Senior Regulatory Affairs Analyst at Johnson & Johnson, responsible for ensuring compliance and regulatory strategy in São Paulo. Involves preparation and submission of regulatory dossiers and compliance assurance.
About the role
- Regulatory CMC Manager supporting multi-product global regulatory CMC for products at Marketing Authorisation Application Stage. Focused on documentation preparation, submissions, and providing regulatory support.
Responsibilities
- Support the execution of multi-product global regulatory CMC for products at Marketing Authorisation Application Stage
- Contribute to the preparation and submission of regulatory CMC documentation
- Provide regulatory support to various cross-functional teams
- Contribute to strategic Regulatory CMC discussions
Requirements
- Experienced CMC Regulatory Manager
- Authoring of CMC sections for Marketing Authorisations dossiers
- Reviewing CMC sections of regulatory submissions
- Working with regulatory colleagues in development of global regulatory CMC strategies and submissions
- Participating on cross-functional teams and serving as the primary regulatory CMC contact for assigned products and projects
Benefits
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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