Regulatory Compliance Specialist

5 days ago


Dasmariñas, Calabarzon, Philippines Sydenham Laboratories Inc Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Pharmacist to join our team at Sydenham Laboratories Inc. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with changing regulatory requirements and guidelines in the pharmaceutical industry.

About You
  • You must have a pharmacy degree and valid registration as a pharmacist.
  • A minimum of 5 years' experience in a regulatory affairs role within the pharmaceutical or medical device industry is required.
  • You should have in-depth knowledge of regulatory requirements and guidelines in key markets, including the Philippines.
About the Role

This is a challenging opportunity to work closely with internal stakeholders and external partners to prepare and submit regulatory documentation, provide guidance on regulatory strategies, and identify potential risks to the business.

Key Responsibilities
  1. Stay up-to-date with changing regulatory requirements and guidelines in the pharmaceutical industry.
  2. Prepare and submit regulatory documentation, including marketing authorisation applications, clinical trial applications, and post-approval variations.
  3. Liaise with regulatory authorities to address queries and secure approvals for products.
  4. Provide regulatory guidance and support to research and development, manufacturing, and quality assurance teams.
  5. Maintain comprehensive records and databases to track the regulatory status of product portfolios.
  6. Identify and mitigate potential regulatory risks to the business.
  7. Contribute to the development and implementation of regulatory strategies aligned with commercial objectives.
What We Offer

In exchange for your expertise, we offer a competitive salary range of $80,000 - $110,000 per annum, depending on your level of experience and qualifications.



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