Associate Director, Regulatory Affairs – Regulatory Intelligence

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

📋 Description

• Monitor, evaluate, and interpret global regulatory changes impacting drug and device development.

• Keep track of updates from regulatory bodies, industry associations, and external intelligence sources.

• Maintain and enhance databases and tools related to regulatory intelligence.

• Analyze regulatory guidance, policies, and regulations, and relay actionable insights to stakeholders.

• Collaborate with Quality on change control processes.

• Convert complex regulatory information into actionable insights.

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

• Deliver customized regulatory intelligence analyses for internal inquiries and decision-making.

• Facilitate regulatory intelligence meetings and forums for knowledge sharing.

• Coordinate cross-functional discussions with Quality, Pharmacovigilance, Clinical, CMC, and Regulatory Affairs teams.

• Oversee public commenting processes and assist with submissions to regulatory authorities and industry organizations.

• Manage information related to regulatory meetings, workshops, and conferences.

• Enhance regulatory intelligence processes, systems, tools, SOPs, and work practices.

• Administer internal knowledge platforms, including SharePoint, intranet, and the Global Regulatory Affairs Portal.

• Offer regulatory intelligence expertise for cross-functional initiatives and organizational projects.

• Oversee onboarding and offboarding processes, providing leadership, coaching, and daily oversight for direct reports.

⛳️ Requirements

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

• A Master's degree or higher is preferred.

• A minimum of 8 years of experience in pharmaceutical regulatory affairs, including 6 years focused on regulatory intelligence.

• Strong working knowledge of the development processes for drugs, biologics, and devices, along with applicable laws, regulations, and guidelines from FDA, EMA, PMDA, ICH, etc.

• Familiarity with key priorities of major regional and global industry associations, such as PhRMA, EFPIA, and JPMA.

• Proficient in regulatory intelligence tools and databases.

• Previous experience with FDA or other health authorities is advantageous.

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

• Ability to work both independently and collaboratively.

• High attention to detail with the capability to manage multiple priorities effectively.

• Strong communication skills, adaptability, ethical conduct, and a commitment to ongoing learning.

🏝️ Benefits

• Competitive salaries.

• 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 available.