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Director, Regulatory Affairs CMC

Waltham, Massachusetts; Collegeville, Pennsylvania; Rockville, Maryland; King of Prussia, Pennsylvania; Collegeville, Pennsylvania
Closing date
Feb 6, 2022

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Other, Legal/Regulatory Affairs
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Site Name: USA - Massachusetts - Waltham, Collegeville TSA, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Pennsylvania - King of Prussia, USA - Pennsylvania - Upper Providence, Ware Posted Date: Feb 2 2022 Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. This role will provide strategic direction and guidance on both global project and key strategic business initiatives. CMC Regulatory Affairs Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types, novel technologies, and multiple modalities for small and large molecules through to Cell and Gene Therapy The Director will lead key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceutical (therapeutic protein and/or cell & gene therapy) products. Scope of Responsibility Will serve as a key strategic partner representing Global CMC Regulatory on Regulatory Networks and Matrix Teams, providing and overseeing strategic direction and guidance to Biopharmaceutical and/or CGT R&D, Pharma Supply Chain, Clinical Trial Supply, Quality Assurance, and Commercial interfaces on both global project and key strategic business initiatives. May have direct line management responsibility. May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects. Delivers CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents (PIRCs). Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of GSK. Impact of Decisions Understands, interprets and advises on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biopharmaceutical products, to expedite submission, review and approval of global CMC applications. Ensures all appropriate strategic CMC regulatory aspects for clinical trials, product release and stability are in place, to avoid clinical holds, and to ensure continuity of market supply. Has accountability for information submitted in marketing applications to meet regional requirements, allowing maximum manufacturing flexibility and innovation while ensuring approvability. Directs resources to ensure all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines. Problem Solving Directs project activities and strategies for multiple projects and teams simultaneously, including those for reporting staff as appropriate. Provides strategic direction, data assessment and conclusions to senior management. Formulates novel approaches and influences people, systems and processes. Identifies key risks to the business associated with submission data and information packages and provides and communicates to senior management well defined risk mitigation strategies. Creates, maintains and continually evaluates/improves CMC Regulatory processes, policies and systems. Key individual in designing and/or implementing new and improved procedures to set standards and enhance the efficiency and quality of departmental work. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Biological sciences degree. CMC Regulatory leadership experience with biological medicines. (therapeutic proteins and/or cell & gene therapies) in late stage. development and/or commercialization. Preferred Qualifications: MSc. Or Ph.D. In biological sciences or engineering. Line management experience. 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, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritization, execution, delivering performance. Setting strategic direction and leading on-going organizational transformation. Building a resilient organization. Building strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit. Managing P&L and capital allocation. In return for your expertise, GSK will offer you the opportunity to showcase your skill set with a leadership that values, recognizes and rewards talent! #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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