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Regulatory Affairs Strategist: Drive Global Regulatory Excellence
hace 1 mes
Galderma is a global dermatology category leader, present in approximately 90 countries. We deliver innovative, science-based products and services that span the full spectrum of the fast-growing dermatology market. Our legacy in dermatology dates back to 1981, and we've dedicated our focus and passion to the human body's largest organ - the skin.
We're seeking a talented Regulatory Affairs Strategist to join our team. This role will involve delivering 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, working in alignment with the global business strategy and partnering with functional subject matter experts within the Global R&D.
Main 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 recommending strategies to mitigate these risks.
- Providing regular updates to global regulatory lead and indication regulatory leads regarding specific clinical trials.
- Managing 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.
- Excellent team interaction skills along with demonstrated ability to work on a cross-functional team.
- Ability to identify opportunities/major issues and communicate impact.
- Demonstrated ability to deal with rapid change.
- A competitive salary range of $80,000-$110,000 per year, depending on experience.
- A comprehensive benefits package, including extended benefits and a bonus structure.
- The opportunity to work in a hybrid work culture and participate in feedback loops, during which a personalized career path will be established.
- A growing company that believes in ownership from day one, empowering employees to grow and take on accountability.
At Galderma, we value diversity & inclusion and believe that reflecting the perspectives of our diverse customer base will lead to better outcomes. We're committed to creating an environment where everyone feels empowered to grow and thrive.
