Director, CMC Regulatory Affairs
Site Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Rockville Biopharm, Switzerland - Zug, UK - Hertfordshire - Stevenage, USA - Maryland - Rockville, USA - Massachusetts - Waltham
Posted Date: Feb 15 2023
The Director will lead key, strategic CMC regulatory activities for investigational and/or early commercial biological products across multiple modalities. You will have the opportunity to globally strategize on a variety of therapeutics, collaborate across multiple service lines while building relationships with external constituents.
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 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.
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.
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s Biological sciences degree required.
Minimum 7 years of direct CMC Regulatory experience required.
Advanced biological sciences degree.
Line management experience.
Minimum 5 years CMC Regulatory leadership experience with biological medicines. (therapeutic proteins and/or cell & gene therapies) in late stage development and/or commercialization.
We’re uniting science, technology and talent to make a difference in more people’s lives, and revolutionising the way we do R&D. We’re combining the power of genetic and genomic insights into what causes disease, with the speed and scale of artificial intelligence and machine learning (AI/ML) to make better predictions about who a treatment might work for, and why. We believe this powerful combination of data and technology holds the key to fundamentally transforming medical discovery for the better, improving R&D success rates and shaping how even the most challenging diseases, like neurological conditions and cancer, can be both prevented and treated. No single scientist, nor any one technology can keep us all ahead of disease. That’s why we build important collaborations with commercial and academic partners to advance our understanding of disease and what it takes to get ahead. In the past three years, we’ve doubled the number of partnerships we’ve signed, because of our belief in their significant impact on our process. Our pipeline currently comprises of more than 60 vaccines and medicines across four core therapeutic areas including infectious diseases, HIV, oncology and immunology as well at pursuing other science-led opportunities outside our core areas. Many have the potential to be first or best-inclass opportunities for patients and since 2017, we’ve delivered 13 major approvals and more than doubled the number of potential new vaccines and medicines in Phase 3 and registration to 23. In 2021 we delivered four major product approvals: Cabenuva for HIV, Jemperli for endometrial cancer, Xevudy for COVID-19 and Apretude, our new long-acting medicine for HIV prevention. We give our scientists the freedom to own the process. Our scientists often use genetic data to help us understand the root cause of disease. We steer the research where the data shows we can do the most good. If a project doesn’t pan out, we take what we’ve learned and apply it elsewhere. Find out more:
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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