Executive Director, Global Regulatory Portfolio Lead
About the role
The Executive Director, Global Regulatory Portfolio Lead will oversee global regulatory strategies, advise on regulatory requirements, and manage regulatory aspects of development programs to secure and maintain market access.
Responsibilities
- Develop and implement global regulatory strategies
- Evaluate and recommend regulatory strategy
- Manage regulatory aspects of compounds through all phases of development
- Provide strategic regulatory oversight for designated projects
- Prepare and review global regulatory documentation
- Negotiate with global regulatory authorities
- Support regional teams in negotiations with global regulatory authorities
- Manage critical issues in collaboration with regions
- Recruit, develop, and mentor regulatory professionals
- Build partnerships with key stakeholders
- Develop and implement regulatory processes
- Assist with the development and implementation of regulatory strategies
Requirements
- Bachelor’s degree in a related field with 14+ years of experience in the biotechnology or pharmaceutical industry, or Master’s degree with 10+ years of experience in Regulatory Affairs
- Experience working as a lead in Regulatory Affairs across two or more major geographic areas
- Thorough understanding of drug development process and regulatory requirements
- Experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, and interactions with Health Authorities
- Proven ability to deliver on goals within a cross-functional team/partnership environment
- Excellent interpersonal, oral, and written communication skills
- Skilled in conflict resolution and negotiation
- Ability to prioritize and handle multiple projects simultaneously
Qualifications
- BA/BS Degree with 14 plus years of experience in the biotechnical or pharmaceutical industry, and a minimum of 10 years’ experience in a Regulatory capacity
- Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with both small molecules and biologics
- Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
- Able to identify and proactively respond to emerging regulatory trends, anticipate future challenges and opportunities in strategy, and identify scientific and/or clinical advances that impact drug development and regulations
- Integrates market needs and prioritization into strategy development
Skills
- Extensive knowledge of global regulatory environment
- Strategic and operational regulatory direction and leadership
- Leadership and strategic regulatory oversight
- Global strategy development and execution
- Regulatory affairs departmental and cross-functional influence
- Advising and liaising with senior management and project teams
- Developing and implementing regulatory strategies
- Building partnerships with key stakeholders
- Managing critical issues in collaboration with regions
- Training, developing, and managing an effective regulatory team
- Recruiting, developing, and mentoring regulatory professionals
Benefits
BeOne offers a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. Employees have the opportunity to own shares of BeOne Medicines Ltd. stock through discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan.
Pay
$284,700.00 - $364,700.00 annually
Schedule
Must be willing to travel approximately 10-20%.
Company Information
BeOne is committed to fair and equitable compensation practices. The recruiter can share more about the specific salary range for a preferred location during the hiring process. BeOne is an equal opportunity employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law.