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- Tasks: Compile and submit regulatory documents for global pharmaceutical projects.
- Company: Catalent is a leading global CDMO dedicated to improving health through innovative solutions.
- Benefits: Enjoy competitive salary, bonuses, private medical insurance, and generous holiday entitlement.
- Why this job: Join a dynamic team making a real impact in drug development and patient care.
- Qualifications: Bachelor's degree in a scientific discipline and strong technical writing skills required.
- Other info: Located near M4 with free parking; access to extensive training and career development.
The predicted salary is between 28800 - 48000 £ per year.
Catalent Swindon, England, United Kingdom
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Join to apply for the Regulatory Writer and Publisher role at Catalent
Catalent Swindon, England, United Kingdom
4 days ago Be among the first 25 applicants
Join to apply for the Regulatory Writer and Publisher role at Catalent
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) committed to helping people live better, healthier lives. We partner with pharmaceutical, biotech, and consumer health companies to support product development, launch, and full life-cycle supply. With over 40 global sites and thousands of scientists and technicians, Catalent delivers billions of doses of life-enhancing and life-saving treatments annually.
Catalent is looking for a talented Regulatory Affairs Publisher to support regulatory submissions and compliance across global projects. This role is pivotal in ensuring all documentation meets regulatory standards, client expectations, and project timelines.
The Role:
As a Regulatory Affairs Publisher, you\’ll play a key role in compiling, formatting, and submitting high-quality regulatory dossiers. Your responsibilities will include:
- Preparing and supporting regulatory submissions such as MAAs, ANDAs, and NDAs for both EU and US markets
- Managing variations, renewals, and Catalent-held DMFs
- Responding to regulatory authority queries and compiling responses to objections or questions
- Building and validating electronic submissions (e.g. INDs, Amendments, Supplements, PSURs, Annual Reports)
- Creating inter-document links, performing submission quality checks, and ensuring on-time electronic transmission
- Maintaining submission templates and documents in compliance with FDA, EMA, WHO, and ICH guidelines
- Providing regulatory insights to non-regulatory colleagues and supporting internal training efforts
- Contributing to the continuous improvement of internal systems, processes, and submission tools
- Attending internal meetings to represent Regulatory Affairs and foster strong client relationships
- Ensuring all work meets Catalent’s ethical standards and commitment to quality
The Candidate:
- A bachelor’s degree in a Scientific Discipline or equivalent technical experience
- Strong proficiency in Microsoft Word and Adobe Acrobat (Debenu preferred)
- Familiarity with electronic publishing tools and document management systems (preferred)
- Excellent technical writing skills and the ability to draft complex regulatory documentation
- A proactive approach to staying current on regulatory guidelines and sharing insights with colleagues
Why You Should Join Catalent:
- Competitive Salary – Reflecting your experience and skills.
- Bonus & Benefits – Includes an annual performance bonus, a pension scheme matching up to 8% and life assurance. Enjoy BUPA private medical insurance, a generous holiday entitlement that increases with tenure, and the option to purchase additional leave. Plus, gain access to Reward Gateway, offering discounts at many national retailers.
- Career Development – Access high-quality training, mentoring, and cross-functional opportunities within Catalent’s global network. Benefit from a subscription to LinkedIn Learning, providing access to 10,000+ online courses.
- Health & Wellbeing – Includes an employee assistance programme, on-site canteen facilities, and an active safety and “Patient First” culture. Take advantage of a Cycle to Work Scheme and an Electric Vehicle car scheme. Join Employee Resource Groups that foster a diverse and inclusive workplace. Plus, participate in charitable activities.
- Excellent Location – Just a two-minute drive from J16 of the M4, with free on-site parking.
We have been made aware of potential inaccurate job advertisements on third-party websites. Please consider Catalent’s Career Site as the trusted and accurate source of information for any jobs available with Catalent
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.
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Seniority level
Entry level
Employment type
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Employment type
Full-time
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Job function
Marketing, Public Relations, and Writing/Editing
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Industries
Biotechnology Research and Pharmaceutical Manufacturing
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Regulatory Writer and Publisher employer: Catalent
Contact Detail:
Catalent Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Writer and Publisher
✨Tip Number 1
Familiarise yourself with the specific regulatory guidelines relevant to the role, such as FDA, EMA, and ICH standards. This knowledge will not only help you in interviews but also demonstrate your commitment to staying current in the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who work at Catalent or similar companies. Engaging with them on platforms like LinkedIn can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss your experience with electronic publishing tools and document management systems during the interview. Highlight any specific projects where you successfully managed regulatory submissions, as this will showcase your practical skills.
✨Tip Number 4
Demonstrate your proactive approach by sharing examples of how you've kept up with changes in regulatory guidelines. This could include attending workshops, webinars, or completing relevant online courses, which shows your dedication to professional development.
We think you need these skills to ace Regulatory Writer and Publisher
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a Regulatory Writer and Publisher. Familiarise yourself with regulatory submissions like MAAs, ANDAs, and NDAs, as well as the specific requirements for EU and US markets.
Tailor Your CV: Highlight your relevant experience in regulatory affairs and technical writing. Emphasise your proficiency in Microsoft Word and Adobe Acrobat, and mention any familiarity with electronic publishing tools or document management systems.
Craft a Compelling Cover Letter: In your cover letter, express your passion for regulatory affairs and how your skills align with Catalent's mission. Mention specific examples of your past work that demonstrate your ability to compile and format regulatory documents effectively.
Proofread and Edit: Ensure that your application materials are free from errors. Given the nature of the role, attention to detail is crucial. Have someone else review your documents to catch any mistakes you might have missed.
How to prepare for a job interview at Catalent
✨Know Your Regulatory Standards
Familiarise yourself with the key regulatory guidelines such as FDA, EMA, WHO, and ICH. Being able to discuss these standards confidently will show your understanding of the role and its requirements.
✨Showcase Your Technical Writing Skills
Prepare examples of your previous work that demonstrate your technical writing abilities. Be ready to discuss how you approach drafting complex regulatory documents and any challenges you've faced in the past.
✨Be Proactive About Industry Trends
Stay updated on the latest developments in regulatory affairs. Mention any recent changes in regulations or guidelines during your interview to showcase your proactive approach and commitment to continuous learning.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about how you would handle regulatory queries or objections, and be prepared to explain your thought process clearly.
