Job Description

  • Evaluation and preparation of dossiers and technical documents for submission of new pharmaceutical and healthcare products
  • Ensure regulatory compliance of pharmaceutical and healthcare products throughout the product’s lifecycle
  • Identify risks and gaps that may impact implementation of local regulatory and commercialization plans
  • Develop innovative regulatory strategy to drive competitive advantage
  • Communicate and coordinate with various stakeholders (partners, cross-functional team, regional team, etc.) on regulatory status and updates
  • Represent company with various Regulatory Health Authorities (FDA, PDEA, BAI, etc.)
  • Prepare and review of artworks and labels for packaging artworks
  • Review materials and ensure compliance through Veeva
  • Execute key regulatory actions to support business requirements
  • Ensure adherence to current and new regulations
  • Cascade relevant and new regulations from governing bodies
  • Ensure database, reports, trackers are updated and provided on time
  • Provide support to the Regulatory Affairs Director in terms of regulatory strategy and regulatory intelligence to ensure speed to market of products and compliance with regulatory guidelines.
  • To provide regulatory training as required by the cross functional team.
  • Create SOPs, process updates to support regulatory function.
  • Active representation of the company with trade associations and ensure key company advocacies are pushed across.

Qualifications

  • B.S Pharmacy graduate and Licensed Pharmacist
  • At least 3 to 5 years managerial experience in Regulatory Affairs


Job Details

Role Level: Not Applicable Work Type: Full-Time
Country: Philippines City: Parañaque National Capital Region
Company Website: http://www.zuelligpharma.com Job Function: Engineering
Company Industry/
Sector:
Pharmaceutical Manufacturing Medical Equipment Manufacturing And Transportation Logistics Supply Chain And Storage

What We Offer


About the Company

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