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Regulatory Affairs Specialist
il y a 1 mois
We are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join our pharmaceutical company. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products globally (internationally).
Key Responsibilities:- Submission and Approval Process:
- Preparation and submission of Manufacturing License Application (MLA)
- Preparation and submission of Technical/Site Transfer Applications
- Preparation and submission of Marketing Authorisation Applications
- Lifecycle Maintenance:
- Preparation and submission of documentation for post-approval applications including, but not limited to, Variations, Renewals, MAH Transfers/COAs, Labeling
- Compliance:
- Monitor and maintain up-to-date knowledge of national, European, and International guidelines/legislation
- Ensuring compliance with all regulatory processes, in readiness for both internal and external audits
- Ensuring compliance with the regulations of the assigned Countries within European and International Regions
- Communication:
- Act as a liaison between the pharmaceutical company and the regulatory agencies
- Support internal requests for information
- 5-8 years of relevant experience in Regulatory Affairs Internationally
- Lifecycle maintenance experience
- Experience with: MLA, MAA, CTD, Variations, Renewals, Labeling Applications
- Experience working with European Regulatory Authorities
- Experience with software packages and databases (Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc.)
- Good organizational skills and communication skills
- Ability to prioritize and deliver high-quality work
- Experience in people management/coordination is a plus
- Experience in promotional/non-promotional activities is a plus
