Executive Director Regulatory Affairs - Biopharma

Posted 30 June 2024
Salary Negotiable
LocationCalifornia
Job type Full Time
Discipline Clinical & DataCRO & Clinical Operations
ReferenceBBBH1784_1719829078
Contact NameSiobhan Mcloughlin

Job description

Mantell Associates is currently partnered with a publicly listed clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization of next-generation, bispecific and multifunctional biotherapeutics, initially focused on the treatment of cancer. They are searching for an Executive Director of Regulatory Affairs to join their team.

Executive Director of Regulatory Affairs - Responsibilities:

  • Provide 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
  • Build, grow and manage a high-functioning team with a focus on staff development and appropriate succession planning. Provide leadership, coaching and feedback; mentors and empowers personnel
  • Use 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
  • Oversee the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensure timelines are met
  • Review sections of global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements
  • Liaise and negotiate 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
  • Maintain 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
  • Integrate functional expertise with business knowledge to solve problems and make good decisions to support overall corporate business strategy
  • Trains, develop and manage an effective regulatory team both via direct and indirect reporting structure
  • Build 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
  • Manage the preparation of operating and personnel budgets and plans. Authorize 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

Executive Director of Regulatory Affairs - Requirements:

  • PhD 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
  • 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
  • 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

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.