The Director, Global Regulatory Affairs, is responsible for strategic direction of the RA function supporting the a Global Business Unit for one of our key clients in the pharmaceutical industry. The position will direct and manage a team of regulatory professionals responsible for development of global regulatory strategic plans for new product development as well as life cycle management of existing products. Responsibilities include management of all US submissions (INDs, NDAs, ANDAs, SNDAs), and oversight of international registrations. The Director will be accountable for relationship and communication with FDA, as well as business management and international affiliates.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Guide, direct, and lead a team of regulatory professionals in development of strategic plans and regulatory submissions
2. Foster and maintain relationships with regulatory authorities to facilitate interactions on behalf of our client
3. Ensure alignment of regulatory strategy to business strategy across all functional areas
4. Oversee development and negotiation of overall plans regarding safety, efficacy, and quality to assure viability for global or regional registrations
5. Accountable for ensuring that regulatory submissions meet appropriate standards and content requirements
6. Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
7. Act as business liaison to the Anesthesia Business Business Unit
8. Develop and manage budget as appropriate
9. Act as primary contact with the regulatory authorities including the planning and leadership of meetings
1. Sound basis of scientific knowledge
2. Expert knowledge of pharmaceutical regulations, standards, current industry practices, and strong experience with interpretation and application.
3. Excellent written and verbal communication, presentation, and facilitation skills
4. Proven negotiation skills and significant experience in interacting with regulatory authorities
5. Risk management and problem solving skills
6. Ability to lead, mentor, and develop others for future growth and development
7. Demonstrated ability to manage and build relationships with colleagues and regulatory authorities
8. Established credibility with regulatory authorities
EDUCATION AND EXPERIENCE
Advanced Degree or country equivalent in related scientific discipline with a minimum of 10 years experience in RA, including at least 5 years experience managing people. Higher degree/PhD will be an advantage. International experience/exposure preferred
If you have an interest in this position please send your resume and email expressing your interst to firstname.lastname@example.org or give me a call at 207-510-6666.