Description:
Reporting to the Director of Regulatory Affairs, the Manager will assume responsibilities within the Regulatory Affairs department to ensure the timely approval and regulatory maintenance of pharmaceutical products in Canada and at the international level, in collaboration with corporate partners. The ideal candidate is highly organised, has flexible and adaptable communications capabilities, demonstrate good problem solving skills and can adapt to changing priorities.
This is a full time position with a preference for Montreal-based candidate.
Specific Responsibilities
- Preparing quality regulatory submissions according to Health Canada standards and predefined timelines for drugs, biologics and natural health products. This includes:
- Evaluating the available data (chemistry/ manufacturing, clinical and pre-clinical, labelling);
- Preparation of CTD summaries, including Module 1, according to Canadian requirements;
- Preparation of responses to clarification requests according to the Agency’s deadlines.
Characteristics of a Good Candidate
- Analytical and Organisational Skills
The candidate must have good analytical skills with high-level attention to detail and commitment to accuracy and depth.
- Negotiation skills / Teamwork
The candidate must have good interpersonal skills and demonstrate flexible and adaptable communications capabilities with partners inside and outside the country, as well as with regulatory authorities. She/He must have the ability to motivate, lead, and grow a regulatory affairs team.
- Ability to Multitask
She/he must be able to effectively function in a fast-paced, people oriented, team environment where priorities may shift. She/he will be able to handle multiple projects at a time.
- Autonomy / Problem Solving
The candidate must work independently, yet interacting with various people. She/he must have the ability to identify important issues and identify solutions in a timely manner.
- Dealing with Ambiguity
The candidate must demonstrate adaptability in situations involving constant changes and an ability to evaluate and properly adapt the documents supplied by corporate partners for Canadian regulatory requirements.