Regulatory Writer and Publisher
Regulatory Writer and Publisher
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Job Description
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 youll 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 Catalents ethical standards and commitment to quality
The Candidate:
- A bachelors 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 Catalents global network. Benefit from a subscription to LinkedIn Learning providing access to 10000 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 Catalents 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 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.
Employment Type
Full-Time
