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Senior RA Specialist

Regulatory Affairs, Senior Specialist

Job Description

  • Strategise and plan regulatory filings for timely submissions and approvals of variation applications and product registrations
  • Maintain life cycle management of existing product portfolio
  • Manage labeling changes, safety updates, artwork development and artwork approval of packaging material components.
  • Build effective working relations with regulatory agencies
  • Work effectively with different functions to develop and implement the regulatory strategies and plans to support commercial goals etc.
  • Support and develop annual regulatory budget for Singapore variations/registrations/license renewals.
  • Review promotional material for product campaign launches and ongoing product marketing activities.
  • Update and maintain local and global-associated databases
  • Keep updated on the latest pharmaceutical regulatory developments

Quality Assurance

  • Involve in local in-licensing project
  • Support quality audit and ensure product complaints are handled accordingly
  • Responsible for updating the competent authority on any products recalls, withdrawal or defects and any other product quality related safety issues.
  • Escalate matters based on any critical quality and regulatory compliance issues

Requirements:

  • A reputable University Degree in Pharmacy
  • 3-5 years of RA experience
  • Good communication skills
  • Registered pharmacist
  • Experience working with local health authorities

If you meet the essential requirements for this position, please send your latest CV through the link provided , or call Vanessa Tan at +65 6871 4700 for further information.

Only shortlisted candidates will be notified via email.

If you meet the essential requirements for this position, please send your latest CV through the link provided , or call Vanessa Tan at +65 6871 4700 for further information.

Registration no: R1873695

EA Licence no: 16S8216

Only shortlisted candidates will be notified via email.

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

Award winner of:

International Recruitment Company of the Year by Recruitment International 2016

Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016

Best Overseas Operation by Global Recruiters 2017

Highly Commended for Best Large Recruitment Business 2017