[M-41] | Manager | Regulatory Affairs

[M-41] | Manager | Regulatory Affairs

09 Sep
|
Knight Therapeutics
|
Canada

09 Sep

Knight Therapeutics

Canada

Position Summary

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.



Candidate Profile



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.

If you think you have what it takes, contact us at [email protected]

The original job offer can be found in Kit Job:
https://www.kitjob.ca/job/20518530/m-41-manager-regulatory-affairs-canada/?utm_source=html

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