Associate Director, Regulatory Affairs – Regulatory Intelligence

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

📋 Description

• Oversee and evaluate global regulatory landscapes for modifications in laws, regulations, and guidance impacting drug and device development.

• Monitor and assess updates from regulatory bodies, industry associations, and external intelligence sources.

• Enhance and maintain regulatory intelligence databases and tools.

• Analyze regulatory trends and evaluate their effects on internal processes, development initiatives, and regulatory strategies.

• Provide prompt regulatory updates and actionable insights to stakeholders.

• Collaborate with Quality on change-control processes resulting from regulatory alterations.

• Simplify complex regulatory information into clear, actionable insights.

• Create and distribute newsletters, alerts, trackers, and periodic reports.

• Address internal inquiries with customized regulatory intelligence summaries and analyses.

• Facilitate regulatory intelligence meetings, training sessions, and forums for knowledge sharing.

• Coordinate discussions across functions with Quality, Pharmacovigilance, Clinical, CMC, and Regulatory Affairs.

• Lead public-commenting initiatives and assist with company submissions to regulatory agencies and industry organizations.

• Organize schedules for regulatory meetings, workshops, and conferences.

• Enhance regulatory intelligence processes, systems, tools, SOPs, and workflows.

• Oversee internal knowledge-management platforms, including SharePoint, intranet, and the Global Regulatory Affairs Portal.

• Contribute regulatory intelligence expertise to cross-functional projects and organizational initiatives.

• Manage the onboarding and offboarding of team members while providing leadership, coaching, and daily oversight for direct reports.

⛳️ Requirements

• A Bachelor's degree in life sciences, law, public policy, or a related discipline.

• At least 8 years of experience in pharmaceutical regulatory affairs, with a minimum of 6 years in regulatory intelligence.

• Strong working knowledge of drug, biologic, and device development processes, along with laws, regulations, and guidelines from FDA, EMA, PMDA, ICH, etc.

• Familiarity with the priorities of major regional and global industry associations, including PhRMA, EFPIA, and JPMA.

• Proficient in utilizing regulatory intelligence tools and databases.

• Excellent analytical, critical-thinking, problem-solving, and decision-making abilities.

• Capability to work independently with minimal supervision as well as collaboratively within a team.

• Attention to detail and an ability to manage multiple priorities effectively.

• A Master's degree or higher is preferred.

• Prior interactions with the FDA or other health authorities are advantageous.

🏝️ Benefits

• Annual performance-based bonuses.

• Equity-based incentive program.

• Generous vacation policy.

• Paid wellness days.

• Support for learning and development opportunities.

• Hybrid and remote work arrangements.