regulatory affairs jobs

Regulatory Affairs Associate – 12-month Secondment

Location: Swindon, UK

Position summary; Monday – Friday 37.5 per week (3 days onsite, 2 days remote)

As a Regulatory Associate, you will support the delivery of high‑quality regulatory projects, ensuring all activities meet agreed timelines, comply with applicable laws and regulations, and align with client expectations. You will contribute to the preparation of regulatory submissions, collaborate with regulatory authorities, and build strong working relationships with internal teams and external clients.

The Role:

• Support preparation and submission of regulatory dossiers in line with legislation and client requirements.
• Contribute to marketing authorisation applications (MAA, ANDA, NDA, BLA) for EU and US registrations.
• Assist in drafting responses to regulatory authority questions and objections.
• Support variations, renewals, and drug development plans with cross‑functional teams.
• Provide input for Advice and Pre‑Filing Meetings, including Scientific Advice preparation and follow‑up.
• Offer regulatory guidance to internal non‑regulatory teams.
• Maintain a “right‑first‑time” approach by following quality standards.
• Identify new regulatory or cross‑selling opportunities with existing clients.
• Demonstrate flexibility to meet business and project needs.
• Keep regulatory knowledge current through training and development.
• Contribute to a high‑performance culture and ensure training is documented.
• Share updates on new regulations, laws, and publications with relevant teams.
• Support internal teams as required.
• Use communication tools effectively to stay informed and resolve regulatory issues promptly.

The Candidate:

• Bachelor’s degree in a scientific discipline or equivalent technical knowledge.
• Strong organisational skills and exceptional attention to detail.
• Technical writing experience.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Knowledge of regulatory affairs.
• Demonstrates a strong work ethic and the ability to perform under pressure.

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 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.