Director, CMC Regulatory Affairs

Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Position Summary You will lead global Chemistry, Manufacturing and Controls (CMC) regulatory strategy for complex biological products. You will work across R&D, supply, quality and commercial teams to enable development, approval and uninterrupted supply. We value clear decision makers who build strong partnerships, solve problems with practical solutions, and support the growth of colleagues. This role offers visible impact, professional growth, and the chance to help GSK unite science, technology and talent to get ahead of disease together. Responsibilities This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following: Lead CMC regulatory strategy for investigational and early commercial biological products across global teams. Understands, interprets and advises on regulations, guidelines, procedures, policies and strategies relating to development, registration and manufacturing of biological products, to expedite submission, review and approval of global CMC applications. Serve as a key strategic partner representing Global CMC Regulatory on cross-functional networks and matrix teams, advising R&D, supply, clinical trial supply, quality and commercial stakeholders. Own submission content and ensure regulatory requirements for clinical trials, product release and stability are in place to avoid clinical holds and protect supply. May participate in corporate evaluation and provide CMC regulatory support/advice to in-licensing and divestment projects. Likely to be involved in and lead current, business critical activities across internal and external networks on behalf of GSK. Identify regulatory risks and propose clear mitigation plans to senior leadership. Support major inspections and quality incidents by producing regulatory strategy and managing regulatory interactions. Mentor and develop regulatory colleagues, act as an individual contributor or may have direct line management responsibilities as per business needs. Has accountability for information submitted in marketing applications to meet regional requirements, allowing maximum manufacturing flexibility and innovation while ensuring approvability. Ensures all appropriate CMC regulatory aspects across teams to support change control requests including transfer of supply within GSK or with a 3rd party are delivered to agreed timelines. Problem Solving skills Directs project activities and strategies for multiple projects and teams simultaneously, including reporting staff if applicable. Provides strategic direction, data assessment and conclusions to senior management. Formulates novel approaches and influences people, systems, and processes. Identifies key risks to the business associated with submission data and information packages and provides and communicates to senior management well defined risk mitigation strategies. Creates, maintains and continually evaluates/improves CMC Regulatory processes, policies, and systems. Key individual in designing and/or implementing new and improved procedures to set standards and enhance the efficiency and quality of departmental work. Qualifications Basic Qualification We are seeking professionals with the following required skills and qualifications to help us achieve our goals Degree in biological sciences, chemistry, pharmacy, engineering or a related scientific discipline. Extensive CMC regulatory experience in biopharmaceuticals, including experience with development and manufacturing requirements. Preferred Qualification If you have the following characteristics, it would be a plus Advanced degree (MSc or PhD) in a relevant scientific discipline. Experience leading CMC regulatory teams or line management responsibility. Experience with lifecycle management and post-approval regulatory activities. Experience with cell and gene therapies, therapeutic proteins or other complex biologics. Demonstrated success leading major inspections or regulatory interactions. Practical experience with global regulatory frameworks and agency engagement. Experience with mentoring junior colleagues Proven track record preparing or contributing to global CMC submissions. Experience engaging with cross-functional teams across R&D, supply and quality. Strong written and verbal communication skills for interacting with internal stakeholders and regulatory authorities. Ability to manage multiple projects, set priorities and meet timelines. Working pattern and location This role can be based in the United Kingdom (Ware, Stevenage or HQ), United States (UP or Waltham), Belgium (Wavre), Italy (Siena) or Switzerland (Zug). The position is offered as a hybrid role with a balance of on-site and remote working. Specific on-site days will be agreed with your manager to support team collaboration and stakeholder engagement. How to apply We would welcome your application. Please include a short cover letter or summary that explains how your experience fits this role and why you are interested. We are committed to inclusion and will consider reasonable adjustments to support you during the application process. Apply today and help us move science forward to make a real difference for patients. • If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $173,250 to $288,750. The US salary ranges take into account a number of factors including work location within the US market, the candidate skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process. Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people. GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. 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 at [email protected] where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide. Click the link where you will find answers to multiple questions we receive 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. 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For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/ We are 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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it 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. Find out more on our career site.