Senior CMC Regulatory Strategy Manager

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Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities. You will work with cross-functional teams across development, manufacturing, quality and regulatory to prepare submissions and respond to regulatory requests. Your work will directly support timely access to medicines and continued supply for patients. We value clear communicators, pragmatic problem solvers, and collaborative colleagues who enjoy influencing technical and regulatory decisions. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Drives the CMC strategy, coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and taking into account the evolving regulatory requirements. Identifies risks to the business associated with submission data and information packages and provides and communicates well defined risk mitigation strategies. Mentors or trains staff. May have direct line management responsibility. Manages project activities for multiple complex projects and teams simultaneously, including those for reporting staff as appropriate. Provides strategic direction, data assessment and conclusions within and across departments. Able to establish organizational networks (internal and external) understanding departmental constraints/pressure within a highly complex organization Engages and may lead CMC Subject Matter Expert activities, both internally (for increased compliance, harmonization and efficiency) and externally (external advocacy and shaping the regulatory environment). May deliver CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (PIRCs). Has accountability for submission content. Understands, interprets and advises on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of biopharmaceutical products, to expedite submission, review and approval of global CMC applications. Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply. Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions. Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs ensuring optimum position for the company. Operates with considerable independence, except for matters that affect corporate or agency policies. Rapidly and appropriately communicates sensitive matters or those with potential for high business impact. May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects. Why You? Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals Bachelor's degree in life sciences, pharmacy, chemistry, engineering or related field. 6+ years of CMC regulatory experience in pharmaceutical, biologic, device or combination product development. Experience preparing and contributing to regulatory submissions (CTD modules, amendments, INDs, BLAs/NDAs or equivalents). Experience GMP and manufacturing processes and how they relate to regulatory submissions. Experience with complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment. Experience handling complex global CMC issues through continuous change and improvement. Experience in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management). Preferred Qualification If you have the following characteristic

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