Senior Regulatory Strategy Lead - Life Sciences (Remote)

Franklin Life Science; United States; Hybrid; USD 140,000 - 220,000; Full time

Benefits offered by this job

Direct client work

Competitive compensation

Growth opportunities

Benefits

Job summary

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.

Responsibilities

• 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.

Skills

Regulatory strategy

Client engagement

Cross-functional leadership

Project management

Excellent communication

Education

Bachelor's degree (life sciences or related)

MS/PhD/PharmD or RAC (advantage)

Job description

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.