Regulatory Affairs Manager

Warren, NJ
October 04 2021
Organization Type
Job Type
Site Name: USA - New Jersey - Warren Posted Date: Oct 4 2021 The Regulatory Affairs Manager brings strategic regulatory leadership to assigned products and projects. Trusted advisor to cross-functional partners, leads team to deliver well-constructed and considered regulatory strategies that meet consumer and business needs. Builds strong relationships with all stakeholders, internal and external This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Growth: Recommend and execute regulatory strategies for the portfolio, proactively seeking innovative and rapid path to market. Use internal and external networks to ensure regulatory strategies are robust and keep pace with the regulatory environment. Key advisor on the applicable regulations that govern products in remit, providing guidance and considering all possible interpretations and regulatory pathways. Strong understanding of regulations that cover assigned portfolio (US Monograph, NDA, Devices, DSHEA, etc.) Collaborate with Global and US stakeholders (commercial, Global Reg, R&D etc) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and POS Deliver Regulatory support and guidance to ex-US markets for brands where US is the Lead Market (as defined through SRA) Participate in interactions (meetings, teleconferences) with regulatory authorities in order to seek guidance, expedite approval of pending applications. Develop direct reports to have strong regulatory capabilities Stewardship: Accountable for the ongoing end-to-end regulatory compliance of products in remit. Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated. Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business. Maintain high level of knowledge on the science of products within defined portfolio. External Engagement: Key internal advisor on existing and emerging trends for products/categories in remit. Anticipate threats and opportunities. Interpret regulatory actions and provide the business and R&D with robust analyses and recommendations for action. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree Life Science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering) 5 + years' experience in Regulatory Affairs 2 + years experience in Consumer Health Preferred Qualifications: If you have the following characteristics, it would be a plus: RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. 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