GSK

Director, US Regulatory Compliance

Employer
GSK
Location
Warren, NJ
Salary
Competitive
Posted
September 27 2021
Ref
306270
Organization Type
Pharma
Site Name: USA - New Jersey - Warren Posted Date: Sep 27 2021 Are you energized by facilitating and leading the most effective enterprise wide risk strategy? If so, this Regulatory Compliance Director role could be an ideal opportunity to explore. To provide Regulatory Leadership for local regulatory operational and compliance activities for US and Puerto Rico. Areas included within the scope of Regulatory Compliance include: local labelling compliance, compliance with local administrative regulatory requirements, local adoption of and adherence to Global Regulatory internal SOPs and training, local process improvement and development. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Direct and manage a team of professionals to ensure the LOC maintains compliance with labelling, local listing and other administrative requirements Provide leadership, definition, and oversight from an Enterprise perspective for significant regulatory compliance escalations; participate in LICs and PIRCs as the US Regulatory representative, when required. Oversee the regulatory compliance aspects of local labeling processes, such as the creation and maintenance of labeling content and local implementation of updates. Oversee the local compliance of regulatory documentation systems (eg OPAL) Ensure all local administrative regulatory requirements are met (e.g. drug listing, establishment licensing) for US, PR. Ensure written processes and procedures are in place within the US and PR Regulatory Affairs with associated training plans, tracking, internal assessment and KPIs aligned to GSK CH policies. Ensure changes in the regulatory environment that impact regulatory compliance are identified and incorporated into local practices with minimal disruption to business continuity. Drive process improvement for the department, identify opportunities to use AI or Digital technologies to improve compliance while also improving efficiency. Represent RA in compliance forums (e.g. SOP committees, process improvement), ensuring that local needs and requirements are addressed. Strong partner with the Global Regulatory Operations and Submissions teams as well as cross-functionally Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree specializing in Life science/Pharmaceutically-related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering) 10 years experience in a pharmaceutical or consumer goods environment, at least 5 directly working with labeling or quality processes Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's degree (MBA) or related Experience with OTC is desireable Experience with change management and lean processing 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. *LI-PRO 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. 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.