Your new company
An innovative and rapidly growing biotechnology organisation is seeking a Senior Manager, Regulatory Medical Writing, to join its expanding development team. Operating within a highly collaborative and science-driven environment, the company is focused on advancing a diverse pipeline of therapies through clinical development and regulatory approval.
Your new role
As Senior Manager, Regulatory Medical Writing, you will lead the development of high-quality regulatory documents across the product life cycle, supporting submissions from early clinical development through to marketing applications. You will work closely with cross-functional teams including Regulatory Affairs, Clinical Development, Medical Affairs, Pharmacovigilance, and Translational Medicine to ensure scientific accuracy, consistency of messaging, and regulatory compliance. You will also coordinate external medical writing resources and contribute to regulatory strategy discussions.
What you'll need to succeed
- Proven experience within Regulatory or Medical Writing in the pharmaceutical or biotechnology industry.
- Strong experience authoring Clinical Study Reports (CSRs), Clinical Protocols, Investigator Brochures (IBs), and Health Authority Briefing Documents.
- Knowledge of global regulatory requirements and submission processes.
- Experience supporting IND, CTA, BLA, MAA and eCTD submissions.
- Excellent communication, organisational, and stakeholder management skills.
- Ability to manage multiple projects and deliver against challenging timelines.
- Advanced degree in a life sciences discipline preferred (MSc, PharmD, PhD, MD, or equivalent).
- Extensive experience working cross functionally with US stakeholders
NO SPONSORSHIPS PROVIDED, RIGHT TO WORK NECESSARY
What you'll get in return
- The opportunity to work on innovative therapies with global impact.
- Exposure to a broad range of regulatory activities and strategic initiatives.
- A collaborative and supportive environment that encourages professional growth and development.
- The chance to play a key role within a growing and ambitious organisation.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
Senior Regulatory Writer in Oxford employer: Hays Specialist Recruitment Limited Careers
Hays Education is an exceptional employer, offering a supportive and collaborative work environment for SEN SLD/PMLD teachers in the Hounslow/Hillingdon area. With access to exclusive vacancies, ongoing professional development, and a dedicated consultant to guide your career, you will find ample opportunities for growth while making a meaningful impact on the lives of pupils with special educational needs. Join us to be part of a community that values inclusivity and fosters both personal and professional development.
Contact Details:
Hays Specialist Recruitment Limited Careers Recruitment Team
