Director, Global Regulatory Project and Submission Management

BeiGene

7d • $176,000 - $236,000

About The Position

The Director, Global Regulatory Project Management is a senior strategic leader who supports, influences, translates, and executes oncology regulatory strategies across the global drug development lifecycle. The role combines regulatory expertise, project management, and organizational leadership to drive NDA/BLA/MAA submissions and cross-functional coordination across regions. The Director anticipates regulatory challenges, influences decisions, and advances process improvements to support on-time submissions and worldwide product market access.

The Director supports global regulatory strategy for development programs and advises Global and Regional Regulatory Leads on product development, submissions, and lifecycle management. The role leads complex regulatory submissions across regions, translating strategic direction into actionable plans and coordinating cross-functional activities, timelines, risks, and documentation. It also builds partnerships across functional and regional teams, works with regulatory authorities and internal stakeholders to resolve issues, mentors staff, and leads improvements to regulatory processes and policies.

Occasional domestic and international travel may be required according to project needs and organizational priorities. The position offers an annual base salary range of $176,000 to $236,000. Non-Commercial roles are eligible for an annual bonus plan; Commercial roles are eligible for an incentive compensation plan. Employees are eligible for discretionary equity awards and may voluntarily participate in the Employee Stock Purchase Plan. The company also offers medical, dental, vision, 401(k), FSA/HSA, life insurance, paid time off, and wellness benefits.

Requirements

• Bachelor’s degree in science or a related discipline.
• At least 10 years of experience in regulatory project management and regulatory submissions, including small molecules and biologics, with significant global exposure.
• Demonstrated strategic regulatory leadership and a track record of successful submissions and regulatory project-management accomplishments in multiple regions.
• Experience leading cross-functional and cross-regional teams and influencing senior stakeholders globally.
• Strong business acumen and strategic thinking, with the ability to integrate multiple sources of data for decision-making.
• Excellent verbal and written communication skills, including the ability to explain complex regulatory issues clearly to internal and external stakeholders worldwide.
• Conflict-resolution and negotiation skills, and the ability to foster open communication across cultures.
• Ability to balance multiple tasks, prioritize effectively, and meet deadlines across time zones and regions.
• Proficiency with project-management and document-management tools such as Smartsheets, MS Project, and Power BI.
• Advanced skills in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
• Ability to quickly learn and adapt to software platforms and digital collaboration tools.

Nice To Haves

• Advanced degree.
• PMP or similar certification.
• Experience with electronic document-management systems and regulatory submission platforms.

Responsibilities

• Support, translate, and implement global regulatory strategies for development programs across major regions, aligning them with business objectives and long-term vision.
• Advise the Global Regulatory Lead and Regulatory Regional Leads on global product development, submissions, and lifecycle management.
• Integrate regulatory expertise and project-management knowledge to solve complex problems and support organizational decisions globally.
• Monitor global regulatory environments, policy trends, and competitive landscapes; assess their impact and adapt strategies.
• Lead complex regulatory submissions, including IND/CTA and NDA/BLA/MAA submissions, across multiple regions and applicable regulatory requirements.
• Translate the Global Regulatory Lead’s strategic vision into actionable project plans and coordinate operational execution.
• Organize and facilitate global cross-functional meetings to plan and track submission activities and promote accountability and alignment.
• Identify risks, propose solutions, and manage critical issues related to global regulatory submissions and strategy.
• Oversee preparation and submission of documentation supporting investigational and marketing registration packages, meeting global timelines and quality standards.
• Build partnerships with senior stakeholders and cross-functional teams, including clinical, medical, safety, CMC, and commercial teams.
• Liaise and negotiate with cross-functional teams and regulatory authorities to expedite submission timelines and resolve regulatory issues.
• Mentor and develop junior and mid-level staff in project planning, regulatory processes, and professional development.
• Champion process optimization and improvement initiatives within global regulatory project management.
• Lead development and implementation of regulatory processes and policies across regions.

Benefits

• Annual bonus plan eligibility for Non-Commercial roles; incentive compensation plan eligibility for Commercial roles.
• Eligibility for discretionary equity awards and 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director