Senior Regulatory Strategy Associate

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

📋 Description

• Develop and propose regulatory pathways for designated products, studies, or markets.

• Assist in planning agency engagement and prepare materials for regulatory discussions.

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

• Ensure regulatory approaches are in harmony with development and commercialization goals.

• Keep abreast of current regulatory requirements and industry guidelines.

• Work collaboratively with cross-functional teams to ensure compliance and strategic alignment.

• Prepare necessary regulatory documentation and submissions.

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

• Contribute to regulatory strategy from the planning phase through implementation.

• Support regulatory strategy efforts that promote new treatments for patients.

⛳️ Requirements

• Strong skills in regulatory strategy, strategic thinking, and problem-solving.

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

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

• A patient-focused mindset and meticulous attention to detail.

• Proficiency in using regulatory databases, submission tracking systems, and standard office applications.

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

• 4+ years of experience in regulatory affairs, clinical development, or a related field.

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

• Expertise/knowledge of FDA regulations is essential.

• Familiarity with ICH-GCP, regulatory requirements, and clinical trial processes.

• Experience with regulatory databases or submission tracking systems.

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

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

• Experience in specific therapeutic areas or development phases is preferred.

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

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

🏝️ Benefits

• Remote work arrangement.

• Flexibility.

• Growth opportunities.

• Continuous learning opportunities.

• Career path exploration and skill expansion across regulatory affairs and clinical development.