Intern assisting in packaging development for major food industry company. Contributing to compliance analysis and audits while collaborating with engineering teams.
About the role
- Develop European and/or UK regulatory strategy for the designated program
- Contribute to clinical development plans to align diagnostic testing
- Act as representative of European regulatory team at global regulatory team for designated projects
- Drive strategy and oversee Dx/CDx and Device related content of regulatory documents
- Provide submission gap analyses, identify potential risks and propose solutions
- Oversee Dx/CDx and Device related regulatory agency communications, submissions, and approvals
- Lead and mentor team members
- Maintain up-to-date knowledge of laws, regulations, and guidelines across European regulatory authorities
Requirements
- Minimum of 10+ years’ experience in the biotechnical or pharmaceutical industry with a bachelor's degree
- Minimum of 10 years’ experience in a Regulatory capacity with increasing responsibility
- Seasoned negotiator with a solid background in medical devices/diagnostic development regulations
- Experience working with Notified Bodies and various Member State HAs
- Sound understanding of the drug and diagnostic development process
- Recent experience with diagnostic testing to support clinical trials in all phases of study
- Proven ability to deliver on goals in a cross-functional environment
- English native speaker preferred
Benefits
- Equal opportunity employer
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
NE
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