Director, Regulatory Affairs
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Job Description
Regulatory Affairs Director guiding US and Canadian strategies, submissions, and FDA/Health Canada interactions for BeOne Medicines’ drug portfolio.
Responsibilities:
- Develop, implement, and advise on North America regulatory strategies for development programs
- Secure and maintain market access in North America in line with business objectives
- Coordinate with the global regulatory leader and key internal stakeholders
- Manage North American regulatory aspects of compounds through development, post-approval, and product lifecycle phases
- Provide leadership and strategic regulatory oversight for designated projects
- Interface with the FDA, Health Canada, and business partners regarding development, regulatory, and registration strategies
- Provide line management, people development, and performance management
- Support and lead development and implementation of department policies
- Provide regulatory strategic and operational direction and project mentorship
- Advise on clinical study requirements, marketing approval, strategic development plans, risk assessments, critical issues, and health authority interactions
- Oversee preparation and submission of investigational and marketing registration documentation in the US and Canada
- Review clinical trial and marketing application documents and amendments for US and Canadian requirements
- Liaise and negotiate with the FDA and Health Canada on drug development, regulatory issues, approvals, and labeling changes
- Monitor the global regulatory environment and assess impacts on business and product development programs
- Facilitate regulatory policy development and standard interpretation of global regulations
- Integrate functional expertise with business knowledge to solve problems and support business decisions
- Train, develop, and manage a regional regulatory team through direct and indirect reporting structures
- Build partnerships with senior stakeholders across functions
- Lead regulatory contributions to critical issues
- Assist with development and implementation of regulatory processes
- Recruit, develop, manage, and mentor regulatory professionals
- Create a goal-oriented culture
Requirements:
- 10+ years of experience in the biotechnical or pharmaceutical industry
- Minimum of 5 years’ experience in a Regulatory capacity with a broad background
- Bachelor’s degree required
- Experience working as a lead in Regulatory Affairs with the FDA preferred
- Prior experience with both small molecules and biologics preferred
- Thorough understanding of the drug development process, pharmaceutical industry, healthcare environment, regulatory requirements, and policy trends
- Extensive experience with INDs/CTAs, NDAs/BLAs, lifecycle management, Health Authority interactions, regulatory team leadership, and regulatory strategy development
- Proven track record of significant regulatory accomplishments
- Strong business acumen and sound decision-making ability
- Strong strategic skills, creativity, and ability to address strategic challenges
- Ability to deliver goals within a cross-functional team/partnership environment
- Excellent verbal and written communication skills
- Ability to analyze, define, and communicate complex issues persuasively
- Conflict resolution and negotiation skills
- Strong negotiating skills and ability to develop creative solutions
- Ability to build trust and respect within the organization
- Ability to prioritize and handle multiple projects simultaneously
- Experience with Microsoft Office suite
- Experience with Veeva regulatory publishing
- PowerPoint presentation authoring and presentation skills
- Ability to interact with external business partners and regulatory agencies
- Business travel availability of 10–20% as required
Benefits:
- Annual bonus plan eligibility for non-commercial roles
- Incentive compensation plan eligibility for commercial roles
- Discretionary equity awards
- Voluntary participation in the Employee Stock Purchase Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness benefits
- Equal opportunity employer
- Reasonable accommodation in the job application process
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