Regulatory Affairs Manager (1 year contract)

Vacancy number • D724B4D40AF82EBE97D11BD774203DA0

Regulatory Affairs Manager (1 year contract)

  • Singapore
  • Closes 22 February
  • 0 hours

Start the next chapter of your career

About this job

  • Branch:
  • Area of Expertise: Institutional Healthcare
  • Location: Singapore

What is required?

  • hours per week: 0
  • Education level:
  • Closing date: Thursday, 22 February 2024

About this role

Our client is a pharmaceutical company with a strong pipeline in biologics

  • Ensure appropriate oversight of NDA and Product Life Cycle Activities, such as: dossier author and review, licence renewal applications, regulatory compliance reviews, change of ownership applications
  • Formulate regulatory submission plans and work with cross-functional departments to support product launches and maintain product life cycle activities and ensure product compliance to regulatory requirements and standards.
  • Effective Coordination and Management of Regulatory Affairs activities in the region through prioritisation of submission activities across local affiliates/licensees
  • Co-ordinate and participate in preparations for Regulatory Authority meetings including development of regulatory strategy, questions, background documentation etc. as required to ensure that the objectives of the meetings are achieved.
  • Coordinate/participate in Project Planning Meetings as appropriate to ensure that the Project Team is provided with all required functional advice and support to drive project to completion.
  • Ensure adequate regulatory support is provided to the SMT to ensure successful New Drug Application approvals in affiliates and/or licensee, and timely clinical supplies.
  • Ensure third party contracts comply with any regulatory requirements (internal and external) if applicable.
  • Participate in monitoring activities (as requested by the SMT) to ensure performance according to internal SOPs as appropriate.
  • Ensure successful coordination with RA functional departments (e.g. strategy sub-function, dossier authoring function etc.) to prepare, review and finalise CTD/Submission package according to applicable internal SOPs and external guidelines.
  • Distribute and archive CTD/Submission package according to internal SOPs.

Why you should apply

This is an exciting opportunity in a well established global company. You’ll gain exposure to the APAC region, and will be working alongside a well supported RA team. There will be a chance of conversion for this position.

* Candidate must have experience in the pharmaceutical industry

What you should do now

Apply to this job ad or send your CV across to me at e.ng@brunel.net for a confidential discussion.

(Brunel International South East Asia Pte Ltd, Registration Number: 199603098R | Company License Number : 16S8067 | Eve Ng EAP Registration Number R2198025.)

About Brunel

Brunel is a leading provider of recruitment and workforce solutions throughout Asia and around the world. We excel at connecting specialist jobseekers with employment opportunities across conventional and renewable energy, life sciences, mining and manufacturing.

Our extensive network is comprised of 20 offices throughout Asia, including Brunel’s regional headquarters in Singapore and satellite offices across China, Japan, Malaysia, Indonesia, Thailand, Vietnam, South Korea and Taiwan + a further 100 locations worldwide.

Empowering people is our business. Our specialist recruiters strive to connect talented individuals with opportunities that align not only with your immediate expectations, but your long-term career trajectory as well. Brunel has built a reputation for working with some of the world’s largest and most innovative businesses. Talk to us about how we can help you to reach your goals.

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Brunel connects the most talented and experienced specialists with both present-day and pioneering projects. With 120+ offices and more than 12,000 specialists around the world, we deliver people and workforce services that transform global projects in Engineering & Construction, Oil & Gas, Renewable Energy, Mining, Infrastructure and Life Sciences.

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Brunel is passionate about ensuring we are a business with a conscience. Not only does Brunel have a defined global Environmental, Social and Governance (ESG) strategy, but we also have our own dedicated Brunel Foundation which has been working to ensure that we are contributing to a better future for both our people and planet for over 10 years.

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Start the next chapter of your career

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Do you have questions?

If you have questions or would like to discuss the details of this role, please contact Singapore quoting publication number: D724B4D40AF82EBE97D11BD774203DA0