Position: Director/Senior Director, US Regulatory Lead – CMC Job 2431
Location: North Central NJ/Remote Work: Must live within a commutable distance from
company location to come in as needed.
Compensation: Based Upon Experience
Summary: The US Regulatory Lead – CMC has decision-making authority for all U.S. marketed product and regulatory CMC activities. Will direct the RACMC staff and shall develop and implement the regulatory strategy for the Company’s U.S. marketed products, as well as the CMC aspects of new products in development.
The US Regulatory Lead – CMC will assess, establish, and maintain the Company’s regulatory risk mitigation strategies. Incumbent shall assume primary ownership for the its overall regulatory CMC compliance, including the development, training, and monitoring of compliance with regulatory-related industry policies, regulations and procedures.
Essential Functions:
Assume ownership for Company’s U.S. Marketed Product regulatory activities, policies and procedures to ensure organizational compliance with U.S. regulatory directives, guidelines and laws pertaining to our business operations.
Assume ownership for company-wide regulatory CMC related activities, policies and procedures to ensure organizational compliance with all regulatory CMC related directives, guidelines and laws pertaining to our business operations.
Provide regulatory guidance for CMC aspects of new products in development from Phase l to commercialization.
Lead, develop and implement innovative and effective regulatory strategies consistent with company’s business goals and objectives.
Build high performance work teams by providing training and guidance to regulatory, quality and compliance personnel.
Allocate regulatory staff to the project teams to ensure consistent implementation of regulatory strategies for global development products and US marketed products throughout the lifecycle.
Lead liaison activities with the FDA; implement effective regulatory strategies for drug approval process and identify and negotiate resolution of CMC related issues and inquiries in an expeditious manner. Supervise all regulatory related submissions.
Participate in activities related to projects and products portfolio evaluation; assist in the selection of clinical candidates and medical indications and clinical development strategy and prioritization.
Work closely with SHQ and SEU to establish global CMC regulatory policies which include but are not limited to: life cycle management, handling Agency queries, review of regulatory documents for global submissions.
Manage PDUFA fees, and Establishment/Product Registration activities.
Other duties as assigned.
Requirements:
Advanced degree in scientific discipline required. Professional certification (s) preferred.
Minimum of ten (10) years of experience in a managerial / supervisory -level regulatory affairs and quality assurance role.
Established and effective working relationships with regulatory agencies, including the FDA and international regulatory agencies.
Working knowledge of clinical trial strategy, product development process, and statistical methods and data report preferred.
Attention to detail with proven effective research and analytical skills.
Excellent written and oral communication, technical writing, and editing skills.
Ability to articulate clearly and conduct verbal presentations with large and small audiences.
Strong interpersonal, communication and negotiating skills.
Demonstrated computer proficiency with MD Word, Excel, and Outlook.
Ability to effectively prioritize workload and tasks to effectively meet established deadlines.
Ability and willingness to travel domestically and internationally approximately 25% of the year via automobile, train and/or airplane.