Planet Pharma
Senior Associate, Publishing, Global Regulatory Operations
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Exciting Opportunity: Senior Associate, Publishing, Global Regulatory Operations (Remote - UK)
Are you passionate about ensuring life-changing medicines reach patients worldwide? Join our dynamic Global Regulatory Operations team as a Senior Associate in Publishing and play a vital role in delivering high-quality regulatory submissions that meet stringent global standards. This is a fantastic chance to contribute to innovative healthcare solutions within a collaborative, fast-paced environment.
In this pivotal role, you will:
- Prepare and execute timely, compliant regulatory documents for global health authorities, including the FDA, EMA, Health Canada, and ICH guidelines.
- Collaborate across cross-functional teams.
- Serve as a subject matter expert in regulatory publishing.
- Support our mission to bring innovative therapies to market efficiently and accurately.
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Required Skills
- 2-4 years’ experience in Regulatory Operations, with a solid background in creating and publishing eCTD regulatory submissions (IND, CTA, NDA, BLA, MAA)
- In-depth knowledge of global health authority regulations, guidelines, and specifications (FDA, EMA, Health Canada, ICH)
- Hands-on experience with industry-standard eCTD Publishing tools and eSubmission gateways, such as DXC ToolBox, GlobalSubmit, Lorenz, Starting Point templates, or Veeva Vault
- Strong communication skills, both written and verbal, with the ability to work independently and manage multiple projects simultaneously
- Attention to detail, problem-solving aptitude, and troubleshooting abilities
Nice To Have Skills
- Familiarity with Regulatory Information Management (RIM) systems like Veeva Vault or similar platforms
- Experience supporting regulatory initiatives or participating in cross-functional projects
- Knowledge of submission strategies and risk mitigation in a regulated environment
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Preferred Education And Experience
- Bachelor’s degree (BS/BA) or equivalent industry experience in a related discipline
- Prior experience supporting submissions for investigational and marketed products
Other Requirements
- This is a 12-month contract position, with a start targeted for November 2026
- The role is remote within the UK, requiring approximately 10% travel
- Clear understanding of compliance standards and good documentation practices
Take your regulatory publishing expertise to the next level and make a tangible impact on global healthcare. Apply now to join a pioneering team dedicated to innovation, compliance, and excellence in regulatory operations!
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