Regulatory Affairs Manager
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. Budgeting and cost-consciousness. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.