CMC Regulatory Affairs Manager
1 month ago
Posted Date: Aug
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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 over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.
Find out more:
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
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
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