Regulatory Consultant

Franklin Life Science; Boston (MA); Híbrido; USD 140.000 - 190.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Direct client work from day one

Mentorship from leaders

Competitive compensation

Opportunity to shape firm growth and文化

Descripción de la vacante

Franklin Life Science is a lean life science consulting firm in Boston seeking a Regulatory Consultant to advise clients and contribute hands-on regulatory execution alongside strategy development. You will work directly with clients on engagement strategy and regulatory plans across development stages.

The ideal candidate has 7–10 years of regulatory affairs experience across industry, agency, or consulting, with strong communication skills and a history of independent project ownership.

Formación

• Bachelor’s degree in life sciences or related field required; advanced degree or RAC a plus.
• 7–10 years of regulatory affairs experience across industry, agency, or consulting.
• Experience supporting at least one full development program from early phase to a major regulatory milestone.
• Working knowledge of FDA regulations, ICH guidelines, and international frameworks (EMA) is a plus.
• Strong written and verbal communication skills translating complex concepts for diverse audiences.
• Ability to manage multiple projects in a fast-paced, deadline-driven environment.
• Comfortable working independently with ownership and flexibility.
• Experience across therapeutic areas and modalities; consulting background a plus but not required.

Responsabilidades

• Serve as day-to-day regulatory point of contact for client engagements and build trusted relationships.
• Develop and shape regulatory strategies across product lifecycle and designations.
• Prepare, review, and manage regulatory submissions and supporting documents with client teams.
• Support preparation for health authority interactions, including briefing documents and meeting strategy.
• Monitor evolving regulatory guidance and translate implications into practical client recommendations.
• Contribute to due diligence, gap analyses, and regulatory risk assessments.
• Collaborate cross-functionally to ensure regulatory strategy aligns with development planning.
• Help manage project timelines, deliverables, and client communications; escalate when needed.
• Support business development efforts and client relationship growth over time.
• Mentor junior team members as the firm grows.

Conocimientos

Regulatory strategy

Regulatory submissions

Cross-functional collaboration

Project management

Regulatory communications

Independent work

Strategic thinking

Attention to detail

Educación

Bachelor's degree in life sciences or related field

Descripción del empleo

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.