Manager/Associate Director - Regulatory Affairs, Cmc

Job description Site Name: UK – London – New Oxford Street, Switzerland - Zug, UK - Hertfordshire - Stevenage Posted Date: Nov 25 2024   Are you interested in a highly visible regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios?
If so, this Regulatory Affairs CMC role could be an ideal opportunity to explore.
As a Regulatory Affairs Manager/Associate Director, you will be responsible for regulatory submissions, interactions, and strategy related to products within the UK.
Depending on candidate's experience we will offer Manager or Associate Director level role.
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 In this role you will Drive the CMC strategy, coordinate the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, ensuring compliance with evolving regulatory requirements.
Identify risks to the business associated with submission data and information packages and provide and communicate well defined risk mitigation strategies.
Mentor or train staff, manage project activities for multiple complex projects and teams simultaneously, and provide strategic direction, data assessment and conclusions within and across departments.
Engage CMC Subject Matter Expert activities, both internally (for increased compliance, harmonisation and efficiency) and externally (external advocacy and shaping the regulatory environment).
Deliver CMC regulatory strategy to support major inspections and quality incidents.
Ensure submission content complies with regulations, expediting review and approval of global CMC applications.
Identify risks to the business associated with submission data and information packages and provide and communicate well defined risk mitigation strategies.
Formulate and communicate novel approaches to improve CMC regulatory processes, policies, and systems, while managing complex regulatory issues independently.
Rapidly and appropriately communicates sensitive matters or those with potential for high business impact.
Why you?
Basic Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: Bachelor's Degree in Life Sciences or related discipline Experience in drug development and manufacturing and supply processes and may have a specialised area of expertise.
Experience with complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.
Proven project management and multi-tasking skills.
Developing experience in major filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development.)
Preferred Qualifications & Skills: Please note the following skills are not necessary, just preferred, if you do not have them, please still apply: PhD in Life Sciences or related discipline Pharmaceutical and/or vaccines product development experience Proven leadership experience in Regulatory Affairs within the pharmaceutical industry or research organizations.
Continued professional growth in global regulatory affairs, including communication of emerging trends and policies.
Recognised as a CMC Regulatory expert in a specific subject area.
Highly developed interpersonal, presentation, and communication skills, with established internal and external networks.
Typically has significant experience managing agency interactions Experience with ADC (Antibody-Drug Conjugates) Experience with Veeva systems Closing Date for Applications – 09 Dec 2024 (COB 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.
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: Our approach to R&D .
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.
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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).
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If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
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