Regulatory Affairs Strategist, US/EU Strategy (Hybrid)

Morgan Prestwich - Global Biotech, MedTech & CDMO Recruitment; Cambridge; Híbrido; GBP 70.000 - 110.000; Jornada completa

Descripción de la vacante

Morgan Prestwich - Global Biotech, MedTech & CDMO Recruitment is seeking a Regulatory Affairs Strategist/Lead to shape and drive US and European regulatory strategy for clinical-stage programs in selected indications.

The role translates scientific and development plans into regulatory pathways, provides hands-on leadership, and partners with cross-functional teams to ensure regulatory requirements are embedded from early development through pivotal studies and marketing authorization

Formación

• 5–10 years in regulatory affairs in biotech/pharma with clinical development up to Phase 3.
• Experience creating regulatory strategies for US and Europe.
• Experience with health authority interactions and CTD familiarity.

Responsabilidades

• Develop and execute US and European regulatory strategy for clinical-stage programs.
• Own regulatory project management and day-to-day delivery.
• Lead preparation and lifecycle management of regulatory submissions (FDA/EMA).
• Provide dossier strategy and content planning (CTD).
• Coordinate with authors and vendors to ensure timely submissions.
• Plan and execute health authority meetings (Scientific Advice, pre-IND, End of Phase 2).
• Advise on regulatory implications of development decisions.

Conocimientos

Regulatory strategy

Cross-functional leadership

Regulatory submissions

Educación

MSc, PhD, PharmD or MD in life sciences

Descripción del empleo

Morgan Prestwich - Global Biotech, MedTech & CDMO Recruitment is seeking a Regulatory Affairs Strategist/Lead to shape and drive US and European regulatory strategy for clinical-stage programs in selected indications.

The role translates scientific and development plans into regulatory pathways, provides hands-on leadership, and partners with cross-functional teams to ensure regulatory requirements are embedded from early development through pivotal studies and marketing authorization