Job Description

378528 CMC Regulatory Affairs Manager

As a CMC Regulatory Affairs Manager, you will be a member of the CMC Small Molecules, Mature Products management team. In this team your primary focus will be the line management of a team of CMC regulatory professionals. These teams are responsible for lifecycle maintenance and network strategy activities for GSK\'s small molecules portfolio encompassing products aligned to classic and established, respiratory and HIV brands.

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

In this role you will

• Manage, or be responsible for, the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.
• Be responsible for the strategy development and oversight of meeting CMC regulatory deliverables to support uninterrupted supply of medicines through compliant Marketing Authorisations.
• Input CMC regulatory strategy to support major inspections or quality incidents.
• Understand, interpret and advise cross-functional teams on global regulations, guidelines, procedures and policies relating to CMC lifecycle changes and variations in relation to the manufacture of pharmaceutical products, to expedite submission, review and approval of global CMC regulatory applications.
• Work in cross-functional matrix project teams, which include colleagues from the wider regulatory organisation, quality and manufacturing.
• Maintain high quality standards and seek to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
• Influence your team member\xe2\x80\x99s professional development, building capabilities within the department.

Why you?

Basic Qualifications & Skills:

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

• BSc in Pharmacy, Chemistry or related scientific discipline or equivalent qualification
• Experience in authoring CMC dossier components
• Demonstrable track record leading and motivating others
• Demonstrated ability to lead cross-department initiatives with effective influencing skills
• Detailed knowledge of drug development and/or manufacturing and supply processes
• Detailed working knowledge of worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment
• Successful track record of managing multiple projects/teams simultaneously

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines
• Demonstrated ability to find innovative solutions to complex problems and involvement in continuous improvement initiatives
• Commercially astute and politically sensitive and able to manage sensitive and confidential issues
• Supervising and training junior staff
• Strong leadership skills
• Experience of evaluation and provision of CMC regulatory advice to in-licensing and divestment projects.

Closing Date for Applications \xe2\x80\x93 05th September 2023 (COB)

Please take a copy of the , as this will not be available post closure of the advert.

When applying for this role, please use the \xe2\x80\x98cover letter\xe2\x80\x99 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.

Why Us?

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organization 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\xe2\x80\x99s 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\xe2\x80\x99re 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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK\xe2\x80\x99s compliance to all federal and state US Transparency requirements. For more information, please visit GSK\xe2\x80\x99s Transparency Reporting site.

We\xe2\x80\x99re moving towards a more sustainable future with our new headquarters. With better public transport links and proximity to world-class science and technology institutions, we\xe2\x80\x99re excited for our move to the vicinity of Earnshaw Street, London WC1A (\xe2\x80\x9cthe New HQ\xe2\x80\x9d) by end H1 2024.

GlaxoSmithKline