What are the responsibilities and job description for the Regulatory Consultant position at Franklin Life Science?
Regulatory Consultant
Location: Hybrid (2-days per week in the Boston office) | Employment Type: Full-Time
About the Firm
Franklin Life Science is a life science consulting firm of fewer than ten people, providing regulatory, clinical, and strategic advisory services to biopharma and medical device companies ranging from early-stage startups to established sponsors. Our entrepreneurial focus means every team member works directly with clients and has real influence over engagement strategy and firm direction — there is no bureaucracy standing between good ideas and client impact.
Position Summary
We are seeking a Regulatory Consultant to join our growing team. This individual will serve as a trusted regulatory advisor to our clients, contributing hands-on execution alongside higher-level regulatory strategy — from early development planning through submission and post-approval activities. The ideal candidate brings a solid foundation of regulatory affairs experience (typically 7-10 years) and is ready to take on strategic responsibility with support from firm leadership, while also being comfortable managing day-to-day workstreams independently.
Key Responsibilities
- Serve as a day-to-day regulatory point of contact for a portfolio of client engagements, building strong, trusted working relationships.
- Develop and shape regulatory strategies across the product lifecycle, including development pathway selection, designation strategies (e.g., Fast Track, Breakthrough Therapy, Orphan Drug), and phase-appropriate regulatory planning.
- Prepare, review, and manage regulatory submissions and supporting documents (e.g., INDs/CTAs, meeting requests and briefing books, annual reports, amendments, NDA/BLA components) in collaboration with client teams.
- Support preparation for and participation in health authority interactions (e.g., FDA Type A/B/C/D meetings), including briefing document development and meeting strategy.
- Monitor and interpret evolving regulatory guidance, precedent, and requirements (e.g. FDA, EMA and other health authorities), and translate implications into practical client recommendations.
- Contribute to due diligence efforts, gap analyses, and regulatory risk assessments for client transactions and portfolio decisions.
- Collaborate cross-functionally with clinical, CMC, quality, and nonclinical colleagues (client-side and consultant-side) to ensure regulatory strategy is integrated with overall development planning.
- Help manage project timelines, deliverables, and client communications, escalating appropriately to senior consultants or firm principals.
- Support business development efforts, including proposal input and, over time, client relationship development, as the firm continues to grow.
- Mentor and provide guidance to more junior team members as the firm's team expands.
Qualifications
- Bachelor's degree required in a life sciences, pharmacy, or related scientific/technical discipline; advanced degree (MS, PhD, PharmD) and/or Regulatory Affairs Certification are a plus but not required.
- Approximately 7-10 years of regulatory affairs experience gained in industry, at a regulatory agency, and/or in a consulting environment, with direct exposure to regulatory strategy development (not solely submission execution).
- Demonstrated experience supporting at least one full development program from early phase through a significant regulatory milestone (e.g., IND clearance, End-of-Phase 2 meeting, NDA/BLA filing).
- Working knowledge of FDA regulations, guidance, and submission requirements; familiarity with ICH guidelines and international regulatory frameworks (e.g., EMA) is a plus.
- Strong written and verbal communication skills, with the ability to translate complex regulatory concepts for both scientific and non-scientific audiences.
- Demonstrated ability to manage multiple projects or competing priorities in a fast-paced, deadline-driven environment.
- Comfort working independently and proactively where individual ownership and flexibility are essential.
- Experience across a range of therapeutic areas and modalities preferred (small molecule, biologics, cell and gene therapy) — no single therapeutic area focus is required.
- Prior consulting experience is a plus, but not required for candidates with strong industry regulatory strategy experience.
What We Offer
- Direct, high-visibility client work from day one — no layers between you and the client or the strategic decisions being made.
- Mentorship from experienced regulatory and drug development leaders in a down-to-earth, low-bureaucracy environment.
- Competitive compensation, commensurate with experience, plus benefits.
- Meaningful opportunity to shape firm growth, processes, and culture as an early, valued member of a small team.
To Apply
Please submit a resume and brief cover letter describing your regulatory strategy experience and the types of programs/therapeutic areas you have supported.