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Senior Manager Regulatory Affairs - OTC

Employer
GSK
Location
Warren, NJ
Salary
Competitive
Closing date
May 22, 2022

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Discipline
Other, Legal/Regulatory Affairs
Job Type
Manager
Organization Type
Pharma
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Site Name: USA - New Jersey - Warren Posted Date: Apr 1 2022 Are you interested in a highly-visible US Regulatory Affairs - OTC role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Manager could be an ideal opportunity to explore. As a Regulatory Affairs Manager, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US. This position has responsibility for strategic end-to-end regulatory activities for the assigned portfolio. Develops and executes well-constructed and considered regulatory strategies that meet consumer and business needs. Builds strong relationships with all stakeholders. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Growth: Lead preparation of new regulatory documents, dossiers and applications to enable new products to be launched and maintained in market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market. 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. 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. Monitor and analyse regulatory environment for trends, possible threats and opportunities. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree 8 + years of experience in Regulatory Affairs 3 + years in Consumer Health - OTC (over the counter) Experience with US regulatory environment Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree in Pharmacy, Chemistry, Biology, Medicine, or similar discipline RAC certification Experience at a large global pharmaceutical or vaccines company 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: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *This is a job description to aide in the job posting, but does not include all job evaluation details. 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.
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