Regulatory Affairs Project Manager

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.

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 Bachelors or Masters 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 Catalents global network.

Includes LinkedIn Learning subscription with 10000 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 7000 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 .

This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written signed search agreement will become the sole property of Catalent.

No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Required Experience: IC Employment Type : Full-Time Experience: years Vacancy: 1

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