GRCY-0, Regional Regulatory Affairs Senior Associate

2 days ago

Taguig, National Capital Region, Philippines Merck Healthcare Full time $90,000 - $120,000 per year

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

Your Role

  • Executes all regulatory submissions in the assigned APAC countries per regulatory and business requirements, for both product and clinical trial applications
  • Supports regional/local and global strategies, plans, and communicates registration and plans and generates options to obtain product approvals and supports product changes.
  • Ensures ready to submit dossier is available as per respective countries requirements through timely dossier compilation.
  • Coordinates labeling compliance and support promotional material process.
  • Ensures regulatory activities for the assigned Asian countries and portfolio are tracked irrelevant company systems according to compliant procedures.
  • Participates in business meetings with cross-functional teams & external customers and provide active and ongoing guidance within submission projects.
  • Assists Global Regulatory Affairs department in the update, enhancement & creation of internal procedures.
  • Reviews and assesses health authority regulations and competitor intelligence across Asia.
  • Able to travel as per business need.

As Regional Product Lead

  • Project Development
  • Strategy Alignment
  • Dossier Readiness
  • Application Submission
  • Applicatioon Approval
  • Product Maintenance

Country Point of Contact (PoC) / Sub PoC

  • Project Development
  • Strategy Alignment
  • Dossier Readiness
  • Application Submission
  • Application Approval
  • Product Maintenance
  • stakeholder Management

Who You Are

  • Degree or higher degree in Life Science, Pharmacy or related discipline
  • Excellent verbal and written English Skills.
  • Minimum of 3 years of regulatory experience in Pharmaceutical Product Registration and Clinical Trial application.
  • Demonstrated in- depth experience with preparation of regulatory documentation to support product and trial applications, as well as agency interactions. (FDA)
  • Thorough knowledge of NDA, CTA/ CTD requirements. – Clinical Trial application / Common Technical Documents, New Drug Application
  • Working knowledge in global organization with strong collaboration and stakeholder management skills, including cross functional
  • Experience with regulatory authorization in at least one of APAC country

What we offer:
We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity

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