Regulatory Data and Content Professional (Senior Medical Writer)

• Job Title: Content Strategist – Regulatory Affairs
• Location: Mississauga, ON (Hybrid – 3 days onsite)
• Duration: Contract

• About the Role
• We are seeking an experienced Content Strategist to support regulatory submissions for pharmaceutical products. The successful candidate will lead content strategy, coordinate cross-functional document development, and ensure high-quality regulatory documentation for global health authorities.

• Key Responsibilities
• Lead content strategy for regulatory submissions and clinical documentation.
• Coordinate cross-functional teams to develop and review regulatory documents.
• Develop timelines and manage document authoring through submission.
• Ensure compliance with GxP, GCP, ICH, GVP, ISO, and applicable regulatory requirements.
• Review documents for scientific accuracy, consistency, and quality.
• Drive continuous process improvements and support global regulatory initiatives.

• Required Qualifications
• Bachelor's degree in Life Sciences or a related field.
• 5+ years of pharmaceutical or biotechnology regulatory experience.
• Strong experience with clinical, safety, or device regulatory documentation.
• Knowledge of global drug/device development and regulatory guidelines (GxP, GCP, ICH, GVP, ISO, MDR/IVDR).
• Experience leading cross-functional teams and managing regulatory content projects.
• Excellent written and verbal communication skills.
• Experience with Microsoft Office, Google Workspace, Adobe Acrobat, and Veeva Vault.

• Preferred Qualifications
• Experience supporting global regulatory submissions.
• Medical writing or regulatory content strategy experience.
• Ability to mentor junior team members.

• Work Arrangement
• Hybrid role requiring 3 days per week onsite in Mississauga, Ontario.

Apply today if you have strong pharmaceutical regulatory documentation experience and are passionate about supporting global regulatory submissions.