Director, Regulatory Affairs

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

📋 Description

• Provide support for global regulatory strategies, manage processes, and identify as well as address regulatory risks for assigned projects.

• Work collaboratively with cross-functional leaders to create and execute regulatory strategies in various jurisdictions.

• Plan and conduct thorough reviews of documents to ensure consistency and quality.

• Identify deficiencies in essential documentation to facilitate successful registration and lifecycle management.

• Foster relationships both within and outside the team, collaborating globally on regulatory strategies and activities throughout product development and post-approval stages.

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

• Oversee daily regulatory operations and manage multiple complex projects.

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

• Assist program leaders through Clinical Study Teams with clinical trial applications, marketing authorization applications, orphan drug designation applications, and pediatric submissions.

• Collaborate with strategic operations and other departments to provide regional regulatory insights.

• Act as the primary contact for Health Authorities and lead interactions with relevant authorities or external stakeholders.

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

• Stay updated with regulations and guidance documents, representing the regulatory function with leadership, ethics, and transparency.

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

• Collaborate with toxicology, pharmacology, and clinical development stakeholders to support IND-enabling and clinical-stage assets.

⛳️ Requirements

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

• Minimum of 8 years in Global Regulatory Affairs.

• Experience with major Health Authorities (US FDA, Health Canada, UK MHRA, and EMA) is essential.

• 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 grasp of regulatory strategy and implementation of operational activities.

• Excellent management, interpersonal, communication, negotiation, and problem-solving abilities.

• Demonstrated organizational awareness, including experience working across functions and on global teams.

🏝️ Benefits

• Eligibility for annual bonuses.

• Equity compensation opportunities.

• Comprehensive benefits package.

• Remote-friendly work arrangement, primarily allowing work from home.

• Occasional opportunities or expectations for travel to the London Office.

• Accommodations available upon request for candidates participating in all aspects of the selection process.