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Regulatory Affairs Consultant

Regulatory Affairs Consultant

Real Staffing is currently looking for an RA Consultant to join one of our Global Pharma MNC clients in Malaysia to help them on their ongoing project. This is an exciting opportunity to work with the regional regulatory team in a fast-paced environment.

Location: Malaysia

Duration: 12-Month contract

Budget: Competitive Market Rate

Job responsibilities:

  • Manage the development of regulatory strategies to support the registration of clinical products, line extensions trial applications, new, major variations & lifecycle management.
  • Maintain licenses in compliance with local regulations by ensuring that corporate regulatory processes, SOP's and systems (e.g. CMC change control, product labelling, etc.) are in place.
  • Responsible for ensuring that all regulatory activities of existing licenses are compliant with local regulations, requirements and practices.
  • Responsible for developing and supporting relationships with key external agencies. Support the Health Authority interface throughout the lifecycle of a product.
  • Be accountable for regulatory compliance (of records and systems) within the area of responsibilities.
  • Oversee and/or facilitate strategic process improvements initiatives.
  • Ensure product strategies, submission approval time lines.

Qualifications:

  • Bachelor's Degree in Pharmacy or any related filed
  • At least 5 years of relevant experience in Regulatory Affairs
  • Experience across the Drug, Discovery, development and commercialization lifecycle, with proven examples of contribution.
  • Regional regulatory experience including knowledge of CTA's and NDA submission processes and product life cycle management activities.

If you are interested in the above described position, appreciate if you can click the link to apply 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 Global Recruiters 2017

Highly Commended for Best Large Recruitment Business 2017