GSK

Director, US Regulatory Affairs

Employer
GSK
Location
Warren, NJ
Salary
Competitive
Posted
November 03 2021
Ref
310875
Organization Type
Pharma
Site Name: USA - New Jersey - Warren Posted Date: Nov 3 2021 This position brings strategic regulatory leadership to OTC Drug products in the US portfolio. 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… Direct the strategy and execution of New Drug Applications for the portfolio, and actively manage the review and approval process, 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 OTC Monograph interpretation for products within portfolio, providing guidance to business and other stakeholders. Lead interactions (meetings, teleconferences) with regulatory authorities in order to seek guidance, expedite approval of pending applications and to resolve regulatory matters. Key internal advisor on existing and emerging regulatory trends for products/categories in remit. Interpret regulatory actions and provide the business and R&D with robust analyses and recommendations for action. Actively leads as a member of task forces and committees of trade associations Responsible for providing leadership, motivation, training, coaching and mentoring for staff Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering) Minimum of 10 years' experience in Regulatory Affairs 5 years experience in Consumer Health Strategic regulatory leadership experience Experience managing and leading teams Preferred Qualifications: If you have the following characteristics, it would be a plus: PhD or Masters' degree in life sciences or pharmacy Experience with Over-the-Counter drug products Strong track record with leading successful FDA meetings Proficient writer - effectively use fact and narrative to communicate complex regulatory concepts Effective communicator, skilled at developing and maintaining key relationships with internal and external contacts 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. *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.

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