Regulatory Affairs Specialist
hace 1 mes
At Galderma, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for delivering innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities. You will work closely with our global business strategy and functional subject matter experts within the Global R&D to ensure accurate and compliant dossiers.
Key Responsibilities:
- 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.
- Providing regular updates to global regulatory lead and indication regulatory leads regarding specific clinical trials.
- Managing of outside vendors.
- Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development.
- Experience with performing regulatory submissions in at least one key regulatory region.
- Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies.
- Experience interfacing with regulatory agencies and skill at implementing successful regulatory strategies.
- Experience with documenting regulatory strategies in coordination with clinical plans and marketing objectives.
- 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
- Demonstrated ability to deal with rapid change
- A competitive compensation package with bonus structure and extended benefit package.
- A hybrid work culture.
- Opportunities for professional development and growth.
- A diverse and inclusive work environment.
- Virtual conversation with the recruiter.
- Virtual conversation with the hiring manager.
- Panel conversation with the extended team.
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