Director, Regulatory Affairs CMC at GSK in Waltham, MA
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 expectationsare 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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 expectationsare 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.
Salary Range:
$80K -- $100K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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