Directeur(rice) associé(e), Affaires réglementaires - Oncologie clinique/ Associate Director, Regulatory Affairs - Clinical Oncology

MSD•Kirkland, QC

10d•Hybrid

About The Position

The Associate Director Clinical Oncology reports to the Director Clinical, Regulatory Affairs and is responsible for engaging and supervising Clinical Specialists/Senior Specialists that are assigned oncology projects and creating a virtual team environment without disrupting the structure. The Associate Director is assigned a portfolio of oncology products. The Associate Director has shared responsibility for the development of the employees, operational improvements/efficiencies and assigned critical projects. This role may evolve to include people-manager responsibilities. The incumbent will complete their tasks in a manner fully consistent with The Company’s commitment to its Code of conduct, Our Values and Standards, policies, procedures, industry standards and all Laws and Regulations. This includes the obligation to report all Adverse Events and Product Quality Complaints as per The Company policy, “Know to Report” Pharmacovigilance training, and Health Canada Regulations. Perform other activities as requested by the Director Clinical, Regulatory Affairs.

Requirements

Advanced University Degree, M.Sc. or higher in Health Sciences or equivalent.
Minimum 10 years’ experience in clinical regulatory affairs.
Completed New Drug Submission filings to Health Canada.
Strong communication and time management skills.
Ability to work independently with minimal supervision.
Strong collaboration and teaming skills balancing a functional role and department regulatory affairs management role.
Demonstrated knowledge and awareness of Health Canada Food and Drug Act and Regulations and ability to interpret.
Demonstrated knowledge and awareness of regulatory affairs science, concepts, terminology.
Knowledge of the local operating procedures.
Demonstrated understanding of company Global Regulatory Affairs organization, processes, compliance expectations.
Demonstrated understanding of Oncology business needs and strategy.
High level understanding and ability to interpret Health Canada Regulatory requirements and Guidance Documents that impact Clinical and compliance-related submissions.
Comprehensive understanding of the functioning of a pharmaceutical company, including the roles of other departments and how they interact with Regulatory Affairs.
Advanced ability to communicate effectively verbally and in writing with multiple stakeholder types (clinical, commercial, government).
Advanced presentation skills and ability to adapt presentations to various audiences.
French language is required (written and oral).
Excellent word processing, presentation & spreadsheet application skills.
Familiarity with the use of a large compliance databases.
Ability to learn new computer interface systems.
Visible commitment to the department and the company.
Strong ability to explain and defend decisions/positions and take positions in the best interest of the company.
Demonstrated Ethics and Integrity, without compromise to compliance.
Excellent time management, organizational & planning skills.
High level of accuracy & quality in work.
Excellent collaboration skills.
High Compliance mindset/focused.

Nice To Haves

Oncology expertise

Responsibilities

Leadership and oversight of Regulatory projects within the oncology portfolio including planning and assignment of projects.
Oversight and follow-up on key projects to be able to answer questions from and contribute to discussions with senior management.
Responsible for New Product Registrations and efficacy indications in Oncology, with advanced knowledge of the products, science and company strategy.
Responsible for key Regulatory submissions such as Priority Review / Notice of Compliance with conditions requests, product safety issues etc. with high knowledge and ability to intervene on behalf of the Department for these key Regulatory submissions.
Primary contact with Health Canada for oncology portfolio.
Primary contact with local stakeholders for oncology portfolio.
Primary contact with Global Regulatory Affairs for oncology programs and responsible for fostering a collaborative environment with a focus on continuous improvements in processes/efficiencies.
Canadian representative on the Global regulatory affairs meetings and collaborative global regulatory meetings.
Contribute to the overall functioning, structure, processes and change management, taking leadership in Department initiatives and responsible for outcome/success.
Complete tasks in a manner fully consistent with The Company’s commitment to its Code of conduct, Our Values and Standards, policies, procedures, industry standards and all Laws and Regulations, including the obligation to report all Adverse Events and Product Quality Complaints.
Perform other activities as requested by the Director Clinical, Regulatory Affairs.