Manager, Regulatory Affairs
Mississauga Ontario Canada
The Manager, Regulatory Affairs is a strategic leadership role, supporting the hematology and oncology portfolio, and reports directly to the Associate Director, Regulatory Affairs. Responsibilities include, but are not limited to: Strategy: 1. Provides input into Canadian regulatory development & submission strategies, timelines & life cycle management, as assigned 2. Provides advice on the regulatory environment & the requirements that must be met in order to obtain approval of a product for the desired uses in Canada, as assigned 3. Interface with global on Canadian regulatory strategy & implementation plans, as assigned 4. May coordinate specific project related interactions with Health Canada 5. Examines regulations, guidance & competitive landscape in relation to assigned tasks & provides feedback and recommendations to local management and global regulatory affairs as needed 6. May establish & lead a CTA / NDS / S/NDS / NC implementation plan on assigned products 7. Champion Celgene Values Tasks: 1. Complies with Company SOPs & Work Instructions 2. Understands Canadian regulatory precedents for projects 3. May lead regulatory submissions team for projects assigned 4. Responsible for implementing Canadian regulatory strategies as assigned 5. Manage project timelines & regulatory deliverables, communicating status to the Regional Regulatory Strategy Leader in the US and local Canadian management as assigned 6. Responsible for the preparation, compilation & assembly of submission documents, e.g. Product Monograph, briefing documents, scientific advice & regulatory responses, in collaboration with Canadian regulatory management 7. Performs QA checks on submission documents to ensure quality of the content & compliance with regulatory guidelines 8. Ensures that copies of regulatory documents, including submissions, contact reports & correspondence with regulatory agencies are archived. 9. Reviews clinical study labels to ensure compliance with Canadian requirements 10. May participate on a TAT or product launch team as a Core Team Member 11. May perform advertising and promotional review of materials related to assigned projects under the supervision of Canadian regulatory management.
Skills/Knowledge Required: Experience 1. Bachelor’s degree in clinical or scientific discipline. 2. Preferably at least 2 years regulatory experience with at least 5 years pharmaceutical industry experience Functional Skills 1. Demonstrated strong accountability skills 2. Dedicated to creating Raving Fans 3. Ability to Review & Critique Data Originating in Other Functional Groups 4. Strong Analytical Skills, i.e. Able To Research Topics & Extrapolate Critical Information 5. Strong Attention to Detail 6. Good Understanding Of Drug Development & Clinical Trials 7. Understand The Product Lifecycle 8. Understand Health Canada requirements 9. In-Depth Knowledge of Health Canada Processes Competencies 1. Manages Execution 2. Builds Relationships 3. Listens to Others 4. Prepares written Communications 5. Drive for Results 6. Shows Work Commitment 7. Works Efficiently 8. Demonstrates Adaptability Domestic and occasional North American travel may be necessary.
Deadline: 10 January 2014