1+ months

Senior Counsel Supply Chain

GSK
Warren, NJ 07059
Site Name: USA - New Jersey - Warren Posted Date: Apr 5 2022 This role will provide legal support to New Consumer Health on a wide variety of legal and compliance matters relating to the regulation of consumer healthcare products, including over-the-counter drugs and dietary supplements, by the U.S. Food and Drug Administration (FDA) and other consumer protection agencies. It will provide exposure to a broad range of legal, strategic and commercial issues affecting New Consumer Healths Quality and Supply Chain Organization and Research and Development Organization, including quality assurance, cGMP, pharmacovigilance, supply chain contracts, manufacturing site legal support, and EHS issues. The role will involve interaction with members of commercial teams, as well as close collaboration with attorneys from other practice groups within New Consumer Healths Legal and Compliance Organization. It will require advising on a wide variety of regulatory issues arising in the context of manufacturing and distribution operations, regulatory inspections, commercial transactions, disputes, and policy making. This role reports to the Assistant General Counsel and is based in Warren, NJ, but option to work remotely may be considered. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Lead legal support for quality matters, including advising Product Incident Review Committee on product incidents potentially involving market action Advise product development and Medical teams on matters relating to regulation of product ingredients and components, including GRAS, NDIs, Prop 65, pesticide residues, and packaging. Advising manufacturing sites on regulatory inspections, including drafting of responses to 483s. Anticipating and proactively supporting product quality and EHS risk management for Consumer Health Quality Supply Chain. Provide support to Consumer Health Care Quality Supply Chain on day-to-day matters impacting site operations including EHS regulatory requirements. Provide support to the US Consumer Health Contract Manufacturing Organization team including the negotiation of agreements for the supply of products and the resolution of commercial disputes that may arise. Identify new statutes, regulations, regulatory policies and guidance documents and advise on their application to New Consumer Health business operations. Provide support to trade compliance team on import/export regulatory matters. Collaborate with cross-functional attorneys on regulatory issues arising in a broad range of transactions, including business development, supply network strategy, research and development collaborations and divestments. This will include due diligence and negotiation and drafting of transactional documents. Engage and manage the activities of external legal counsel where appropriate. *LI-GSK Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Law degree Qualified lawyer, licensed to practice in at least one state, with experience in a law firm, government agency (e.g., FDA) and/or in-house, including relevant experience in Quality and GMP Regulatory counselling, US FDA and other key regulatory guidance and policies related to the manufacture and supply of consumer healthcare products. Familiarity with US regulatory framework applicable to a global consumer healthcare company, particularly as it pertains to the manufacture and distribution of over-the-counter drugs and dietary supplements. This should include, for example, familiarity with FDAs cGMP regulations pertaining to drugs and dietary supplements, the Dietary Supplement Health and Education Act (DSHEA), the Food Safety Modernization Act (FSMA), and the regulation of drugs marketed by authority of a new drug application or monograph under the Federal Food, Drug and Cosmetic Act (FDCA). Interpersonal skills, including those necessary to inspire the confidence and trust of senior leaders. Written and oral communication skills. Fluent in English. Preferred Qualifications: If you have the following characteristics, it would be a plus: Relevant in-house experience at a multinational pharmaceutical or consumer healthcare business, or at the FDA. Proven ability to influence and advise senior leadership and to manage across a matrix environment. Experience of advising on, drafting and negotiating manufacturing and supply agreements and/or procurement agreements in a regulated industry. Experience providing legal support for regulatory inspections, recalls and product incidents. Litigation experience involving regulated products. Experience with matters involving regulation by the Consumer Product Safety Commission, U.S. Department of Agriculture, Consumer Product Safety Commission, Drug Enforcement Administration, and Federal Trade Commission. Willingness to undertake domestic and international travel as required. 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, rigor 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. 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 GSKs compliance to all federal and state US Transparency requirements. For more information, please visit GSKs Transparency Reporting For the Record site.","street_address":"634 USA Posting Location",

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Posted: 2022-04-06 Expires: 2022-07-06

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Senior Counsel Supply Chain

GSK
Warren, NJ 07059

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