Major Accountabilities
- Life Cycle Management of Marketing Authorizations (MAs):
- Manage MAs throughout their life cycle, focusing on major markets like EU, US, Canada, Japan, Australia, Brazil, China.
- New Submissions and Planning:
- Plan and execute new submissions in Most of World (MoW) regions as per set targets.
- MA Transfers:
- Responsible for transferring MAs and maintaining product history within defined timelines and processes.
- CMC Documentation:
- Author and organize high-quality CMC documentation (dossiers) for health authority submissions, ensuring technical congruency, regulatory compliance, and meeting e-publishing requirements.
- Variations Submissions:
- Handle work-sharing and super grouping variations submissions.
- CMC Responses:
- Prepare CMC responses to health authority questions during development, registration, and throughout the product lifecycle.
- Regulatory Evaluation:
- Evaluate change controls and other quality events for regulatory impact, including administrative changes.
Minimum Requirements
- Experience in regulatory affairs, specifically in CMC documentation and submissions.
- Familiarity with international regulations, especially in major markets.
- Strong organizational skills and ability to manage multiple projects.
- Excellent communication skills and ability to work effectively in a team.
