Tuesday, April 3, 2007

Senior Director of Regulatory Affairs - IL

Position Title:
Senior Director Regulatory Affairs
Deerfield, IL
The Director, Global Regulatory Affairs, is responsible for strategic direction of the RA function supporting the Global Business of the Medication Delivery Division for a company with an 80% market share in this space.This is a very key roll with responsibilities for strategic direction and performance of the RA function within multiple portfolios, regions, or business units including development, implementation and management of plans and standards. Accountable for relationship and communication with Regulatory Authorities. Accountable for regulatory strategy and vision across multiple businesses or divisions 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, SNDAs), in addition to oversight and support for all international registrations. The Director will be accountable for relationship and communication with FDA, as well as business management and international affiliates
.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 Baxter
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 Business Unit, representing Global Regulatory Affairs on the business management team
8) Develop and manage budget as appropriate
9) Act as primary contact with the regulatory authorities including the planning and leadership of meetings

Job Requirements
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. Demonstrated leadership skills
5. Proven negotiation skills and significant experience in interacting with regulatory authorities
6. Risk management and problem solving skills
7. Ability to lead, mentor, and develop others for future growth and development8. Demonstrated ability to manage and build relationships with colleagues and regulatory authorities
9. Established credibility with regulatory authorities


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

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