Senior Director, Regulatory Affairs
The Senior Director, Global Regulatory Affairs provides strategic regulatory leadership and direction across assigned development programs. This individual is responsible for developing and executing U.S. and EU regulatory strategies, ensuring successful interactions with health authorities, and driving compliance and regulatory excellence throughout the product lifecycle. Key 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.
- Bachelor’s degree in scientific discipline required; an advanced degree (MS, PhD, PharmD) strongly preferred.
- Regulatory Affairs Certification (RAC) or equivalent credential preferred.
- 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.
- Experience working in multicultural and multinational environments strongly preferred.
- 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; Chinese language proficiency is a plus.
- Advanced proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Project).
- Self-motivated, ethical, collaborative, and committed to organizational excellence and mission.
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