CMC Regulatory Affairs Manager

Site Name: Richmond Sherwood, USA - New Jersey - Warren Posted Date: Jan 6 2022 The purpose of this role is to execute CMC regulatory activities for new products registrations and life-cycle maintenance (including variations, annual reports and annual notifications) for the portfolio of products defined by the US and Canada Business Units. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Responsible for CMC regulatory matters relating to registrations and/or life-cycle maintenance of business activities (including variations, annual reports and annual notifications) to support the US and Canada Business Units product portfolio. Preparation of CMC sections of new registration files (medicines, medical devices, cosmetics & foods), briefing books, clinical trials applications/INDs, CMC variations, responses to Regulatory Agency technical questions. Interacts with colleagues in other global functions (e.g. Technical and Supply Chain) and Regulatory Affairs subfunctions (Category and LOCs) to deliver high quality CMC sections for dossiers including documents & materials to local Regulatory Affairs in accordance with business priorities. Ensures close partnership with authors, assuring technical congruency and regulatory compliance. Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls. Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of appropriate internal compliance records e.g. change controls. Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete submissions. Develops up-to-date knowledge with regard to technical guidelines and regulatory requirements, as well as technical trends. 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) 5 + years' experience in Regulatory Affairs. Experience and knowledge in Quality, product development and manufacturing areas Preferred Qualifications: If you have the following characteristics, it would be a plus: RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QP 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.