Position: Regulatory Affairs Site Head & Director Job # 2111
Location: Spokane, WA
Compensation: Based Upon Experience
The Regulatory Affairs Site Head & Director 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. Responsibilities extend to business sites in Washington State and Canada.
Duties and responsibilities include but are not limited to:
Providing management and leadership to the Regulatory Affairs department in the development and implementation of regulatory strategies and processes to gain and maintain product approvals worldwide.
Responsible for the preparation and filing of all regulatory documents with FDA and international regulatory agencies, as well as, for support of client applications.
Providing council, training and interpretation of regulations (FDA, State, ISO, CE, etc.) to ensure the proper policies and procedures are in place to obtain regulatory approvals and maintain regulatory compliance.
Managing relationships with relevant regulatory agencies, officials, key opinion leaders and medical doctors to improve quality of submissions and understand the impact of pending or proposed regulatory changes on the company.
Providing strategic and tactical direction for all Regulatory Affairs activities, including active participation in problem solving analysis by assessing and proposing alternative solutions to CMC issues and prepare contingency plans while still meeting regulations.
Directing the compliance with both federal and state laws and regulations governing the design, manufacture and distribution of drugs, biologics and medical devices specifically for manufacturing and global distribution centers. This includes, but is not limited to: FDA, Health Canada, State and Federal regulations and statutes.
Responsible for assisting in analyzing public policy developments and drafting responses on legislative and regulatory initiatives.
Accountable for planning and preparing pharmacovigilance reports for review of Medical Expert and submission to the appropriate regulatory agency.
Providing strategic regulatory advice on promotional issues to ensure that product promotions are consistent with policies, PhRMA guidelines, State Laws and applicable FDA regulations and standards.
Developing and advancing action plans to achieve targets and drive performance; as well as, development of staff for functional effectiveness and ensuring budgets and schedules meet corporate requirements
Bachelor Degree is required, science or healthcare preferred.
Masters with an Emphasis in Regulatory, Business or Scientific Discipline is desired.
10 years of direct experience is required with Masters or Doctorates.15 years with a Bachelors.
Minimum of 7 years supervisor/managerial experience.
Pharmaceutical experience is required with biologics experience; Medical Device experience preferred.
FDA Regulated Industry experience required with a minimum of 15 years in a pharmaceutical, medical device or healthcare industry.
Regulatory CMC experience with strong project management skills required; Allergenic or immunology experience preferred.
Relevant filing experience required with proven experience managing BLA submissions to approval; Medical device 510(k) experience is desired.
Experience leading negotiations and Health Authority interactions with FDA, Health Canada, EMA, TGA, etc. required.
Proficiency using Microsoft Word and Excel required. Experience using Microsoft PowerPoint, Microsoft Access, ERP/MRP system (SAP preferred), and/or Complaint Handling Database (ARGUS preferred).
Advanced in-depth technical knowledge and solid understanding of relevant FDA and USDA federal, state and local regulations as well as ISO standards.
Able to negotiate resolution to challenges impacting Regulatory compliance and assist in creating rationale strategies to guide the organization
Requires an understanding eCTD requirements and experience in writing, preparing and submitting relevant CMC documentation.
Some overnight travel required.