Regulatory Affairs CMC Specialist
hace 1 mes
About Galderma
We are a leading dermatology company with a unique legacy and decades of innovation. Our focus is on advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning, and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and healthcare professionals.
Job Title: Regulatory Affairs CMC Specialist
Location: Barcelona
We are seeking an expert in Regulatory Affairs to prepare and update the CMC (Chemistry, Manufacturing, and Control) dossier sections of assigned products. This person will contribute to develop RA-CMC strategies for geographical extension and for post-approval CMC activities.
Key Responsibilities:
1. Contribute to global regulatory CMC strategies.
2. Assess regulatory impact of proposed CMC changes and contribute to the CMC regulatory strategies that support change implementation.
3. Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to solve them.
4. Write/assemble CMC sections of regulatory submissions.
5. Develop and maintain project plans and schedules for CMC submissions.
6. Ensure all CMC dossiers are stored in the company database.
7. Provide guidance on ICH, FDA, and EU CMC guidelines.
8. Develop and maintain excellent relationships with internal functional groups, contract manufacturing organizations, and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory goals.
9. Share knowledge and experience with other team members.
10. Collaborate with service providers contracted to support a project, if appropriate.
Skills & Qualifications:
- Effective experience in CMC Regulatory Affairs.
- Background in pharmaceutical industry.
- Experience with topical and/or systemic drugs (Biologics and/or Small Molecules).
What we offer:
We are an organization that embraces diversity and inclusion. We believe that we will deliver better outcomes by reflecting the perspectives of our diverse customer base. We offer a competitive compensation package with bonus structure and extended benefit package. We work in a hybrid work culture. We participate in feedback loops, during which a personalized career path will be established. We are a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability.
Process Steps:
1. Send your CV in English.
2. If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.
3. The next step is a virtual conversation with the hiring manager.
4. The final step is a panel conversation with the extended team.
We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
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