Senior Director, Global Regulatory Affairs – Biotech Unit

This is a fully remote position, open to applicants in United States.

📋 Description

• Contribute to the overall strategy of the partnership program and advance its vision and mission.

• Develop, implement, and provide guidance on global regulatory strategies for development programs.

• Manage the regulatory facets of assigned assets throughout development, post-approval, and the product lifecycle.

• Offer strategic and operational regulatory guidance and mentorship.

• Formulate regulatory strategic plans and conduct risk assessments.

• Address critical regulatory issues and advise on interactions with Health Authorities.

• Supervise the preparation and submission of investigational and marketing registration documents globally.

• Review IND/CTA, NDA/MAA/NDS, and other global submission documents and amendments.

• Collaborate and negotiate with global regulatory authorities on drug development, approvals, and labeling modifications.

• Monitor the global regulatory landscape and evaluate its implications for business and product development initiatives.

• Establish regulatory processes and assist in interpreting global regulations.

• Consult with the Advisory Committee and provide counsel to the Execution Unit.

• Facilitate timely and high-quality planning and execution of related clinical studies.

• Conduct regular study review meetings and communicate study status, objectives, and operational and quality KPIs.

• Promote a global perspective and consistency within Global Regulatory Affairs.

• Engage in discussions about company-wide standards, including their finalization and implementation.

• Perform additional duties as assigned.

⛳️ Requirements

• Bachelor’s degree is required; an advanced degree is preferred.

• A minimum of 12 years in the biotechnology or pharmaceutical sector.

• At least 5 years in a regulatory leadership role.

• Comprehensive background in oncology.

• In-depth knowledge of US, China, EU, and ICH regulatory standards.

• Experience leading Regulatory Affairs across two or more significant geographic regions.

• Proven experience in managing multiple FDA interactions for oncology products that led to Agency approval actions.

• Demonstrated ability in managerial roles, leadership, and cross-functional collaboration.

• Solid understanding of the drug development process, pharmaceutical industry, healthcare landscape, regulatory requirements, and policy trends.

• Extensive experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, and implementation of regulatory strategies.

• A proven track record of substantial regulatory achievements.

• Strong strategic skills, creativity, and capacity to tackle strategic challenges.

• Ability to reconcile short-term objectives with long-term vision.

• Demonstrated capability to achieve goals in a cross-functional team or partnership setting.

• Exceptional interpersonal skills and the ability to foster positive working relationships within the organization.

• Proficient in written and spoken English.

• Knowledge of Mandarin is a plus.

• Proficient in Microsoft Office Suite.

• Willingness to travel domestically and internationally, up to 20%.

🏝️ Benefits

• Eligibility for an annual bonus plan for non-commercial positions.

• Discretionary equity awards.

• Participation in the Voluntary Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) and Health Savings Account (HSA).

• Life insurance coverage.

• Paid Time Off (PTO).

• Wellness benefits.

• Reasonable accommodations during the job application process.