Manager, Regulatory Affairs

Manager, Regulatory Affairs

14 Feb
|
Knight Therapeutics.
|
Montréal

14 Feb

Knight Therapeutics.

Montréal

Montréal, QC



Role



Reporting to the Director of Regulatory Affairs, the Manager will assume responsibilities within the Scientific Affairs department to ensure the timely approval and regulatory maintenance of pharmaceutical products in Canada and foreign countries, in collaboration with corporate partners. The ideal candidate is highly organized, has flexible and adaptable communications capabilities, demonstrate good problem-solving skills and can adapt to changing priorities.



This position is based in Montréal; French/English bilingualism, both written and oral, is required.



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.

- Elaborating internal processes for the development of the Regulatory Affairs’ department in collaboration with other Knight departments. Supervising the regulatory activities for the licensing and maintenance of pharmaceutical products marketed in Canada and foreign countries.

- Ensuring liaison and coordination with corporate partners and consultants for the preparation of quality regulatory dossiers, as well as during Health Canada review of the dossiers.

- Ensuring liaison with Health Canada for general regulatory matters and product specific issues, including meetings with the Agency.

- Elaborating regulatory strategies to support the company regulatory and business plans.Acting as the qualified person for regulatory affairs matters raised internally or by corporate partners.

- Supervision of employees in the Regulatory Affairs’ department.



Characteristics of a Good Candidate



Analytical and Organizational Skills

The candidate must have good analytical skills with a high-level of attention to detail and commitment to accuracy; able to handle multiple projects at a time.

Negotiation Skills / Teamwork

The candidate must have excellent interpersonal skills and demonstrate flexible and adaptable communications capabilities with partners inside and outside the country, and with regulatory authorities. She/he must be able to effectively function in a fast-paced, people-oriented, team environment.

Autonomy / Problem Solving

The candidate must work independently while interacting with various people. She/he must have the ability to identify important issues and to identify solutions in a timely manner.

Dealing with Ambiguity

The candidate must demonstrate adaptability in situations involving change and the ability to evaluate and properly adapt documents supplied by corporate partners for Canadian regulatory requirements.



Qualifications/Job Requirements



- Sc. in life science discipline or equivalent

- DESS in drug development

- Minimum of 3-5 years within the pharmaceutical industry; including personnel management

- Strong knowledge of the Canadian regulations and the proven ability to interpret policies and guidelines

- Strong clinical development scientific knowledge

- Excellent communication skills; written and oral French and English

- Strong knowledge of Microsoft Office Suite



Assets



- M.Sc. in drug development /regulatory affairs or clinical development

- Knowledge of international regulations



Benefits of working at Knight:



- Competitive salary and bonus plan

- Employee stock option plan

- Employee share purchase plan

- Flexible group insurance plan

- Registered retirement savings plan



Please send your CV to [email protected]



Only selected candidates will be contacted.

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