Plant Technical Manager at Lear Corporation overseeing engineering and maintenance operations. Evaluating processes, developing plans, and ensuring compliance with engineering standards.
About the role
- Senior Manager for GSK leading CMC regulatory strategies for vaccines in a cross-functional environment. Ensuring compliance and driving innovation across global regulatory activities.
Responsibilities
- Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with global standards.
- Prepare and review technical regulatory documents to support submissions and lifecycle management.
- Provide regulatory advice to cross-functional teams, including R&D, manufacturing, and quality assurance.
- Lead discussions with regulatory authorities and represent the company in external engagements.
- Identify risks and propose mitigation strategies to ensure smooth regulatory processes.
- Mentor and train team members, fostering a culture of continuous improvement.
Requirements
- Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field
- Solid and proven experience in CMC regulatory affairs
- Strong knowledge of global CMC regulatory requirements and drug development processes
- Proven ability to manage multiple projects and meet deadlines
- Must be fluent in English (both written and spoken)
- Master’s degree or PhD in a relevant scientific discipline (preferred)
- Regulatory Affairs Certification (e.g., RAPS) (preferred)
- Experience leading teams and managing complex regulatory submissions (preferred)
- Track record of effective negotiation with regulatory agencies (preferred)
- Excellent communication and collaboration skills (preferred)
- Proficiency in French is a plus (preferred)
Benefits
- Permanent contract in a very Inclusive environment
- Smart Working up to 50% for eligible roles
- Performance Reward
- Flexible Benefits
- Company Healthcare Plan
- Integrative pension fund
- Employee Assistance Programme
- Prevention services and vaccination clinic
- Tax assistance
- Local nursery agreement
- Postal service, laundry, shoe repair and tailoring
- On Site Gym
- On Site canteens and coffee corners
- Free company bikes and shuttle
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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