Manager, Regulatory Affairs

3 weeks ago

Montréal, Canada Knight Therapeutics Inc. Full time

**Role**

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

**Responsibilities**:
1. Preparing quality regulatory submissions according to Health Canada standards and predefined timelines for drugs, biologics and natural health products. This includes:
i. Evaluating the available data (chemistry/ manufacturing, clinical and pre-clinical, labelling);
ii. Preparation of CTD summaries, including Module 1, according to Canadian requirements;
iii. Preparation of responses to clarification requests according to the Agency’s deadlines.

2. Elaborating internal processes for the development of the Regulatory Affairs’ department in collaboration with other Knight departments.

3. Supervising the regulatory activities for the licensing and maintenance of pharmaceutical products marketed in Canada and foreign countries.

4.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.

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

6. Elaborating regulatory strategies to support the company regulatory and business plans.

7. Acting as the qualified person for regulatory affairs matters raised internally or by corporate partners.

8. Supervision of employees in the Regulatory Affairs’ department.

**Analytical and Organizational Skills**

**Negotiation Skills / Teamwork**

**Autonomy / Problem Solving**

**Dealing with Ambiguity**

**Qualifications/Job Requirements**
- B.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 share purchase plan
- Flexible group insurance plan
- Registered retirement savings plan

**Job Types**: Full-time, Permanent

**Salary**: $85,000.00-$110,000.00 per year

**Benefits**:

- Company events
- Dental care
- Disability insurance
- Employee stock purchase plan
- Extended health care
- Life insurance
- Paid time off
- RRSP match
- Vision care
- Work from home

Schedule:

- Monday to Friday

Supplemental pay types:

- Bonus pay

**Education**:

- Bachelor's Degree (preferred)

Work Location: In person

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