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.

- Solid 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.

📌 Senior Medical Writer (Mississauga)
🏢 Pharmaceutical
📍 Mississauga