Director, Regulatory Affairs

This is a fully remote position, open to applicants in United States, +3 more locations.

📋 Description

• Assist in the development of a global regulatory strategy, oversee associated processes, and identify and manage regulatory risks for designated programs.

• Collaborate with leaders from various functions to formulate and execute regulatory strategies across relevant jurisdictions.

• Evaluate documents for consistency and quality, identifying gaps in essential documentation.

• Foster relationships within and between teams in a global environment.

• Oversee regulatory strategy and activities throughout product development and post-approval in the EU, US, UK, and other relevant jurisdictions.

• Participate in global product team meetings, offering regulatory support and guidance.

• Manage day-to-day regulatory tasks and coordinate multiple complex projects.

• Develop and adhere to procedures for regulatory execution and implementation.

• Assist program leads through Clinical Study Teams for clinical trial applications, marketing authorization applications, orphan drug designations, pediatric submissions, and related activities.

• Collaborate with Strategic Operations, Clinical, Commercial, Medical Affairs, and other functions on regional regulatory planning.

• Act as a point of contact for Health Authorities, leading pertinent external interactions.

• Review and interpret regulatory guidelines, creating communication plans for impact assessments.

• Stay informed about regulations and guidance through meetings, conferences, journals, newsletters, and scientific literature.

• Lead the development of regulatory strategies for designated programs while reporting to the Vice President of Regulatory.

⛳️ Requirements

• At least 10 years of experience in the pharmaceutical industry.

• A minimum of 8 years in Global Regulatory Affairs.

• Proven experience with major Health Authorities, including US FDA, Health Canada, UK MHRA, and EMA.

• At least 8 years of experience with regulatory submissions, including INDs, NDA/NDS/MAA, post-marketing measures, PIP/PSP, ODD, BTD, and EU PRIME activities.

• Strong knowledge of regulatory strategy and the implementation of operational activities.

• Exceptional management, interpersonal, communication, negotiation, and problem-solving skills.

• Demonstrated organizational awareness.

• Experience working collaboratively across functions and on global teams.

• Experience in oncology, rare diseases, and immunology & inflammation is desirable.

🏝️ Benefits

• Eligibility for annual bonuses.

• Equity compensation.

• Comprehensive benefits package.

• Flexible remote work arrangement.

• Majority of work conducted from home.

• Occasional travel opportunities or requirements to the Salt Lake City headquarters or other office locations.