Principal Regulatory Consultant
Principal Regulatory Consultant
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Salary Not Disclosed
1 Vacancy
Job Description
Job Description
Are you an experienced regulatory professional ready to take the lead in shaping innovative CMC strategies Barrington James is recruiting for a Principal/Senior Consultant (CMC) to join a dynamic and growing global consultancy. This is a hybrid role based in Breda Netherlands with a flexible schedule and monthly office visits. If youre passionate about guiding clients through complex regulatory landscapes while mentoring the next generation of experts we want to hear from you!
*Minimum of 8 years experience required*
In this role youll provide strategic and technical regulatory advice to clients focusing on CMC (Chemistry Manufacturing and Controls) aspects of product development. Youll also oversee regulatory submissions guide multi-jurisdictional projects and manage client relationships. Additionally youll play a key role in mentoring junior team members and contributing to business development efforts.
Responsibilities
- Develop innovative CMC regulatory strategies gap analyses and drug development plans.
- Lead the preparation authoring and review of regulatory documents (INDs IMPDs MAAs etc.).
- Represent clients in regulatory agency interactions addressing objections and negotiating outcomes.
- Oversee project timelines budgets and deliverables ensuring high-quality outcomes.
- Mentor and manage team members providing training and technical leadership.
- Contribute to business development through client relationships and identifying new opportunities.
- Stay ahead of regulatory trends and ensure compliance with evolving standards.
Requirements
- Senior Consultant: 8 years in drug development and regulatory affairs.
- Principal Consultant: 10 years in drug development and regulatory affairs.
- Proven experience with FDA EMA and/or MHRA processes including submissions and negotiations.
- Expertise in biologics ATMPs vaccines or small molecules.
- Advanced degree in life sciences (MSc or PhD preferred).
- Strong leadership organizational and time management skills.
- Willingness to travel occasionally and work flexible hours.
To apply:
Direct line:
Required Experience:
Staff IC
Employment Type
Full-Time
