent the company with health authorities for medical safety. In addition, the position will recommend the safety database of record based on review of proven vendors. US-trained Physician (MD or equivalent) with Board Certification; Minimum of 6 years in the pharmaceutical industry with a minimum of 4 years in pharmacovigilance.
NEW – Senior/Executive Medical Director, Clinical Research (Sleep) – #2106 – Northern NJ – The Senior Medical Director/Executive Medical Director, Clinical Research will provide direct support as a Subject Matter Expert to various compounds & programs related to the Sleep Disorders therapeutic area. Dependent upon specific projects or compounds, the incumbent may function as an International Project Team Leader. It is essential that qualified individuals possess Medical Doctor credentials. MD required, Board Certification in a related area preferred. Sr. Medical Director requires: 10+ years in pharmaceutical clinical development/ Executive Medical Director requires: 12+ years in pharmaceutical clinical development with experience directing Neurology Phase 2-3 global multicenter studies.
NEW – Senior Director, Clinical Research – Oncology – #2105 – Northern NJ – The Senior Director, Clinical Research - Oncology will be a key senior position in the Clinical Development group. The position carries operational and strategic level responsibilities for providing the clinical development, scientific and medical input, oversight and leadership for the company’s Oncology clinical development programs, with a focus on Early stage clinical development. Strategic accountabilities may include program leadership at IPT level, IPT lead role, design and execution of clinical development plans for oncology products from preclinical research. MD Required, Oncology Board Certified or Board Eligible, US or equivalent non-US preferred.
NEW – Associate Director, Clinical Research – Neuroscience – #2103 – Northern NJ – The Associate Director, Clinical Research is a newly created role for a dynamic individual with an PhD with experience in the pharmaceutical industry. The position is intended to provide the organization with as individual to oversee the conduct of clinical studies for Phase 2 and 3 development of compounds targeting dementia and, in particular, Alzheimer’s Disease. Additionally, this individual will contribute to the organization by analyzing and communicating results for these studies and by providing input into clinical development strategies as well as by performing medical monitoring for these and, possibly, other studies within the Neuroscience Business Group. PhD required with 4+ years in clinical research in the pharmaceutical industry, preferably with experience in Neuroscience and especially Dementia (e.g., Alzheimer’s disease).
NEW –Pharmacovigilance Operations, Director/Sr. Director – #2095 – NYC – This position handles operations side for a publicly listed biotech company in NYC.
NEW – Epidemiology – Cardiovascular, Director – #2092 – Westchester NY – The Director of Cardiovascular Epidemiology will assume the lead role in epidemiology activities in support of marketed and development compounds of cardiovascular therapeutic area (TA). You will be accountable for pharmacoepidemiology strategy, leading cross-functional project teams and epidemiology activities such as regulatory agency-required epidemiologic studies and generation of epidemiology data to support clinical development and regulatory filings and approval, and providing consultation as an in-house subject matter expert in epidemiology to other departments. MD degree in epidemiology required; 8+ years of experience including 5 years of industry/regulatory experience.
NEW – Epidemiology, Director – #2091– Westchester, NY – The Director will be accountable for epidemiology strategy and pharmacoepi projects for assigned marketed and/or development compounds as the therapeutic lead, leading epidemiology activities and cross-functional project teams to support clinical development and regulatory required non-interventional studies, and providing consultation as an in-house subject matter expert in epidemiology to other departments. Must have MD degree in epidemiology; 5+ years of post-doctoral experience, including 3 years of industry/regulatory experience.
NEW – Senior Director Pharmacovigilance Operations – #2086 – Central NJ – This position oversees case processing activities, staffing, processes, and interdepartmental projects involving PV case processing. This position collaborates within CSPV, global teams, sites and interdepartmental teams and interacts with CROs, vendors, and partners.
NEW – Clinical Development, Medical Director – #2074 – Northern NJ – The Medical Director will be responsible for providing medical and scientific direction and support to specific company clinical programs in line with its core business. This position will interact with competent authorities including the FDA, and lead filings for new drugs and/or indications from a medical perspective in collaboration with other functions - including Regulatory Affairs. The Medical Director may assume the role of Clinical Development Lead and/or Medical Monitor for a compound.
NEW – Executive Director Pharmacovigilance – #2073 – NYC – The company is seeking an MD who is a seasoned Pharmacovigilance specialist who knows how to submit the necessary documents to the various regulatory agencies but also how to interpret and advice senior management. The candidate should have strategic and technical expertise with excellent written and verbal communication skills (to communicate to non-technical senior management) that thrives in a creative, collaborative and engaging environment.
NEW – Risk Management, Director – #2063 – Westchester, NY – Reporting to Head of Risk Management, will be responsible for RM Lead activities for numerous and complex compounds. Take initiative/assume lead role in across-compound RM activities. Serve as in-house expert on designated RM topics. May assume personnel management responsibilities. Must have MD degree and 2+ years of drug safety experience including significant experience with PSURs/ DSURs/ (d)RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content).
Executive Director, Clinical Research – Alzheimer’s – #2015 – Northern NJ - The Executive Director, Clinical Research will provide direct support as a Subject Matter Expert to various compounds & programs related to the Alzheimer's Disease therapeutic area. Dependent upon specific projects or compounds, the incumbent may function as a International Project Team Leader. It is essential that qualified individuals possess Medical Doctor credentials.
Marketing/Business Development/Alliance Management
NEW – Head of Commercial - Generics – # 2108 – Central NJ – Reporting to the CEO/President, the Head of Commercial will lead all Commercial activities including Marketing, Sales, all Operations related to Sales and Marketing as well as all BD. Institutional Sales and marketing of injectables is strongly preferred. Bachelor’s degree required, MBA preferred. Must have at least 15 years of generic pharma experience.
NEW – Director Strategic Accounts – #2069 – Virtual – The ability to work in a team-oriented environment is essential in order to position highly strategic sales to our manufacturer and agency clients. Presentation and communication skills are essential to be successful in this role. Must have a minimum of 8 to 10 years advertising sales experience in pharmaceuticals.
NEW – Director, Business Development – #2067 – Central NJ – Lead all BD efforts for a Generic company focused on new compounds and 505B2 products. Must have prior generic experience including in and out licensing, M&A, and work with Investment Banking community.
NEW – Senior Manager, Medical Writing - Neuroscience – #2093 – Northern NJ – The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Neuroscience Programs. As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds’ life cycle management, with support from management as needed. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Bachelor’s degree required; minimum 5 years of CNS medical writing experience with compounds targeted for epilepsy preferred.
NEW – Associate Director, Medical Writing - Oncology – #2090 – Northern NJ – The ideal candidate will be the designated Lead Medical Writer for one or more oncology programs, responsible for supporting the critical regulatory medical writing needs, and offering direction to other staff/contractors regarding these projects. As the lead writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management. Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the compound to ensure alignment and consistency across studies. The qualified candidate will have proven ability to write and effectively manage the document preparation when necessary. Bachelor’s degree in life sciences required.
NEW – Chief Financial Officer (Business Partner) – # 2107 – Fort Worth Area, TX – A Texas based, rapidly expanding Medical Device company has asked us to conduct a confidential search to find a CFO. The CEO is looking for a “Business Partner,” the number 2 person in the company, to help manage the business. He is looking for a proactive leader. The company has about 125 employees and will be expanding to 160-170 in the next 12-18 months based upon increased volume. The client is in the process of implementing a closed loop manufacturing system, so strong system implementation experience is a plus. Compensation will be based upon experience along with a very lucrative equity package. The client will assist with relocation.