- Posted 31 January 2023
- LocationMunich
- Job type Permanent
- Reference78678
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RA CMC Manager
Job description
RA MANAGER CMC (F/M/D)
Key Responsibilities
Qualifications
Who are you?
You possess the ability to communicator clearly and succinctly with a variety of stakeholders and are comfortable asserting your professional opinion when needed. Comfortable in your RA expertise, you look at the bigger picture and can lead a cross-functional project to success.
Key Responsibilities
- Responsibility for the lifecycle management (LCM), including market expansions, of vaccines
- Lead the regulatory submission strategy, identify submission risks and opportunities and execute through to approval
- Provide CMC regulatory advice to subject matter experts based on current regulatory guidance and sound scientific rationales
- Provide regulatory assessment to proposed CMC changes
- Lead the preparation of responses to questions from Regulatory Authorities for your area of responsibility
- Support the preparation and conduct of Agency meetings
Qualifications
- Degree within life sciences, preferably M. Sc. in chemistry or pharmacy, Ph.D. or similar
- Relevant experience (5-8 years) within the pharmaceutical or biotech industry, specifically within CMC regulatory affairs from a global perspective or a regulatory agency
- Background in vaccines is preferred
- Experience liaising with regulatory agencies
- In-depth knowledge of current global rules, regulations and guidance governing Regulatory LCM of drugs and biologics
- Fluent in English
Who are you?
You possess the ability to communicator clearly and succinctly with a variety of stakeholders and are comfortable asserting your professional opinion when needed. Comfortable in your RA expertise, you look at the bigger picture and can lead a cross-functional project to success.