Senior Vice President, Global Regulatory Affairs

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

📋 Description

• Formulate regulatory strategies for both US and global markets in alignment with business goals.

• Offer guidance, direction, and leadership on regulatory strategies to the development team and senior management.

• Contribute strategically to clinical development plans.

• Head the regulatory team in delivering expert advice to development teams while operationalizing key regulatory tasks.

• Recognize talent development opportunities and anticipate team capability requirements as the pipeline progresses.

• Organize meeting requests and briefing documents, coordinate and prepare teams for meetings, and act as the main liaison with regulatory authorities.

• Keep abreast of US and EU laws, regulations, guidelines, and the global regulatory landscape.

• Identify and collaborate with regulatory specialists and consultants.

• Coordinate and prepare responses to inquiries from regulatory authorities.

• Represent Regulatory Affairs on cross-functional development teams.

• Establish, revise, and implement regulatory policies, standards, and procedures.

• Lead global regulatory strategy throughout late-stage development, launch readiness, product registration, and post-approval lifecycle management.

• Collaborate with Commercial, Medical Affairs, Legal/Compliance, Quality, Pharmacovigilance, Supply Chain, and Market Access on launch readiness, compliant communications, labeling, and lifecycle planning.

• Ensure regulatory operations adhere to FDA, EU, ICH, EMA, and industry standards.

• Oversee regulatory aspects of products and projects, including timelines and deliverables.

• Guide electronic regulatory submissions and assist development teams in their preparation.

• Author, review, and edit informed consents, Investigator’s Brochures, study materials, essential documents, presentations, and reports.

• Collaborate with the designated EU Person to ensure compliance with Good Distribution Practices for API.

• Report directly to the Chief Medical Officer.

⛳️ Requirements

• Advanced degree preferred.

• Over 15 years of regulatory experience.

• At least 10 years of experience in a senior leadership role.

• Proven leadership skills in establishing clear direction and objectives; capable of simplifying complex processes and creating an environment that nurtures talent.

• Experience in leading a team of regulatory professionals and external partners, with a preference for guiding a team through phases of company growth.

• Excellent understanding of the drug development process and the regulatory environment in the USA, EU, and other regions.

• Demonstrated experience in directing regulatory strategy for late-stage, launch, and commercial-stage products in both US and international markets.

• Familiarity with post-approval regulatory activities, including labeling strategy, safety updates, CMC changes, post-approval commitments, renewals, and supplements/variations.

• Proven capability to advise executive and commercial leadership on regulatory risks impacting launch timing, market access, labeling, competitive positioning, promotional strategy, and lifecycle management.

• Ability to provide strong regulatory leadership within a cross-functional team.

• Advanced knowledge and experience in interpreting regulations, guidelines, and precedents related to drug development.

• Exceptional listening, communication, and interpersonal skills, with a history of promoting team collaboration and consistently delivering high-quality work.

• Ability to accurately forecast timelines and manage them across regulatory projects.

🏝️ Benefits

• Annual bonus.

• Long-term incentives.

• Health insurance.

• Dental and vision coverage.

• Term life and disability coverage.

• Retirement plans.

• Remote position.

• Travel required as needed to fulfill business requirements.