Site Name: Italy - Siena, Belgium-Wavre, UK – London – New Oxford Street, USA - North Carolina - Durham Posted Date: Jan 7 2025 Director, Vaccine Mature Products, CMC Location: Siena, Italy / GSK HQ, UK / Wavre, Belgium / Poznan, Poland Directs key, strategic CMC regulatory activities in late development and/or the global lifecycle management of GSK products. Management oversight for a team ensuring compliance with GSK policies and procedures, staff development and training to deliver roles. Key Responsibilities include, but are not limited to: Represents Global CMC Regulatory, on Regulatory Networks and Matrix Teams providing and overseeing strategic direction and guidance to Supply Chain, Quality Assurance, 3rd Party Contract Management, Commercial and wider GRA on both global project and key strategic business initiatives. Identifies key risks to the business associated with submission strategy and information packages and provides and communicates to senior management well defined risk mitigation strategies. Likely to have direct line management responsibility. Coaches and mentors staff across CMC RA on lifecycle management in CMC. Responsible for managing budget and resource for their teams. Responsible for team compliance with GSK policies and procedures, staff development and training to deliver roles. Successfully navigates internal/external networks. Leads influences and motivates staff within and across departments. Commercially astute and organisationally aware and able to deal with sensitive and confidential issues. May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects. Delivers CMC regulatory strategy to support major inspections (e.g. PAI's) or quality incidents (LICs/PIRCs). Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of the company. Leads the company position to influence the internal/external CMC Regulatory environment through specialist areas of intelligence. Has accountability for submission content. Understands, interprets, and advises on regulations, guidelines, procedures, policies, and strategies relating to development, registration, and manufacturing of pharmaceutical products, to expedite submission, review, and approval of global CMC applications in alignment with regional requirements. Directs resources (across multiple projects and teams simultaneously) to ensure all appropriate CMC regulatory aspects across teams to support license maintenance and change control requests including transfer of supply within the company or with a 3rd party are delivered to agreed timelines. Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies, and systems to enhance the efficiency and quality of departmental work. Operates with independence. Directs and communicates complex regulatory issues independently at senior levels across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs ensuring optimum position for the company. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Able to demonstrate the following key high-performance behaviours, customer driven, flexible thinking, and continuous improvement Detailed knowledge of drug development and manufacturing and supply processes and may have a specialized area of expertise. Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment. Proven project management and multi-tasking skills. Track record of effective influencing and negotiating with regulatory agencies, industry bodies, and personnel within the company in a variety of settings. Demonstrated ability to handle complex global CMC issues through continuous change and improvement. Experience in leading major post-approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management) Preferred Qualifications: If you have the following characteristics, it would be a plus: Life cycle management experience ideally including previous roles within pharmaceutical and/or vaccines product support. Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Has identified opportunities to further educate colleagues and formulate approaches to most effectively meet new requirements. Identified as CMC Regulatory expert in a specific subject area. Proven experience in supervising and training staff within and across the organisation. Closing Date for Applications: 21st January 2025 (COB) 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 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. Why GSK? 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. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. 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’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.