Regulatory Strategy Lead — Direct Client Impact, Hybrid

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

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.