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Regulatory Affairs Manager

Salary undisclosed

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I am seeking a highly skilled Regulatory Affairs Manager with expertise in generic drugs manufacturing to join a leading pharmaceutical team based in the vibrant city of Selangor, Malaysia.

In this vital role, you’ll be instrumental in guiding the company's generic pharmaceutical products through the complexities of international markets, across the North Asia, Southeast Asia, and ANZ regions respectively. You’ll ensure our generics comply with global regulatory standards and build strong relationships with regulatory authorities to facilitate smooth approvals.

Qualifications for this Regulatory Affairs Manager role are:

  • At least 8 years of experience in regulatory affairs with a specialization in generic drugs within the pharmaceutical industry. International experience is advantageous.
  • Demonstrated proficiency in API DMF reviews and adeptness in managing a portfolio of generic products across various markets.
  • Comprehensive understanding of regulatory requirements and submission processes for generics in major regions, including North Asia, Southeast Asia, and ANZ.
  • Proven track record of effectively working with subsidiaries and business partners on regulatory filings for generics.
  • GCP certification is considered a valuable asset.

Apply now for a confidential discussion about this impactful and strategic Regulatory Affairs Manager role in generic drugs manufacturing.

CEI: R2090154 | Licence No.: 22S1313