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Global Regulatory Compliance Specialist

3 weeks ago

Singapore beBeeRegulatory Full time $120,000 - $180,000

We are seeking a skilled Regulatory Affairs Professional to play a critical role in ensuring global compliance with regulatory requirements for pharmaceutical products.

Key Responsibilities:
  • Manage the submission and approval process for applications such as Manufacturing License Applications (MLAs), Technical/Site Transfer Applications, and Marketing Authorisation Applications.
  • Perform lifecycle maintenance activities, including preparing and submitting documentation for post-approval applications like Variations, Renewals, MAH Transfers/COAs, and Labeling.
  • Stay informed about national, European, and International guidelines/legislation to ensure compliance with regulatory processes.
  • Act as a liaison between the pharmaceutical company and regulatory agencies, supporting internal requests for information.
Required Skills and Qualifications:
  • 5-8 years of 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.
  • Familiarity with European Regulatory Authorities is required.
  • Proficiency in software packages and databases such as Microsoft Office Suite, Veeva Vault, LorenZ, Trackwise, and PromoMat.
  • Strong organizational and communication skills, the ability to prioritize tasks effectively, and a track record of delivering high-quality work.

Becoming a part of our team will bring you opportunities to grow professionally and make a meaningful impact in the industry.