POSITION SUMMARY

The Director, Global Regulatory Affairs – International Region will play a significant role in providing International (ex‑North America) regulatory strategic leadership and execution for assigned clinical development and lifecycle management programs associated with rare diseases. This role will represent the regulatory function and provide guidance across internal R&D stakeholders and cross‑functional Program Teams, including Clinical Development, Clinical Operations, Biometrics, Nonclinical, Pharmacovigilance, Quality, Regulatory CMC, Regulatory Labelling, Regulatory Project Management, Medical Writing, corporate partners, and distributors, as applicable, across multiple countries.

The Director will act as the Regional Regulatory Lead for assigned projects and support Global Regulatory Project Team activities, ensuring International regulatory compliance and the timely delivery of submissions, approvals, and lifecycle management procedures. The scope includes, but is not limited to, high-quality regulatory submissions of original applications (i.e., NDAs, MAAs, INDs, etc.), clinical trial applications, rare disease designations, major supplements/variations, and lifecycle submissions for assigned programs in International markets, as applicable.

JOB FUNCTIONS/RESPONSIBILITIES

Regulatory Strategy and Leadership

• Develop and lead International regulatory strategies for assigned programs in alignment with global development and commercial objectives, under the guidance of senior Global Regulatory Affairs leadership.
• Serve as the Regional Regulatory Lead for assigned programs and represent International Regulatory Affairs on Program Teams and Global Regulatory Project Teams, as needed.
• Provide International regulatory guidance across the product lifecycle, including development strategy, country and regional requirements, submission planning, change control assessment, registration pathways, and lifecycle management.

Cross-functional Planning and Execution

• Contribute to Global Regulatory Project Team meetings in partnership with the Global Regulatory Lead and Regulatory Project Management, ensuring clear plans, timelines, risks, assumptions, decision points, and cross-functional alignment.
• Lead and/or oversee the preparation of regulatory documentation for Health Authority interactions, including meeting requests, briefing packages, clinical trial applications, marketing authorization applications, variations and amendments, and responses to Health Authority questions.
• Critically review submission documents to ensure scientific quality, regulatory compliance, consistency, and alignment with agreed International and global regulatory strategy.

Stakeholder Collaboration and External Engagement

• Partner with Regulatory Project Management, Regulatory CMC, Regulatory Labelling, Medical Writing, Clinical Operations, Clinical Development, Nonclinical, Pharmacovigilance, Quality, Biometrics, Commercial, and other cross-functional stakeholders to deliver timely, high-quality International regulatory outputs.
• Build and maintain effective relationships with international partners, distributors, local regulatory representatives, and external vendors to support submissions, approvals, and post-approval activities across International markets.
• Participate in Health Authority meetings and support preparation, negotiation strategy, meeting conduct, follow-up actions, and communication of outcomes to internal stakeholders.

Regulatory Operations and Compliance

• Contribute to and review responses to Health Authority questions to ensure they are appropriate, consistent, complete, and strategically aligned across International markets.
• Maintain current knowledge of EMA, EU, UK, Swiss, and other International regulatory requirements, guidance, and industry practices, while remaining aware of US FDA and Health Canada requirements that may affect global development strategy.
• Support major regulatory procedures and deliverables, including MAA-related activities, clinical trial applications, Pediatric Investigation Plans, Orphan Drug Designation activities, post-marketing commitments, variations and amendments, and lifecycle management activities, as applicable.
• Work with technical, medical writing, and cross-functional colleagues to support International product prioritization and special designation requests, where applicable, and ensure alignment with broader development strategy.

Communication and Team Support

• Clearly articulate regulatory challenges, risks, options, and potential solutions, and make practical recommendations to Global Regulatory Project Teams, Program Teams, International leadership, and senior management.
• Manage direct report(s), if applicable, and provide mentorship, coaching, and functional guidance to junior regulatory professionals.
• Support the Senior Director, Global Regulatory Affairs, and International Leadership Team activities, as required.

QUALIFICATIONS

Education /Experience:

Academic Background

• Bachelor’s degree in biological or life sciences, pharmacy, medicine, or a related scientific discipline, or an international equivalent.
• An advanced degree is preferred.

Industry and Regulatory Experience

• 10+ years of experience in the pharmaceutical industry, including 8–10 years in Global Regulatory Affairs.
• Deep understanding of drug development and substantial experience with international regulatory procedures and major Health Authorities.
• Proven experience developing and executing regulatory strategies for clinical development programs and marketed products, ideally in rare disease or specialty therapeutics.

Regulatory Scope and Submissions

• Strong understanding of EMA, EU, UK, Swiss, and broader international regulatory guidance, regulations, drug development processes, and industry practices.
• Working knowledge of US FDA and Health Canada requirements is preferred.
• Experience with major regulatory submissions and procedures—including clinical trial applications, MAAs, NDA/NDS support, Pediatric Investigation Plans, Orphan Drug Designation activities, variations and amendments, post-approval commitments, and lifecycle management activities—is preferred.

Strategic Leadership

• Experience in strategic problem-solving, Health Authority negotiations, and leading cross-functional teams on product regulatory strategy.

Knowledge, Skills and Abilities:

Communication and Judgement

• Ability to understand, synthesize, and communicate complex scientific and regulatory information clearly to support regulatory strategy and submissions.
• Excellent written and verbal communication skills, with strong personal integrity and sound judgment.
• Ability to clearly articulate regulatory challenges, identify potential solutions, and recommend pragmatic paths forward in emails, presentations, and team discussions.

Strategic and Regulatory Leadership

• Strong strategic problem-solving, negotiation, and decision-making skills.
• Demonstrated ability to lead decision-making within cross-functional teams.
• Ability to work independently, escalate key issues appropriately, influence senior stakeholders, set strategic direction, and navigate ambiguity.
• Experience across multiple phases of clinical development, including late-stage development and post-marketing activities, is preferred.

Collaboration and Influence

• Ability to build effective working relationships with internal stakeholders, Health Authorities, partners, distributors, local regulatory representatives, and external vendors.
• Demonstrated organizational awareness, including experience working cross-functionally, influencing without authority, and representing Regulatory Affairs on global teams.
• Proactive, collaborative, and solution-oriented, with strong organizational discipline.

Execution and People Leadership

• Excellent planning and organizational skills, with the ability to manage multiple projects, priorities, and tight timelines in a fast-paced environment.
• People management or mentoring experience is preferred, with the ability to provide clear direction, coaching, and feedback to team members.

WORK ENVIRONMENT

• This is a high‑growth, fast‑paced organization. The ability to be productive, collaborative, and team‑oriented is critical.
• Willingness and ability to travel domestically and internationally is required; anticipated travel is approximately 10–15% of work time.
• On‑site presence at the Basel office is required, with a minimum of 2 days per week unless otherwise agreed.

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