Gan & Lee Pharmaceuticals · 2 months ago
Senior Director, Regulatory Affairs
United States
Full-time
Remote
Director/Executive
15+ years expGan & Lee Pharmaceuticals is seeking a Senior Director of Global Regulatory Affairs to provide strategic regulatory leadership. This role involves developing and executing U.S. and EU regulatory strategies and ensuring compliance throughout the product lifecycle.
BiopharmaBiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Develop and implement comprehensive U.S. and EU regulatory strategies within cross-functional development and asset teams
Lead or actively participate in cross-functional teams, including CMOs, global regulatory teams, submission teams, and product development teams, to ensure compliance with applicable U.S. and EU regulatory requirements
Provide expert guidance to internal stakeholders on complex regulatory issues and ensure alignment between regional and global regulatory strategies
Assess regulatory risks, propose mitigation strategies, and communicate key regulatory opportunities and challenges to senior management
Contribute to corporate strategic planning by providing regulatory insight and direction aligned with long-term business objectives
Oversee the preparation, review, and submission of key regulatory filings, including INDs, IMPDs, Scientific Advice requests, MAAs, and related correspondence with ICH-member health authorities
Drive submission coordination and lead strategy development for new product filings in the U.S. and EU
Establish and maintain standard operating procedures (SOPs) to ensure regulatory efficiency and effective cross-departmental collaboration
Monitor and interpret evolving regulatory guidelines; develop and deliver internal training sessions to keep relevant functions up to date
Represent the company in interactions with health authorities, industry associations, and external partners as a senior spokesperson
Oversee external consultants and regulatory collaborators to ensure high-quality deliverables and alignment with company goals
(Preferred) Leverage bilingual communication skills (Chinese and English) to:
Review and prepare IND/NDA/BLA/MAA dossiers (particularly CMC modules) based on Chinese source documents
Clearly communicate U.S./EU regulatory requirements in English to Chinese-speaking colleagues
Facilitate knowledge sharing between U.S. and China teams
Mentor and train junior regulatory staff in Beijing on regulatory science and best practices
Qualification
Required
Bachelor's degree in scientific discipline required
Minimum of 15 years of progressive experience in regulatory affairs within the pharmaceutical, biotechnology, or CRO industries
Proven leadership in developing regulatory strategies for investigational and marketed products, including IND/CTA, BLA, and MAA submissions
Deep understanding of U.S. and EU regulatory frameworks, particularly for biologics, biosimilars, oncology, and drug-device combination products
Extensive experience with GLP/GCP/GMP standards, clinical laboratory regulations, and licensing procedures
Demonstrated experience managing interactions with major health authorities (FDA, EMA, MHRA, etc.), including leading Scientific Advice and procedural communications (CHMP/CAT/PRAC)
Hands-on experience with Biological License and Marketing Authorization preparation, submission, and approval is required
Proven leadership and people management skills within matrix organizations
Strong ability to manage multiple complex projects concurrently
Strategic thinker with excellent analytical, problem-solving, and decision-making capabilities
Effective communicator with strong interpersonal and influencing skills
Excellent command of written and spoken English
Advanced proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Project)
Self-motivated, ethical, collaborative, and committed to organizational excellence and mission
Preferred
Advanced degree (MS, PhD, PharmD) strongly preferred
Regulatory Affairs Certification (RAC) or equivalent credential preferred
Leverage bilingual communication skills (Chinese and English) to: Review and prepare IND/NDA/BLA/MAA dossiers (particularly CMC modules) based on Chinese source documents, Clearly communicate U.S./EU regulatory requirements in English to Chinese-speaking colleagues, Facilitate knowledge sharing between U.S. and China teams, Mentor and train junior regulatory staff in Beijing on regulatory science and best practices
Experience working in multicultural and multinational environments strongly preferred
Chinese language proficiency is a plus
Company
Gan & Lee Pharmaceuticals
Founded in 1998, Gan & Lee Pharmaceuticals has successfully developed the first Chinese domestic insulin analog.
1001-5000 employees
H1B Sponsorship
Gan & Lee Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$46.46MKey Investors
Qiming Venture Partners
2020-06-28IPO
2015-01-01Private Equity
2012-02-01Series B
Leadership Team
Lawrence A. Hill
CEO Gan & Lee Pharmaceuticals USA
Recent News
BioWorld Financial Watch
2026-01-16
2026-01-03
Company data provided by crunchbase