We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

CMC Regulatory Affairs Manager

As a CMC Regulatory Affairs Manager, you will get the opportunity to be working with biologic products such as monoclonal antibodies and ADC's across all stages of product development, early to late clinical stages through to BLA (Biologics license application).

This is a global role collaborating cross-functionally with colleagues and stakeholders across drug development and CMC.

We are looking for this role to be based in any of the following locations: GSK HQ (UK), Ware (UK), Upper Providence (US) and Waltham (US).

In this role you will…

• Drive the CMC strategy and coordinate the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration submission content, in accordance with the applicable regulatory & scientific standards. 
• Manage project activities for multiple complex projects and teams simultaneously. Provides strategic direction, data assessment and conclusions within and across departments.
• Engages and may lead CMC Subject Matter Expert activities.
• May deliver CMC regulatory strategy to support major inspections (eg PAI's) or quality incidents.
• Have accountability for submission content. Understand, interpret and advise 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.  
• Formulate novel approaches and influence people, evaluating/improving CMC Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work.
• Direct and communicate complex regulatory issues independently across the company and with external agencies and third parties as necessary.
• May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects.

Why you?

Basic Qualifications:

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

• Extensive experience in pharmaceutical/biologics regulatory, or scientific disciplines.
• Demonstrates a broad and integrated knowledge of drug development and CMC activities.
• Demonstrated capability for business process analysis and optimization to deliver efficiency and / or greater compliance
• Ability to effectively communicate and influence key stakeholders beyond immediate department.
• Ability to translate complex concepts into actionable and measurable tasks.
• Ability to collaborate well with others and develop effective relationships, motivate and influence in a cross-functional environment beyond immediate department.

Preferred Qualifications: 

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

• Working knowledge of agile methodology, techniques, and frameworks, such as Scrum or Kanban, to deliver solutions.
• Previous experience of working with external partners.
• Ability to successfully manage matrix teams.
• Change management experience.
• Have previous experience working closely with or in commercial manufacturing, regulatory or quality function
• Experience delivering technology solutions to drive CMC operational efficiencies and/ or compliance.

Closing Date for Applications: Monday 26th August 2024

Please take a copy of the Job Description, as this will not be available post closure of the advert.
 When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

GSK R&D

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people o