Job ID: 7649
Job Title: Senior Regulatory Affairs Strategy & Policy Consultant
Location: Remote, United States
Location: Remote
Duration: 6–12 months, with potential for extension
Reports To: Senior Vice President, Head of Early Development
Position Summary:
We are seeking a highly experienced Senior Regulatory Strategy & Regulatory Policy Consultant with deep expertise in oncology and small-molecule drug development. The ideal candidate will have a strong track record of successful interactions with the FDA, including pre-IND meetings, IND submissions, and the development of regulatory strategies throughout the product lifecycle. This individual will also serve as a thought leader on regulatory policy and intelligence, providing strategic input to cross-functional teams.
Key Responsibilities:
- Lead and execute regulatory strategy for oncology programs involving small-molecule therapeutics, from preclinical through development phases.
- Prepare, review, and submit high-quality regulatory documents (e.g., INDs, briefing books, meeting requests, amendments).
- Support cross-functional teams (Regulatory Affairs, Clinical, Legal, Government Affairs) in aligning business objectives with regulatory policy landscapes.
- Analyze international (ICH) and country-specific guidelines, national regulations, and clinical trial/marketing application procedures, and translate complex scientific/technical information into concise written documents and presentations.
- Monitor and interpret global regulatory policy developments (e.g., FDA, EMA, ICH, WHO) relevant to Oncology product development.
- Act as the primary liaison with FDA and other regulatory authorities; manage and participate in formal regulatory meetings.
- Provide expert guidance on current regulatory policies, including the interpretation of FDA guidance and industry trends that impact the development of oncology drugs.
- Support cross-functional teams (Clinical, CMC, Safety, Commercial) to ensure regulatory alignment with overall development objectives.
- Monitor changes in the regulatory landscape and ensure compliance with applicable regulations and guidance.
- Assist in the development of internal regulatory procedures and best practices.
- Provide mentorship to junior regulatory staff or clients as needed.
Qualifications:
- An advanced degree (PhD, PharmD, MS, or equivalent) in a life science discipline is preferred.
- Minimum of 10 years of experience in Regulatory Affairs, with a focus on oncology and small-molecule drug development.
Extensive experience engaging in industry advocacy through participation in trade associations, regulatory working groups, and public comment processes. - Proven problem-solving mindset with the ability to think strategically and creatively to address complex regulatory challenges and advance development goals.
- Demonstrated success in leading FDA submissions and regulatory agency interactions, including face-to-face and teleconference meetings.
- Deep knowledge of FDA regulations, guidance documents, and regulatory policy relevant to oncology drug development.
- Experience with global regulatory requirements (e.g., EMA, Health Canada) is a plus.
- Strong project management, communication, and leadership skills.
