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Regulatory Affairs Specialist
Il y a 2 mois
We are seeking a highly motivated and detail-oriented Regulatory Affairs specialist to join our pharmaceutical company, ProductLife Group, as a Regulatory Affairs Specialist.
Key Responsibilities:- Submission and Approval Process:
- Prepare and submit Manufacturing License Applications (MLAs) to ensure compliance with regulatory requirements.
- Prepare and submit Technical/Site Transfer Applications to facilitate smooth transitions.
- Prepare and submit Marketing Authorisation Applications to secure product approvals.
- Lifecycle Maintenance:
- Prepare and submit documentation for post-approval applications, including Variations, Renewals, MAH Transfers/COAs, and Labeling.
- Compliance:
- Monitor and maintain up-to-date knowledge of national, European, and International guidelines/legislation to ensure regulatory compliance.
- Ensure compliance with all regulatory processes, in readiness for both internal and external audits.
- Ensure compliance with the regulations of the assigned Countries within European and International Regions.
- Communication:
- Act as a liaison between the pharmaceutical company and regulatory agencies to facilitate effective communication.
- Support internal requests for information to ensure seamless collaboration.
- 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, 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.
