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EA Licence: 11C3793

Regulatory Affairs Manager (9 months contract/ Pharmaceutical/ Bouna Vista)
Responsibilities
• Acts as a Business Partner to the Category and the LOCs and provides regulatory advice across NDH assigned products on aspects of drug development and regulatory requirements as appropriate
• Influences regulatory approaches within Project Teams to secure competitive approvals and speed to market in conjunction with LOC regulatory teams
• Communicates effectively within cross-functional Project Teams. May have to influence and negotiate with stakeholders
• Plans, prepares and delivers high quality regulatory files to agreed timelines. May have to ensure appropriate prioritization of high value initiatives over low value programs
• Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within Project Team
• In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc. with supply chain and technical excellence
• Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions

Requirements
• BA or BSc in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering). RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP in Regulatory Affairs, Pharmacy is a plus
• 4 to 6 plus years’ experience in Regulatory Affairs
• Product lifecycle support. Devises regulatory strategy and coordinate filing of submissions at a global level. Oversight of the defined products requires a strong background in medicines
• Scientific interpretation/ evaluation/ communication of technical information
• Ability to interface effectively with R&D, supply chain and commercial counterparts with credibility
• Project management skills
To apply, please visit to www.gmprecruit.com
To find out more about this opportunity, please contact Lionel Liew at lionel.liew@gmprecruit.com.
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Lionel Liew | Registration No: R1330693

   

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