Director, CMC Regulatory Affairs-Mature Products

Site Name: USA - Pennsylvania - Upper Providence, UK - London - Brentford, USA - Maryland - Rockville, USA - Massachusetts - Waltham Posted Date: Apr 13 2022 We have an exciting opportunity at GlaxoSmithKline (GSK) for a highly innovative Director, Regulatory Affairs- CMC Biopharm Mature products to lead CMC regulatory activities in the global lifecycle management of GSK biopharmaceutical products. You will have management oversight for a team ensuring compliance with GSK policies and procedures, staff development and training to deliver roles. This role will provide YOU the opportunity to lead key activities to progress YOUR career. Key Responsibilities: Represents Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing and overseeing strategic direction and guidance to Supply Chain, Quality Assurance, 3rd Party Contract Management, Commercial and wider GRA on both global project and key strategic business initiatives. Identifies key risks to the business associated with submission strategy and information packages and provides and communicates to senior management well defined risk mitigation strategies. Likely to have direct line management responsibility. Coaches and mentors staff across CMC RA on lifecycle management in CMC. Responsible for managing budget and resource for their teams . Responsible for team compliance with GSK policies and procedures, staff development and training to deliver roles. Has effective organizational (internal and external) networks. Leads influences and motivates staff within and across departments. Commercially astute and organizationally aware and able to deal with sensitive and confidential issues. 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 (e.g. PAI's) or quality incidents (LICs/PIRCs). Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of the company. Leads the company position to influence the internal/external CMC Regulatory environment through specialist areas of intelligence. Has accountability for submission content. Understands, interprets, and advises on regulations, guidelines, procedures, policies, and strategies relating to development, registration, and manufacturing of pharmaceutical products, to expedite submission, review, and approval of global CMC applications in alignment with regional requirements. Directs resources (across multiple projects and teams simultaneously) to ensure all appropriate CMC regulatory aspects across teams to support license maintenance and change control requests including transfer of supply within the company or with a 3rd party are delivered to agreed timelines. Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies, and systems to enhance the efficiency and quality of departmental work. Operates with independence. Directs and communicates complex regulatory issues independently at senior levels across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs ensuring optimum position for the company. Why you? Basic Qualifications: 5-10 years Post Approval CMC Regulatory experience for biopharmaceutical products Experience in leading major post-approval filing activities for biopharmaceutical products (e.g. significant manufacturing change and key regulatory interactions in lifecycle management) Able to demonstrate the following key high performance behaviors: customer driven, flexible thinking, and continuous improvement Detailed knowledge of biopharm drug development and manufacturing and supply processes and may have a specialized area of expertise. Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment in the biopharm space. Proven project management and multi-tasking skills. Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and personnel within the company in a variety of settings. Demonstrated ability to handle complex global CMC issues through continuous change and improvement. Preferred Qualifications: Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines product support. Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements. Identified as CMC Regulatory expert in a specific subject area. Proven experience in supervising and training staff within and across the organization. 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 collaborating In return for your expertise, we 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. 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