Senior Regulatory Writer – Fully Remote

Senior Regulatory Writer - Fully Remote focuses on review a variety of regulatory documents for global pharmaceutical and biotechnology clients.

What the role involves

• 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.
• Collaborate with Regulatory Affairs, Clinical Development, Medical Affairs, Biostatistics, and project teams to deliver high-quality submissions.
• Managing multiple projects simultaneously while maintaining timelines and quality expectations.
• Serve as a trusted scientific resource throughout project delivery.

Skills and requirements

• 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.
• Ability to build strong relationships with clients and collaborate effectively across multidisciplinary teams.