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Regional Regulatory Affairs Manager-Asia Pacific

Regional Regulatory Affairs Manager - APAC
Real Staffing is currently looking for a Regional Regulatory Affairs Manager to join one of our Global Pharma MNC clients and will be responsible for leading and providing region or country strategic input into the global regulatory strategy and identifying regional requirements for successful regulatory filings. This is an exciting opportunity to work with the local and regional regulatory teams.

Location: Singapore

Type: Contract, 7 Months

Key responsibilities:
* Understands regional and local requirements and advises the Global Regulatory Team (GRT) and Compound Development Team (CDT) on applicable regulatory requirements, guidelines and processes, region-specific regulatory issues with impact on the product strategy or deliverables.
* Provides guidance to local affiliates on development of strategies to accelerate submissions/approvals
* Serves as point of contact with local operating companies
* Ensures excellent collaborative relationship with key stakeholders including staff in the region and global R&D partners.
* Provides input to submission tactical planning and timelines including lifecycle submissions (labelling changes, renewals and safety reports).
* Updates HQ regulatory staff regarding changes in regional regulatory requirements and seeks to shape a favourable regulatory environment through networking with Industry Group(s).
* Provides support to VP, Regulatory Affairs AP to develop metrics for the region.

Qualifications:
* At least 5 years of relevant experience in regulatory affairs in pharmaceutical industries.
* Understanding of the pharmaceutical industry
* Knowledge of local laws, regulations and guidance's in the region related to full drug life cycle.
* Understanding of how laws, regulations and guidance's apply to specific projects. Ability to interpret them and understand them in the context of the scientific and commercial environment
* Understanding of and experience in drug development and/or marketed products
* Understanding of the scientific and medical principles applicable to the therapeutic area and specific products
* Awareness of pricing and reimbursement issues in AP
* Understanding of how supply chain decisions impact registrations in AP

If you are interested in the above described position, appreciate if you can click the link or contact Angelica Desiongco at +65 68009560 for a confidential discussion.

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 Gloabl Recruiters 2017

Application Email: AGDS.92854.3273@sthreesg.aplitrak.com
To be eligible to apply for this position you must be a Singapore Citizen or Authorized to work in Singapore.

Job Summary

Category & Subcategory:
Healthcare and MedicalOther Healthcare and Medical
Salary: Not Specified / month
Location: Central Area
Work Type: Contract
Career Level: Not Specified
Education: Not Specified
Experience: Not Specified
Ref Number: RE-32842275
Date Posted: Oct 06 2018
Advertiser: Real Life Sciences