Senior Regulatory Strategy Associate

This is a fully remote position, open to applicants in Canada.

📋 Description

• Develop and propose regulatory strategies for assigned products, studies, or markets.

• Assist in planning agency engagements and prepare materials for regulatory meetings.

• Identify significant regulatory risks and opportunities to guide development strategies.

• Ensure regulatory strategies align with development and commercialization goals.

• Keep up-to-date with regulatory requirements and industry guidelines.

• Work collaboratively with cross-functional teams to maintain regulatory compliance and strategic coherence.

• Prepare necessary regulatory documentation and submissions.

• Monitor regulatory timelines and milestones to aid in program execution.

⛳️ Requirements

• Bachelor’s degree in life sciences, regulatory affairs, pharmacy, or a related discipline, or equivalent professional experience.

• Over 4 years of experience in regulatory affairs, clinical development, or a similar field.

• Prior experience with vaccine and/or biologic products is mandatory.

• Expertise/knowledge of FDA regulations is essential.

• Understanding of ICH-GCP, regulatory requirements, and clinical trial procedures.

• Familiarity with regulatory databases or submission tracking systems.

• Excellent communication, organizational, and problem-solving abilities.

• Experience in regulatory affairs, clinical development, or a regulated environment.

• Capacity to collaborate across teams and communicate effectively with both internal and external stakeholders.

• Patient-oriented mindset with a keen eye for detail.

• Proficiency in working with regulatory databases, submission tracking systems, and standard office tools.

• Advanced degree in regulatory affairs, pharmacy, or a related field is preferred.

• Experience with other global markets is a plus.

• Familiarity with regulatory submission software or electronic tracking systems is preferred.

• Experience in supporting FDA or international regulatory submissions is preferred.

🏝️ Benefits

• Flexibility to work remotely.

• Opportunities for continuous learning.

• Career development and skill enhancement within regulatory affairs and clinical development.

• A flexible, growth-oriented work environment.