Director, Regulatory Affairs
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The Director, Global Regulatory Affairs, is responsible for strategic direction of the RA function supporting the Pharmaceutical and Technologies Business Unit of Medication Delivery. The position will be responsible for providing regulatory guidance and oversight for key development programs that involve preclinical and clinical development components. Responsibilities include development of global regulatory strategic plans for two novel Top Programs (BTPs), providing regulatory leadership to multidiscipline project teams, submission management, and oversight of international registrations. The Director will be accountable for relationship and communication with FDA, as well as business management, international affiliates and development partners. 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 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 primary contact with the regulatory authorities including the planning and leadership of meetings |
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1. Sound basis of scientific knowledge, including expertise with clinical development 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. Higher degree/PhD will be an advantage. International experience/exposure preferred. Clinical development experience a must.
James Quirk HT Associates 847.577.0300 |
