Director, Regulatory Affairs

Job Description:

Reporting to the VP, Regulatory Affairs, the Director of Regulatory Affairs will lead and participate in regulatory activities associated with IND/CTA/NDA/MAA development and maintenance for support of new and ongoing clinical trials. The Director, Regulatory Affairs supports regulatory strategy and regulatory submissions, ensuring compliance with regulatory requirements. This role will involve day-to-day tasks such as overseeing regulatory activities, coordinating with internal and external stakeholders, and staying updated on relevant regulations and industry trends. This role requires an independent, self-directed, and highly motivated clinical regulatory professional.

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Job Responsibilities

Essential Job Functions and Responsibilities may include but are not limited to:

• Provide regulatory leadership and participate in regulatory activities associated with new product development and maintenance for support of new and ongoing clinical trials.
• Represent regulatory on clinical study and clinical development program teams throughout study conduct and product development.
• Tracks global regulatory submissions and Health Authority approvals for clinical study teams
• Review relevant clinical documents (protocol, informed consent form, investigator’s brochure, and site documentation, and required regulatory forms) for regulatory compliance.
• Plan, author, and execute and/or review regulatory documents required for product development (e.g. New IND/CTAs, DSUR, Meeting Requests/Briefing Packages, iPSP/PIP, NDA/MAA).
• Lead development of global regulatory submissions, including responses to health authority requests for information, safety reports, clinical protocol amendments and other submissions as required.
• Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation
• Provide oversight of regulatory submissions to ensure technical accuracy, compliance, and completeness.
• Maintain regulatory databases, including submission and correspondence logs
• Provide regulatory support for company compliance initiatives, including SOP development, Veeva and documentation initiatives and inspection preparedness.
• Keep current on US and OUS regulations that apply to company products and processes.
• In-depth understanding of regulations and guidelines governing all phases (pre-IND through post-approval) of drug development and working knowledge of US regulations and practices pertaining to the development, manufacture, testing and distribution of pharmaceutical products.
• Monitors compliance with regulatory requirements and commitments.
• Other duties as assigned.

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Required

EXPERIENCE: 

• BS in a relevant scientific discipline with a minimum of 10 years in the biopharmaceutical industry 7+ years of experience in pharmaceutical or biotech regulatory affairs including clinical regulatory affairs for oncology products.
• Independent, self-directed, and highly motivated clinical regulatory professional.
• Ability to translate regulatory requirements into practical workable plans
• Experience working in small and mid-sized biopharmaceutical companies is highly desirable.
• Diverse experience with regulatory activities including creation of systems and processes to support efficient and high-quality submission of documents to regulatory bodies.
• Strong organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail.
• Ability to build strong relationships with co-workers and vendors of various backgrounds and expertise.
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment.
• Effective interpersonal and communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.

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Preferred

Advanced scientific degree (PharmD/ MS/ PhD) with 15+ yrs experience in regulatory affairs.

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PHYSICAL DEMANDS AND WORK ENVIRONMENT:

Typical office environment. Prolonged periods of sitting at a desk and working on a computer. Must be able to lift 15 lbs. at times.