Senior Regulatory Affairs Manager, APAC

Location: Singapore
Salary: competitive
Job Type: Permanent
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Senior Regulatory Affairs Manager, APAC

Key Responsibilities:

  • Execute regulatory strategy and drive new products, change notifications, and renewals for the APAC region
  • Liaise with distributors for submissions and life-cycle management
  • Ensure implementation of growth, brand value and other programs, contribute regulatory expert input in development of business plans, regulatory strategies and on issues management
  • Identify the gaps and define contents for regulatory dossiers
  • Work proactively to mitigate and eliminate regulatory-related risks and formulate back-up plans (e.g. rationale letters, monitoring gaps and follow up to ensure the information availability at input request)
  • Keep abreast and updated with new regulations and industry practices that will impact the business - identify regulatory risks/opportunities and propose strategies to address these risks
  • Responsible for achieving compliance and meeting time-lines
  • Review product labelling and promotional material review
  • Provide regular updates to stakeholders on new regulations and policies in SEA and South Asia as part of Regulatory Intelligence and analyse impact of change on the business
  • Execute key opinion leader (KOL) identification and engagement strategies across the portfolio to support the commercial and scientific objectives of the company
  • External engagement with strategically important agencies and KOLs on shaping regulatory landscape to influence positively on policies and market practices

The ideal candidate should possess:

  • Have a minimum of 7-9 years of regulatory experience
  • Registered pharmacist
  • Regional experience is ideal but not preferred

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

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

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