Senior Regulatory Consultant

Franklin Life Science; United States; Hybride; USD 140 000 - 220 000; Plein temps

Avantages offerts par ce poste

Direct client work

Competitive compensation

Growth opportunities

Benefits

Résumé du poste

Franklin Life Science is seeking a Senior Regulatory Consultant to partner with clients across the product lifecycle, from development planning to submissions and post‑approval activities. The role blends hands-on regulatory execution with strategic advisory, requiring strong communication and leadership.

You will manage multi‑client portfolios, shape regulatory strategy, and coordinate with cross‑functional teams. Boston-based or remote, full-time with competitive compensation and benefits.

Qualifications

• Bachelor's degree in a life sciences, pharmacy, or related field.
• Approximately 12+ years of regulatory affairs experience in industry, agency, or consulting.
• Experience supporting IND clearance, End‑of‑Phase 2 meetings, NDA/BLA filings.
• Strong written and verbal communication, ability to translate regulatory concepts.
• Ability to manage multiple projects in a fast-paced environment.
• Experience across multiple therapeutic areas and modalities preferred.
• Prior consulting experience is a plus but not required.

Responsabilités

• Serve as day-to-day regulatory point of contact for client engagements.
• Develop and shape regulatory strategies across the product lifecycle.
• Prepare, review, and manage regulatory submissions with client teams.
• Lead health authority interactions and briefing document development.
• Monitor evolving regulatory guidance and translate into client recommendations.
• Manage due diligence, gap analyses, and regulatory risk assessments.
• Collaborate cross-functionally to align regulatory with development planning.
• Manage project timelines, deliverables, and client communications.
• Generate new business.

Connaissances

Regulatory strategy

Client engagement

Cross-functional leadership

Project management

Excellent communication

Formation

Bachelor's degree (life sciences or related)

MS/PhD/PharmD or RAC (advantage)

Description du poste

Location: Boston based or Remote | Employment Type: Full-Time

About the Firm

Franklin Life Science is a life science consulting firm providing regulatory, clinical, and strategic advisory services to biopharma and medical device companies ranging from early-stage startups to established biopharma companies. Our entrepreneurial focus means every team member works directly with clients and has real influence over engagement strategy, client work and our firm’s direction — there is no bureaucracy standing between good ideas and client impact.

Position Summary

We are seeking a Senior 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 regulatory affairs expertise (typically 12 or more years) and is capable to handle strategic responsibility with support from firm leadership, while also managing day‑to‑day workstreams for themselves and client teams.

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.
• Prepare for and lead 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.
• Manage 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.
• Manage project timelines, deliverables, and client communications, escalating appropriately to senior consultants or firm principals.
• Generate new business.

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 12+ years of regulatory affairs experience gained in industry, at a regulatory agency, and/or in a consulting environment, with experience developing regulatory or program strategies (not solely submission execution).
• Demonstrated experience supporting programs through IND clearance, End‑of‑Phase 2 meeting, NDA/BLA filing and/or other significant milestones
• 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 with clients, collaborators and additional stakeholders 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.
• Opportunities to develop and drive the business (engagement types and therapeutic areas) that allow you to make high value impact to clients and human health
• 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.