Site Name: USA - Massachusetts - Waltham, Durham Blackwell Street, Switzerland - Zug, UK - Hertfordshire - Stevenage, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Pennsylvania - Upper Providence
Posted Date: Apr 26 2023

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.

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

The Director will lead key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceutical 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, 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 or act as individual contributor.
• 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.
• Ensures 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 reporting staff if applicable. 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.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Biological sciences degree
• 7 or more years of direct CMC Regulatory experience
• Experience leading key, strategic CMC regulatory activities for investigational and/or early commercial biopharmaceuticals
• Experience working in large enterprise company leading complex projects
• Experience working with new drug applications in the US or EU
• Experience creating Regulatory strategy and executing on those plans

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Advanced biological sciences degree
• 5 or more years CMC Regulatory project leadership experience with biological medicines. (Therapeutic proteins and/or cell & gene therapies)
• Ability to demonstrate flexible thinking and high resilience in the workplace
• Ability to work with frequent changing priorities within a fast-paced work culture

Why GSK:

We’re uniting science, technology and talent to make a difference in more people’s lives, and revolutionizing 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.

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-in-class 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.

Find out more:

Our approach to R&D.

#LI-GSK

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 positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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