Job description
The SVP, Regulatory Affairs will have regulatory oversight and responsibility for strategic development of our pipeline throughout the product lifecycle. This individual should possess a strong capability for entrepreneurial strategic thinking, collaboration, and flexibility with respect to developing non-traditional regulatory paths consistent with regulatory guidelines and regulations.
The SVP, RA will be responsible for developing and implementing global regulatory strategies, establishing and maintaining effective relationships with global regulatory agencies, and developing strong partnerships across R&D, Commercial, Manufacturing, and Quality.
The individual will also have responsibility for:
The SVP, RA will be responsible for developing and implementing global regulatory strategies, establishing and maintaining effective relationships with global regulatory agencies, and developing strong partnerships across R&D, Commercial, Manufacturing, and Quality.
The individual will also have responsibility for:
- Leading the Regulatory Affairs and Medical Writing department, developing and retaining talent, and mentoring employees across the organization
- Establishing and maintaining highly credible and progressive relationships with FDA, EMA and MHRA
- Providing senior management with risk assessments and mitigation strategies
- Enhancing and maintaining an organization which brings expert science, creativity, and innovation.
- Establishing a regulatory affairs capability that will enhance the effectiveness of partner relationships through communicating and presenting information with regards to in-licensing and out-licensing products.
- Interfacing with the quality and compliance groups to help establish and maintain systems to assure that research and development activities and commercial operations are compliant with all applicable regulations.
- Supporting any planned growth or change within the organization through communication of company vision and strategy, business process improvement, relationship building, critical staffing, and personnel growth and development.
- Advanced degree, Ph.D. or M.D. in a science field such as Biology, Chemistry, or Pharmaceutical sciences is preferred.
- 15-20 years of Pharmaceutical/Biotech experience, with at least 10 years’ Regulatory Affairs experience in small molecule drug development and registration activities is required.
- Senior-level management of an approved new drug from discovery to market launch.
- Proven strategic development capabilities related to novel drug development and commercial support activities.
- Strong therapeutic knowledge and experience (CNS and Neuropsychiatry preferred).
- An extensive background and excellent relationship in working with the FDA, EMA, MHRA and/or other regulatory agencies.
- Superior leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner.
- Strong oral and written communications, executive presence, time management, and team-oriented leadership skills are essential.
- Track record of successfully building the capabilities and careers of a team.