Regulatory Affairs Project Manager

About the role

Provide regulatory expertise and project management oversight to ensure timely delivery of projects in compliance with applicable regulations and client requirements Author, lead, manage, and review regulatory submissions, including INDs, IMPDs, BLAs, MAAs, agency responses, and lifecycle management activities Support US FDA and EU EMA/national authority submissions, with a focus on biologics and cell & gene therapy products Liaise with regulatory authorities and support health authority interactions, including Scientific Advice and Pre-Filing meetings Develop and implement regulatory strategies, assessing the impact of changes to processes, procedures, and products Build and maintain strong client relationships, acting as a trusted advisor and primary point of contact Represent Regulatory Affairs in internal, client, and agency meetings, effectively communicating at technical, scientific, and business levels Manage project deliverables, timelines, budgets, and financial performance in line with contractual commitments Contribute to business growth through identifying opportunities, supporting proposals, and assisting in resource planning Promote a "right first time" culture, ensuring adherence to quality standards, compliance, and continuous improvement Mentor and support junior team members, sharing knowledge and contributing to team development Prepare clear, high-quality technical documents, reports, and presentations, while sharing regulatory updates across the organisation The Candidate Bachelor's or Master's degree in a scientific discipline Extensive experience in biologics, cell & gene therapy (CGT), or ATMPs Strong knowledge of US FDA and EU EMA regulatory frameworks Proven experience preparing and managing regulatory submissions (eCTD experience essential) Excellent organisational skills and strong attention to detail Strong written and verbal communication skills with the ability to influence stakeholders Proficiency in Microsoft Word, Excel, and PowerPoint Self-motivated, proactive, and a strong team player Ability to work under pressure, managing multiple priorities and deadlines Strong problem-solving skills with the ability to work independently Why Join Catalent? Competitive Salary - Reflecting your skills and experience Bonus & Benefits - Annual performance bonus, pension scheme, life assurance, generous holiday entitlement (with option to purchase more), plus discounts via Reward Gateway Career Development - Access to training, mentoring, and cross-functional opportunities across Catalent's global network. Includes LinkedIn Learning subscription with 10,000+ courses Health & Wellbeing - Employee assistance programme, on-site canteen, Cycle to Work Scheme, Electric Vehicle scheme, and a strong "Patient First" safety culture. Join Employee Resource Groups and take part in charitable activities Excellent Location - Just two minutes from J16 of the M4 with free on-site parking Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. personal initiative. dynamic pace. meaningful work. Visit Catalent Careers to explore career opportunities. Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be pr

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Additional Information

Regulatory Affairs Project Manager Location: Swindon Position summary; Monday - Friday; 09.00 - 17.00 onsite. The Regulatory Affairs function ensures the organisation remains compliant with all applicable regulations and legislation, while actively engaging with federal, state, and local regulatory authorities. This role also provides strategic guidance on regulatory requirements and the evolving regulatory landscape impacting business activities. As a Regulatory Affairs Project Manager, you will combine scientific, regulatory, and business expertise to support the development, manufacture, and distribution of compliant products. You will act as a recognised subject matter expert within the department, contributing to team success through knowledge sharing and leadership.

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