Director, CMC Regulatory Affairs
GlaxoSmithKline, Collegeville, PA, United States
Locations: UK - Hertfordshire - Ware RD, Belgium-Wavre, GSK HQ, Italy - Siena, Switzerland - Zug, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence
Position Summary You will lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products. You will work across R&D, supply, quality and commercial teams to enable development, approval and uninterrupted supply. This role offers visible impact, professional growth, and the chance to help GSK unite science, technology and talent to get ahead of disease together.
Responsibilities
Lead CMC regulatory strategy for investigational and early commercial biological products across global teams. Understand, interpret and advise on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biological products, to expedite submission, review and approval of global CMC applications.
Serve as a key strategic partner representing Global CMC Regulatory on cross-functional networks and matrix teams, advising R&D, supply, clinical trial supply, quality and commercial stakeholders.
Own submission content and ensure regulatory requirements for clinical trials, product release and stability are in place to avoid clinical holds and protect supply.
Participate in corporate evaluation and provide CMC regulatory support/advice to in‑licensing and divestment projects.
Involve in and lead current business‑critical activities across internal and external networks on behalf of GSK.
Identify regulatory risks and propose clear mitigation plans to senior leadership.
Support major inspections and quality incidents by producing regulatory strategy and managing regulatory interactions.
Mentor and develop regulatory colleagues, act as an individual contributor or may have direct line management responsibilities as per business needs.
Accountable for information submitted in marketing applications to meet regional requirements, allowing maximum manufacturing flexibility and innovation while ensuring approvability.
Ensure all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a third party are delivered to agreed timelines.
Problem Solving Skills
Direct project activities and strategies for multiple projects and teams simultaneously, including reporting staff if applicable. Provide strategic direction, data assessment and conclusions to senior management.
Formulate novel approaches and influence people, systems, and processes.
Identify key risks to the business associated with submission data and information packages and provide and communicate to senior management well defined risk mitigation strategies.
Create, maintain and continually evaluate/improve CMC Regulatory processes, policies, and systems.
Design and implement new and improved procedures to set standards and enhance the efficiency and quality of departmental work.
Qualifications
Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
Extensive CMC regulatory experience in biopharmaceuticals, including experience with development and manufacturing requirements.
Preferred Qualification
Advanced degree (MSc or PhD) in a relevant scientific discipline.
Experience leading CMC regulatory teams or line management responsibility.
Experience with lifecycle management and post‑approval regulatory activities.
Experience with cell and gene therapies, therapeutic proteins or other complex biologics.
Demonstrated success leading major inspections or regulatory interactions.
Practical experience with global regulatory frameworks and agency engagement.
Experience with mentoring junior colleagues.
Proven track record preparing or contributing to global CMC submissions.
Experience engaging with cross‑functional teams across R&D, supply and quality.
Strong written and verbal communication skills for interacting with internal stakeholders and regulatory authorities.
Ability to manage multiple projects, set priorities and meet timelines.
Working pattern and location This role can be based in the United Kingdom (Ware, Stevenage or HQ), United States (Upper Providence or Waltham), Belgium (Wavre), Italy (Siena) or Switzerland (Zug). The position is offered as a hybrid role with a balance of on‑site and remote working. Specific on‑site days will be agreed with your manager to support team collaboration and stakeholder engagement.
Benefits Salary ranges for this position vary by location (e.g., UK base salary ranges £75,000–£120,000, US base salary $173,250–$288,750), and include an annual bonus and eligibility to participate in a share‑based long‑term incentive program. Benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Equal Employment Opportunity GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
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Position Summary You will lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products. You will work across R&D, supply, quality and commercial teams to enable development, approval and uninterrupted supply. This role offers visible impact, professional growth, and the chance to help GSK unite science, technology and talent to get ahead of disease together.
Responsibilities
Lead CMC regulatory strategy for investigational and early commercial biological products across global teams. Understand, interpret and advise on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biological products, to expedite submission, review and approval of global CMC applications.
Serve as a key strategic partner representing Global CMC Regulatory on cross-functional networks and matrix teams, advising R&D, supply, clinical trial supply, quality and commercial stakeholders.
Own submission content and ensure regulatory requirements for clinical trials, product release and stability are in place to avoid clinical holds and protect supply.
Participate in corporate evaluation and provide CMC regulatory support/advice to in‑licensing and divestment projects.
Involve in and lead current business‑critical activities across internal and external networks on behalf of GSK.
Identify regulatory risks and propose clear mitigation plans to senior leadership.
Support major inspections and quality incidents by producing regulatory strategy and managing regulatory interactions.
Mentor and develop regulatory colleagues, act as an individual contributor or may have direct line management responsibilities as per business needs.
Accountable for information submitted in marketing applications to meet regional requirements, allowing maximum manufacturing flexibility and innovation while ensuring approvability.
Ensure all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a third party are delivered to agreed timelines.
Problem Solving Skills
Direct project activities and strategies for multiple projects and teams simultaneously, including reporting staff if applicable. Provide strategic direction, data assessment and conclusions to senior management.
Formulate novel approaches and influence people, systems, and processes.
Identify key risks to the business associated with submission data and information packages and provide and communicate to senior management well defined risk mitigation strategies.
Create, maintain and continually evaluate/improve CMC Regulatory processes, policies, and systems.
Design and implement new and improved procedures to set standards and enhance the efficiency and quality of departmental work.
Qualifications
Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline.
Extensive CMC regulatory experience in biopharmaceuticals, including experience with development and manufacturing requirements.
Preferred Qualification
Advanced degree (MSc or PhD) in a relevant scientific discipline.
Experience leading CMC regulatory teams or line management responsibility.
Experience with lifecycle management and post‑approval regulatory activities.
Experience with cell and gene therapies, therapeutic proteins or other complex biologics.
Demonstrated success leading major inspections or regulatory interactions.
Practical experience with global regulatory frameworks and agency engagement.
Experience with mentoring junior colleagues.
Proven track record preparing or contributing to global CMC submissions.
Experience engaging with cross‑functional teams across R&D, supply and quality.
Strong written and verbal communication skills for interacting with internal stakeholders and regulatory authorities.
Ability to manage multiple projects, set priorities and meet timelines.
Working pattern and location This role can be based in the United Kingdom (Ware, Stevenage or HQ), United States (Upper Providence or Waltham), Belgium (Wavre), Italy (Siena) or Switzerland (Zug). The position is offered as a hybrid role with a balance of on‑site and remote working. Specific on‑site days will be agreed with your manager to support team collaboration and stakeholder engagement.
Benefits Salary ranges for this position vary by location (e.g., UK base salary ranges £75,000–£120,000, US base salary $173,250–$288,750), and include an annual bonus and eligibility to participate in a share‑based long‑term incentive program. Benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Equal Employment Opportunity GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information, military service or any basis prohibited under federal, state or local law.
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