Regulatory Affairs Director, Allergy & Smoker's Health
As the Regulatory Affairs Director of Allergy and Smoker's Health, you will provide regulatory leadership, governance and expertise to the Allergy and Smoker's Health portfolio of GSK Consumer products such that our products are successfully introduced or maintained Globally. In this role, you will build a network of collaborative relationships across the Category and LOCs and will set a compelling vision for the team and deliver against the Category strategy and mission, ensuring all regulatory requirements are met for both innovation and existing products according to GSK Values. The Director role requires development of capability and talent within a team of six, as necessary to implement strategy.
•Acts as a Business Partner and provides regulatory advice across Category/sub-Category on all aspects of drug/cosmetic/devices/food and supplements (dependent on category) development and regulatory requirements, both current and future.
•Provides regulatory direction for this significant portfolio of products. Develops novel regulatory strategies and influences approaches, in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams.
•Communicates, influences and negotiates effectively with cross-functional internal and external groups at all levels.
•Where the role has direct reports, build, maintain and lead an efficient and well-motivated team; ensure effective development, retention and recruitment into the group.
•Ensure appropriate prioritization and resourcing of projects to deliver high quality regulatory files to agreed timelines.
•Leads significant non-product related activities, both in the function and cross functionally, in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage.
•Influence the external regulatory environment through networking with key individuals, identifying opportunities and influencing guidelines. May act as GSK representative to external groups for specific topics (e.g. AESGP, Cosmetics Europe).
•Ensure the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within Copy Review Committee and with senior stakeholders.
•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 Oversees compliance in all actions by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.
Bachelors in Life Science or Pharmaceutically -related science (Chemistry, Pharmacy,
Biochemistry, Biology, or Medical Engineering).
A minimum of 10 years' experience in Regulatory Affairs, with at least 5 years at a senior manager level . Pharmaceutical RA expertise with RX to OTC experience.
Demonstrated experience in US & European procedure for drug registration (drug filing and different aspects of obtaining United States Food & Drug Administration (USFDA) and European Medicines Agency (EMA) approval
RAC, Masters (MBA, MS, MA), or PhD/Pharm D /JD QP
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires
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