Regulatory Affairs Specialist
hace 1 mes
Galderma Pharma S.A. is seeking a highly skilled Regulatory Affairs Strategist to deliver innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities.
The successful candidate will be responsible for regulatory aspects related to clinical trial regulatory submissions in alignment with the global business strategy and in partnership with the functional subject matter experts within the Global R&D.
- Creating and managing clinical trial regulatory strategy for biologics, executing clinical trial regulatory activities in alignment with agreed clinical timelines.
- Oversight of clinical trial regulatory submissions, ensuring accurate and compliant dossiers.
- Archiving clinical trial documentation.
- Managing health authority interaction for assigned regions in alignment with agreed regulatory strategy.
- Identifying and assessing risks associated with the clinical regulatory submissions and recommend strategies to mitigate these risks.
Requirements:
- Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development.
- Experience with performing regulatory submissions in at least one key regulatory region.
- Excellent team interaction skills along with demonstrated ability to work on a cross-functional team.
- Ability to identify opportunities/major issues and to communicate impact.
What We Offer:
- A competitive compensation package with bonus structure.
- An extended benefit package.
- A hybrid work culture.
- The opportunity to work with a diverse and inclusive team.
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