Manager Regulatory Affairs

1 week ago

Canada Knight Therapeutics Full time

**Position Summary**

**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.
- **Analytical and Organisational Skills**
- **Negotiation skills / Teamwork**
- **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**
- **Dealing with Ambiguity**

**Required**

**Asset**

**Education**:

- B.Sc. in life science discipline or equivalent
- DESS in drug development
- M.Sc. in drug development

**Experience**:

- Strong scientific knowledge
- Strong knowledge of the Canadian regulations and good ability to interpret policies and guidelines
- Excellent communication skills, written and oral in English and French
- 3-5 years within the pharmaceutical industry, including managerial responsibilities
- Knowledge of international regulations
- Proficiency in Spanish or Portuguese (written and oral)

**Other**:

- Good knowledge of Microsoft Office Suite
- Project management tools

Why Knight?
Are you looking for a dynamic workplace where rapid decision making, entrepreneurial spirit and community are embedded in the DNA? Headquartered in Montreal, Canada, Knight Therapeutics is a fast-growing specialty pharmaceutical company focused on acquiring or licensing innovative pharmaceutical products for the Canadian and select international markets.

**BEWARE OF FAKE RECRUITERS. ONCE RECRUITED, KNIGHT THERAPEUTICS WILL NOT ASK YOU TO BUY YOURSELF YOUR WORK COMPUTER, OR OTHER EXPENSIVE WORK EQUIPMENT, TO BE SUBSEQUENTLY REIMBURSED BY KNIGHT. ALL VALID RECRUITMENT IS ALWAYS DONE BY EMAIL OR PHONE CALLS.**

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