Senior Regulatory Writer - Fully Remote in Ashton-under-Lyne

We are partnering with one of the world's leading healthcare communications organizations as they continue to expand their Regulatory Writing team. Due to ongoing growth, they are seeking experienced Senior Regulatory Medical Writers who are passionate about scientific excellence, client partnership, and delivering high-quality regulatory documentation across a diverse portfolio of pharmaceutical and biotechnology clients.

This is an opportunity to join a highly respected organization that values strategic thinking, collaboration, and long-term career development. The team is looking for individuals who want to make a meaningful impact, build strong client relationships, and contribute to the continued growth and evolution of the regulatory writing function.

The Opportunity:

As a Senior Regulatory Medical Writer, you will be responsible for developing and reviewing a range of regulatory documents while serving as a trusted scientific partner to both clients and internal stakeholders. You will work closely with multidisciplinary teams to ensure the delivery of clear, accurate, and compliant regulatory communications that support global development and submission strategies. This role offers exposure to a broad range of therapeutic areas and the opportunity to work directly with leading pharmaceutical and biotechnology companies.

Key Responsibilities

• Author, edit, and review a variety of regulatory documents for global pharmaceutical and biotechnology clients.
• Ensure all deliverables meet scientific, regulatory, and quality standards.
• Partner closely with clients to understand project objectives and provide strategic writing support.
• Collaborate with Regulatory Affairs, Clinical Development, Medical Affairs, Biostatistics, and project teams to deliver high-quality submissions.
• Manage multiple projects simultaneously while maintaining timelines and quality expectations.
• Contribute to client meetings and serve as a trusted scientific resource throughout project delivery.
• Support the development of best practices and contribute to the continued growth of the regulatory writing team.
• Stay informed of evolving regulatory guidance and industry developments.

Qualifications

• Advanced scientific degree preferred (PhD, PharmD, MD, MSc, or equivalent).
• Significant experience in regulatory medical writing within a pharmaceutical company, biotechnology organization, CRO, or healthcare communications agency.
• Strong experience authoring and reviewing regulatory documents for global submissions.
• Excellent scientific writing, communication, and stakeholder management skills.
• Ability to build strong relationships with clients and collaborate effectively across multidisciplinary teams.
• Strong project management and organizational skills with the ability to manage competing priorities.
• Experience within a client-facing environment is highly desirable.

Why Consider This Opportunity?

• Join a globally recognized healthcare communications organization with a strong reputation in regulatory and scientific communications.
• Work alongside industry-leading experts across a diverse portfolio of pharmaceutical and biotechnology clients.
• Be part of a growing team where your contributions will help shape future processes, capabilities, and client partnerships.
• Gain exposure to a wide range of therapeutic areas, products, and development programs.
• Excellent opportunities for professional growth, development, and career progression.

If you are an experienced regulatory writer looking to combine scientific excellence with strategic client engagement, we would welcome the opportunity to speak with you.