Executive Director, Regulatory Affairs

Work Requirement

This role will be based out of our San Francisco office and is hybrid with a minimum of 3 days per week onsite. 

Key Responsibilities

• Provides high level strategic and operational regulatory leadership and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Regulatory Agency Interactions.
• Builds, grows and manages a high-functioning team with a focus on staff development and appropriate succession planning. Provides leadership, coaching and feedback; mentors and empowers personnel.
• Uses extensive knowledge of US, EU, APAC and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate strategy.
• Oversees the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensure timelines are met.
• Reviews sections of IND/CTA, BLA/MAA, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
• Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite product approvals and labeling.
• Maintains awareness of the global regulatory environment and assess the impact of changes on business and product development programs. Facilitates policy and development of the standard interpretation of global regulation.
• Integrates functional expertise with business knowledge to solve problems and make good decisions to support overall corporate business strategy.
• Trains, develops and manages an effective regulatory team both via direct and indirect reporting structure.
• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of appropriate resources.
• Manages the preparation of operating and personnel budgets and plans. Authorizes expenditures, oversees forecasting activities and communicates anticipated variances to senior management as required.
• Responsible for assisting with the development, implementation and enforcement of regulatory processes.
   

Qualifications and Experience

• Ph.D. and 10+ years of work experience in pharmaceutical regulatory affairs, or B.S/M.S. and 12+ years of work experience in biotech or pharmaceutical regulatory affairs
• Preferred candidates will have experience working as a senior leader in Regulatory Affairs across two or more major geographic areas and prior experience with both small molecules and biologics.

Core Competencies, Knowledge and Skill Requirements:

• Proven interpersonal skills with the ability and experience to work collaboratively as a member of a global cross-functional team, working in multiple time zones.  
• Ability to establish and maintain effective working relationships. 
• Strong leadership skills with the proven ability to manage, develop and empower employees.
• Thorough understanding of drug development processes and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends.
• Extensive regulatory experience with INDs/CTAs, BLAs/MAAs, lifecycle management, interactions with Regulatory Agencies, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
• Strong business acumen and ability to make sound decisions that contribute positively to the business strategy or interests.
• Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.

Communication & Interpersonal Skills:

• Excellent verbal and written skills; Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders.
• Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
• Strong negotiating skills and ability to think creatively and develop creative solutions.
• Ability to prioritize and handle multiple projects.
• Proven ability to build trust and respect within the organization.
• Ability to interact with external business partners and Regulatory Agencies.