Regulatory Affairs Specialist
hace 4 semanas
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Alk-Abelló A/S. As a key member of our regulatory team, you will be responsible for handling CMC documentation for products manufactured at our site in Madrid, ensuring compliance with local and regional requirements.
Key Responsibilities:
- Coordination and preparation of CMC documentation for Marketing Authorisation Applications, Variations, and Renewals
- Submission of CMC documentation to regulatory authorities
- Handling product information, including SmPCs, leaflets, and labels
- Regulatory surveillance and support to other functional areas
Requirements:
- 3+ years of experience in Regulatory Affairs, preferably in a pharmaceutical company
- Experience in international projects and regulatory affairs courses
- Bachelor's or Master's degree in Health Science or a related field
Important Tasks:
- Coordination and preparation of CMC documentation for post-approval regulatory commitments
- Handling national phase of variations/MAA submitted by European procedures
- Preparation and submission of documentation for special licenses/import licenses
What We Offer:
- A dynamic and collaborative work environment
- Opportunities for professional growth and development
- A competitive salary and benefits package
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