Senior Regulatory Affairs Lead - NDA Strategy & Late-Stage

gloor & lang ag; Basel; In loco; CHF 150.000 - 195.000; Tempo pieno

Descrizione del lavoro

Innovative Biopharmaceutical Company in Northwestern Switzerland seeks a senior Regulatory Affairs professional with extensive NDA filing experience to lead internal capabilities. You will coordinate external partners, own critical RA activities, and ensure strategic oversight across development and submission programs.

As the late-stage program approaches pivotal readouts, you will collaborate with Clinical, CMC, Quality, Medical, and Safety teams, shaping regulatory pathways and maintaining

Competenze

• Bachelor’s degree in a life science field (Pharmacy/ Chemistry/ Pharmaceutical Sciences or equivalent).
• Approximately 10+ years in Regulatory Affairs within biotech/pharma development.
• Hands-on NDA filing experience with filing readiness and submission execution.
• Experience supporting late-stage development through first marketing authorization.
• Direct interaction with FDA/EMA or other health authorities.
• Strong CMC regulatory understanding and CTD Module 3 review capability.
• Experience with external regulatory experts and bringing knowledge in-house.
• Experience with small molecule development; infectious disease exposure is a plus.
• Fluent English with excellent communication and stakeholder-management skills.

Mansioni

• Develop and coordinate global regulatory strategy for late-stage development and pivotal milestones.
• Drive NDA planning, filing readiness, timelines, responsibilities, and review processes.
• Coordinate external consultants and submission partners while taking ownership of key RA activities.
• Plan and lead interactions with regulatory agencies (FDA/EMA) and other Health Authorities.
• Ensure regulatory alignment across clinical, nonclinical, and CMC activities and map development plans to regulatory pathways.
• Provide senior regulatory input for IND, IMPD, and CTA activities and align with marketing strategies.
• Build regulatory knowledge, documentation, and decision history; maintain SOPs and processes.
• Represent RA in multidisciplinary teams and collaborate with Clinical Development, CMC, Quality, Medical, Safety, and partners.
• Identify regulatory gaps and risks; provide pragmatic recommendations to senior management.

Conoscenze

Regulatory affairs leadership

NDA filing experience

Clinical development collaboration

FDA/EMA interaction

Strategic regulatory oversight

Cross-functional coordination

Excellent communication

English fluent

Formazione

Pharmacy/Chemistry/Pharmaceutical Sciences or Life Science

Descrizione del lavoro

Innovative Biopharmaceutical Company in Northwestern Switzerland seeks a senior Regulatory Affairs professional with extensive NDA filing experience to lead internal capabilities. You will coordinate external partners, own critical RA activities, and ensure strategic oversight across development and submission programs.

As the late-stage program approaches pivotal readouts, you will collaborate with Clinical, CMC, Quality, Medical, and Safety teams, shaping regulatory pathways and maintaining