Gan & Lee Pharmaceuticals
Senior Director, Clinical Regulatory Affairs
Denmark - Full Time
Summary
The Senior Director, Clinical Regulatory Affairs will provide strategic leadership across clinical development programs, ensuring regulatory readiness from early-phase through pivotal trials. This individual will shape and execute clinical-focused regulatory strategies in U.S. and EU markets, support submission readiness for clinical trial applications (CTAs/INDs), and drive alignment across development functions and geographic regions.
Key Responsibilities
Education & Credentials
Experience
Skills & Competencies
The Senior Director, Clinical Regulatory Affairs will provide strategic leadership across clinical development programs, ensuring regulatory readiness from early-phase through pivotal trials. This individual will shape and execute clinical-focused regulatory strategies in U.S. and EU markets, support submission readiness for clinical trial applications (CTAs/INDs), and drive alignment across development functions and geographic regions.
- Lead development of regulatory strategies for clinical programs (Phase I-III) within cross-functional and global teams, ensuring clinical trial designs and regulatory filings in U.S. and EU are aligned with business and scientific objectives.
- Serve as regulatory lead for clinical submissions including INDs/CTAs, protocol amendments, investigator brochure updates, clinical trial notifications/variations, and interfacing with health authority clinical/regulatory review divisions.
- Provide regulatory guidance to clinical development teams, medical affairs, biostatistics, data management, and external partners on regulatory expectations for clinical programs including adaptive design, global trial harmonization, patient population considerations, and regulatory risk mitigation.
- Assess clinical-regulatory risks (e.g., trial design, endpoints, safety/efficacy balance) and develop mitigation strategies; communicate key regulatory insights and decision points to senior management.
- Oversee and coordinate clinical regulatory deliverables, such as CTA/IND dossier compiling, PIP/SPA briefing documents, health-authority meeting packages, and clinical-regulatory advice responses.
- Establish and maintain standard operating procedures (SOPs) and best practices for clinical regulatory operations, ensuring efficient cross-functional workflows, documentation control, and compliance with GCP/GMP/ICH guidelines.
- Monitor evolving regulatory guidelines in clinical development (U.S. FDA, EMA, other major regions), identify training needs, deliver internal training, and ensure regulatory intelligence is shared broadly.
- Represent the company in interactions with regulatory agencies, external stakeholders, and industry forums as required acting as senior regulatory spokesperson for clinical programs.
- Manage relationships with external clinical regulatory consultants and collaborators, ensuring effective delivery of services aligned with company priorities.
- Bachelor of Science in Life Sciences, Pharmacy, or related field required; advanced degree (MS, PhD, PharmD) preferred.
- Regulatory Affairs Certification (RAC) or equivalent preferred.
- Minimum 15 years of progressive regulatory experience in pharmaceuticals, biotechnology, or CROs, with substantial leadership responsibility in clinical regulatory affairs.
- Demonstrated track record leading regulatory strategy and submissions for clinical-stage products (IND/CTA, pivotal trials) in U.S. and/or EU.
- Deep familiarity with U.S. and EU regulatory frameworks for drugs and biologics in clinical development, including interactions on clinical design, endpoints, safety/efficacy considerations, and regulatory advice engagements.
- Expertise in global clinical trial execution: adaptive/innovative design, multi-regional trials (MRCTs), regulatory harmonization, protocol amendments, and health authority negotiations.
- Experience managing internal and external stakeholders in a matrix organization (clinical development, medical affairs, data/biostatistics, quality, CMC) and working in multi-culture/multi-country environment.
- Demonstrated leadership and ability to influence in a global matrix organization.
- Excellent strategic thinking, analytical skills, and decision-making capabilities.
- Strong project and people management skills, able to lead multiple complex clinical regulatory programs concurrently.
- Proficiency in Microsoft Office suite (Word, Excel, PowerPoint, Project).
- Highly self-motivated, ethical, collaborative, adaptable to change, and aligned with the organization’s vision and goals.
