Regulatory Affairs Specialist
4 settimane fa
We are seeking a highly skilled Regulatory Affairs Specialist to support the registration process of our Patheon Monza site as a manufacturer of sterile medicinal products in major markets.
About the RoleThis is an excellent opportunity to work on regulatory strategies, collaborate with clients, and ensure compliance with marketing authorization requirements.
Key Responsibilities- Support clients in defining the regulatory strategy for Patheon Monza site registration
- Write and review CTD Module 3.2.P Drug Product for new Marketing Authorizations, variations, and renewals
- Assist clients in responding to Regulatory Authorities Deficiency Letters
- Lead interactions with the Legal department and external services for notarization, legalization, and translation activities for Rest of the World registrations
- Ensure compliance with Marketing Authorization/CTA requirements in manufacturing processes and testing
- Graduation in Chemistry and Pharmaceutical Technology, Pharmacy, Biology, or Biotechnology
- Confirmed experience (3 years) in a Regulatory Affairs department for an FDA approved pharmaceutical company
- Expertise in writing/reviewing CTD Module 3.2.P Drug Product for sterile medicinal products
- Proficiency in EU/US and Rest of the World Submissions and handling documentation
- Familiarity with Directives, Regulations, Italian Laws, cGMP, GMP Annex 1, ICH/EMA/FDA Guidelines
An estimated salary of €65,000 - €90,000 per annum, depending on experience and qualifications.
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