GSK

Sr. Manager, Regulatory Affairs Rx to OTC Switch

Employer
GSK
Location
Warren, NJ
Salary
Competitive
Posted
November 02 2021
Ref
310181
Organization Type
Pharma
Job Type
Manager
Site Name: USA - New Jersey - Warren Posted Date: Nov 2 2021 The Sr. Manager Regulatory Affairs - RX to OTC Switch will play an important role progressing switch opportunities. The purpose of this role is to support the activities of the Switch team by developing and executing robust regulatory strategies that leverage advancing science and research techniques. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Develop and execute regulatory strategies in support of IND and NDA submissions for Switch opportunities Draft and evaluate OTC Drug Facts Labels, Consumer Information Leaflets, and behavioral support materials to ensure they meet regulatory requirements and consumer needs Advise on design of assigned development programs, including label comprehension studies, self-selection studies, actual use trials and tailored consumer studies. May include oversight of study execution. Oversee development of all sections of assigned applications, to ensure consistent messaging an on time delivery. Primary author for Module 1. Identify data needs and develop specialized research to support product approval and marketing claims Lead preparation for meetings with regulators, other policy makers and stakeholders, including preparing reports, presentations and manuscripts Drive GSK NSURE agenda, collaborating with internal stakeholders and external experts to make a positive impact on consumer comprehension, selection, access models and compliant use of new products. For new switch opportunities, support Switch team with comprehensive regulatory assessment of feasibility based on a comprehensive assessment of the science and the issues likely to be raised by the switch 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); Social Sciences with commensurate experience. 8 + years' experience in Regulatory Affairs, 5 in Consumer Health. Other relevant behavioral experience will be considered. Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced degree in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering); Social Sciences with commensurate experience. Social Sciences/Research and/or FDA experience are highly desirable for this role. 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.

Similar jobs

Similar jobs