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EA Licence: 09C3051
Global Regulatory Affairs (6 Months, Immediate starter, Digestive Health Therapeutic, Up to $9K)  

A well-established European Pharmaceuticals MNC. Responsibilities: ​​ ​ Provide regulatory Governance and expertise to NDH category such that Company's products are successfully introduced or maintained Globally. The individual will work with the NDH category and LOCs to ensure all regulatory requirements are met for both innovation and existing products. Key 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: Degree in Life Science or Pharmaceutical related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering). Candidate with RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP in Regulatory Affairs, Pharmacy is a plus. At least 5 to 10 years’ experience in Regulatory Affairs from Pharmaceuticals/Food Nutritions industry, preferably with relevant experience handling Digestive Health Therapeutic (OTC drugs and food supplements). Strong background in medicines, with experience in Product lifecycle support, devises regulatory strategy and coordinate filing of submissions at a Global level, and oversight of the defined products. Scientific interpretation/evaluation/communication of technical information is a must. Ability to interface effectively with R&D, supply chain and commercial counterparts with credibility. Excellent Project Management skills. Problem solving mindset, decision making ability, solution oriented. Ability to manage multiple stakeholders and juggle priorities. Excellent communication skills, both written and verbal. Able to start work immediately or within short notice. Able to commit for the entire contract duration.​ Other Information:​ Six (6) to Nine (9) Months' Contract. Working Location: Buona Vista. Working Hours: Mondays to Fridays, 8.30am to 5.30pm. To apply, please visit www.gmprecruit.com and search for Job Reference: 14016. To learn more about this opportunity, please contact Novita Tan at novita.adisutanto@gmprecruit.com We regret that only shortlisted candidates will be notified. GMP Recruitment Services (S) Pte Ltd | EA License: 09C3051 | EA Personnel: Novita Tan | Registration No: R1220374 Contact Person: Adisutanto, Novita - Reg No:R1220374 (novita.adisutanto@gmprecruit.com) 

 



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