Associate Director, Regulatory Affairs
Mississauga Ontario Canada
Responsibilities include, but are not limited to: Strategy 1. Contributes to global regulatory strategies through global regulatory strategy leader 2. Responsible for the creation & implementation of Canadian regulatory development & submission strategies for project & lifecycle management which is consistent with Canadian business objectives 3. May interface with global on Canadian regulatory strategy & implementation plans 4. Adjusts the Canadian regulatory strategy & implementation plan when new information including data, competitive landscape etc becomes available. 5. Proactively conducts local and global research in the therapeutic area to understand current and future market conditions. Develops understanding of positioning on new products, and creates the strategy to ensure an approvable dossier is presented to Health Canada. Ultimately responsible for assembling the dossier and negotiating product monograph. 6. Proactively assesses the pros, cons, & risks associated with Canadian strategic options for the product & communicates those issues to the global regulatory strategy leader & to local management 7. Coordinates & leads project related interactions with Health Canada on assigned products 8. Provides insight & recommendations on Health Canada guidance to global and local management 9. Contributes to development of regulatory promotional strategies consistent with commercial strategic objectives & supports adjustment of these strategies as required on assigned products 10. Strategic advisor (for the Regulatory / Compliance functions) to TAT or launch teams 11. Champion Celgene Values. Tasks 1. Complies with & reinforces compliance with Company SOPs & Work Instructions 2. Responsibility for Canadian regulatory goals & leads the implementation of the Canadian regulatory development & submissions strategy & life cycle management (for assigned products), ensuring global therapeutic alignment. 3. Responsible for commitments & license maintenance activities for assigned products 4. Identifies & communicates regulatory resource needs to functional management 5. Responsible for preparation, review and approval of all assigned Canadian submissions 6. Responsible for communication of regulatory project objectives & progress to local functional management and global regulatory affairs. Prioritizes and manages multiple projects and deliverables. 7. Contributes to the review of all Canadian advertising & promotion for assigned products 8. Participation in Canadian launch team and / or TAT as a Core Team Member, ensuring regulatory strategies are geared to meet TAT needs.
Skills/Knowledge Required: Experience 1. Bachelors degree in clinical or biological sciences discipline; 2. At least 8 years pharmaceutical industry experience with at least 5 years in Regulatory Affairs, with direct experience working with TPD. 3. Experience in hematology/oncology therapeutic areas Functional Skills • Demonstrated strong accountability skills, ability to operate in a team environment effectively • Proven understanding of therapeutic area & clinical endpoints for projects assigned • Expert level knowledge of Health Canada guidance and an in-depth understanding of the structure and workings of Health Canada. Proven success in development, implementation and execution of regulatory strategy, along with exceptional medical writing skills. • Proven influencing skills at all levels of the organization & with Health Canada • Proven success in leading scientific advice or other regulatory agency meetings • Experienced & effective leadership of successful CTAs, NDSs, S/NDSs, NCs • Represents functional team to the rest of the company Competencies 1. Thinks Strategically 2. Planning 3. Influencing Others 4. Manages Disagreements 5. Negotiating 6. Uses Technical/Functional Expertise 7. Analysis of Issues 8. Innovation Domestic and occasional International travel may be necessary
Deadline: 10 January 2014