Associate DRA Manager
COMMERCIAL OPS APAC SZ
Metro Manila, Philippines
17d ago

Job Description

1. Represent the company as official pharmacist, and the department for legal- and regulatory- matters.

2. Liaise with the local Health Authorities on matters pertaining to regulatory activities, licenses and permits for BD&L and launch products.

3. Assist DRA Head in the oversight of Sandoz Philippines Corp's compliance to all local and global regulatory rules and regulation to maintain legal business.

4. Plans, reviews and recommends the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for Sandoz BD &L and pipeline products based on regulatory expertise with country regulations & FDA processes.

5. Manages and ensures that the country Regulatory Plans are in alignment with Launch strategies, BD&L and the country’s business plan.

6. Participates in product teams and regularly coordinates with new product launch committee and BD&L group for updates on product approvals and launches with regard to implementation of regulatory requirements

7. Manage the final product submissions and negotiate and communicate effectively with HA to obtain timely approvals, including preparation and review of technical dossier within the planned timeline.

8. Represent company in regulatory public hearings, position papers, and other industry-association taskforce, and be up-

to-date with current local regulations and DRA organizational structure and potential changes that will impact the business environment.

9. Implement regulatory quality plan and QA systems and generate SOPs

10. Good Regulatory Practice

11. Oversight on artwork processes, it's accuracy and compliance with local requirements, and timeliness.

Minimum requirements

  • Bachelor of Science in Pharmacy, duly licensed by the Professional Regulation Commission;
  • Duly accredited by the FDA through QPIRA
  • Good spoken and written English
  • At least 5 years experience as a regulatory pharmacist, has experienced working with cross-functional teams i.e. marketing, launch teams and sales, with commercial sense
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