Regulatory Affairs Specialist

4 weeks ago

Singapore ProductLife Group Full time
We are looking for a highly motivated and detail-oriented Regulatory Affairs Specialist to join our consulting company. As a Regulatory Affairs Specialist, you will play a crucial role in ensuring compliance with regulatory requirements for the development, approval, and marketing of pharmaceutical products on a global scale.Your responsibilities will include managing the submission and approval process for various applications such as Manufacturing License Application (MLA), Technical/Site Transfer Applications, and Marketing Authorisation Applications. You will also be responsible for lifecycle maintenance activities, including preparing and submitting documentation for post-approval applications like Variations, Renewals, MAH Transfers/COAs, and Labeling.In addition, you will be required to stay informed about national, European, and International guidelines/legislation to ensure compliance with regulatory processes. You will act as a liaison between the pharmaceutical company and regulatory agencies, supporting internal requests for information.To be successful in this role, you should have 5-8 years of relevant experience in Regulatory Affairs internationally, with a strong background in lifecycle maintenance. Experience with applications such as MLA, MAA, CTD, Variations, Renewals, and Labeling is essential, along with familiarity with European Regulatory Authorities.Proficiency in software packages and databases such as Microsoft Office Suite, Veeva Vault, LorenZ, Trackwise, and PromoMat is required. Strong organizational and communication skills, the ability to prioritize tasks effectively, and a track record of delivering high-quality work are also important for this role. Experience in people management/coordination and promotional/non-promotional activities would be considered a plus.,

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