Vice President Global Regulatory Affairs
TITLE: Vice President, Global Regulatory Affairs
Location: Gaithersburg, MD
Background: Our client is a Global clinical-stage biopharmaceutical company, which is in the process of expanding its US team in Gaithersburg, Maryland.
Reporting to the Chief Medical Officer, this is an exciting opportunity to lead the Global Regulatory Affairs Function. The Vice President and Head, Global Regulatory Affairs will have ownership of all global, regional and local Regulatory Affairs functions, including supervisory responsibility for all regional Regulatory Affairs employees reporting into this role. This individual will develop and execute the Company’s global regulatory strategy for all Research & Development ("R&D") and commercial products; develop and guide CMC regulatory strategy; oversee compliance; and serve as a true business partner to Company leadership. S/he will maintain and further upgrade the core competencies of the Regulatory Affairs ("RA") organization from a technical, commercial and people perspective, which includes establishing organizational commitment and a sense of urgency to drive leading projects through all development stages.
- Provide regulatory strategic leadership for all drug development projects, including but not limited, to health authority submissions, interactions and other regulatory requirements in line with corporate objectives and timelines
- Provide leadership, and when necessary, contribute hands on support to the regulatory team in managing, planning, coordinating, and preparing all documents submitted to FDA and ex-US health authorities in support of INDs, BLAs, MAAs, DMFs, CTAs, amendments, safety reports, and annual updates
- Develop budgets and resource forecasts for the Regulatory Team.
- Lead all interactions with regulatory agencies
- Contributes to the strategic leadership and development of policies, procedures and best practices commensurate with the requirements of a rapidly growing company
- Minimum of 15 years’ experience with increasing responsibilities in global regulatory affairs and compliance and management of healthcare product development, of which at least ten (10) years shall have been in a senior role, interacting to affect direction and decision-making within development programs and in regulatory agencies.
- Solid basis in scientific approach and an ability to deal with in depth technical information for a variety of disciplines and to foster a high degree of scientific credibility, both within the technical community inside the organization and with regulatory agencies.
- Strong strategist and operational leader; capable of getting the job done and dealing effectively with health authorities.
- International experience, including successful submission of product license applications and other dossiers with subsequent approval by regulatory authorities in relevant countries.
- Proven experience in developing systems for effective global submission, registration, approval and maintenance of complex class of medical devices; extensive knowledge of worldwide regulatory requirements for medical product development and registration.
- Strategic and technical expertise required to develop and guide execution of the Company's global regulatory strategy for CMC issues.
- Ability to design and build well-established Regulatory Affairs organization and serve as the face of this organization for the Company, working closely with global peers, interfacing across all functions and making an impact.
- Strategic thinker capable of executing on strategy across entire portfolio; demonstrated success in setting regulatory strategy and in obtaining worldwide product approvals, particularly those involving complex issues; ability to provide guidance to subordinates, peers and senior management on product development strategies through all stages of the product development cycle.
- Experience affecting direction and decision-making within development programs and regulatory agencies; successful track record of taking products through development and approval.
- Strong knowledge and experience with global regulatory affairs and regulations; demonstrated ability to develop and maintain excellent working relationships with U.S. and international health authorities and significant experience presenting to global regulatory authorities.
- Recognized expert in regulations, guidelines and precedents; a proactive driver of development through commercialization.
- Demonstrated ability to maintain positive and proactive collaborations cross-functionally with line functions; to bring about change and lead and mentor team members and serve as a champion for others’ success.
- Flexible, positive and creative thinker with the proven ability to develop and implement innovative programs and processes; competence in analysis and solving of problems and the ability to prioritize and make tradeoffs to achieve goals.
- Strong, organized leader who sets clear goals and standards of accountability.
- Superior leadership, management and organizational skills, and a reputation as an open, available and transparent communicator. Demonstrated ability to manage effectively, to encourage and implement effective lines of communication and control, and to lead and influence a multi-disciplinary team.
- Personal leadership qualities and interpersonal / communication skills which will instill confidence at large and amongst regulatory health authorities and other outside organizations.
- Team player, who understands that success is only possible in conjunction with departmental and cross-functional peers.
- Bachelor’s Degree in technical or technology related field required. Advanced degree in life sciences is preferred.
Travel will be required (up to 25%)