Associate Director / Senior Regulatory Affairs CMC

gloor & lang Pharma and Biotech Recruiting; Basel; Vor Ort; CHF 130.000 - 180.000; Vollzeit

Zusammenfassung

Innovative Biopharmaceutical Company in Northwestern Switzerland is seeking an experienced Regulatory Affairs CMC professional to shape global regulatory strategy for innovative small molecule therapies.

You will lead CMC activities across clinical development through registration, preparing Module 3 documentation and coordinating submissions with FDA, EMA and other authorities, while collaborating with multiple functions to drive lifecycle planning and regulatory risk management.

Qualifikationen

• Several years of experience in Regulatory Affairs CMC within biotech or pharmaceutical development.
• Proven experience supporting clinical development programs through late-stage development and registration.
• Familiarity with IND/IMPD/CTA/NDA/MAA submissions and regulatory guidance.

Aufgaben

• Develop and execute global Regulatory Affairs CMC strategies across clinical development and registration programs.
• Lead and coordinate CMC regulatory activities from clinical development through marketing application.
• Prepare, review and drive high-quality Module 3 documentation for global regulatory submissions.
• Support and coordinate IND, IMPD, CTA, NDA and MAA submissions.
• Represent Regulatory Affairs CMC in multidisciplinary project teams.
• Provide strategic regulatory guidance throughout product development, technical changes and lifecycle planning.
• Prepare and support interactions with regulatory agencies including FDA, EMA and other Health Authorities.
• Collaborate with CMC Development, Pharmaceutical Development, Manufacturing, Analytical Development, Quality and external partners.
• Evaluate regulatory risks and contribute to overall development strategy.

Kenntnisse

Regulatory strategy

CMC expertise

Cross-functional leadership

Regulatory submissions

Ausbildung

Degree in Pharmacy

Life science degree

Tools

CTD Module 3

Regulatory databases

Jobbeschreibung

Innovative Biopharmaceutical Company | Northwestern Switzerland

Shape the Global Regulatory Strategy for Innovative Small Molecule Therapies

Our client is an innovative, research-driven biotechnology company advancing a portfolio of novel small molecule therapies through late-stage clinical development.

As the organization prepares for pivotal development milestones and future marketing applications, we are looking for an experienced Regulatory Affairs CMC professional who combines strategic thinking with hands-on regulatory expertise across clinical development and registration.

This position offers the opportunity to become a key member of the Regulatory organization and to play an important role in future regulatory leadership.

Your Responsibilities

• Develop and execute global Regulatory Affairs CMC strategies across clinical development and registration programs.


• Lead and coordinate CMC regulatory activities from clinical development through marketing application.


• Prepare, review and drive high-quality Module 3 documentation for global regulatory submissions.


• Support and coordinate IND, IMPD, CTA, NDA and MAA submissions.


• Represent Regulatory Affairs CMC in multidisciplinary project teams.


• Provide strategic regulatory guidance throughout product development, technical changes and lifecycle planning.


• Prepare and support interactions with regulatory agencies including FDA, EMA and other Health Authorities.


• Collaborate closely with CMC Development, Pharmaceutical Development, Manufacturing, Analytical Development, Quality and external development partners.


• Evaluate regulatory risks and contribute to overall development strategy.

Your Profile

• Degree in Pharmacy, Chemistry or another Life Science discipline.


• Several years of experience in Regulatory Affairs CMC within biotech or pharmaceutical development.


• Proven experience supporting clinical development programs through late-stage development and registration.


• Demonstrated experience with IND, IMPD, CTA, NDA and/or MAA submissions.


• Strong expertise in CTD Module 3.


• Experience interacting directly with regulatory agencies such as FDA and EMA.


• Solid background in small molecule development.


• Excellent communication skills with the ability to influence multidisciplinary project teams.

Preferred Experience

• Experience supporting first marketing applications.


• Experience in innovative biotech environments.


• Experience working with outsourced manufacturing organizations and external development partners.


• Scientific background combined with pragmatic regulatory thinking.


• Previous exposure to global development programs from Phase I through registration.

What You Can Expect

• A highly visible strategic role within an innovative biotechnology company.


• Direct involvement in global development and registration activities.


• Close collaboration with experienced scientific and regulatory leaders.


• Broad responsibility with significant influence on development strategy.