Director, Regulatory Affairs

RenaudExec & Associates Inc.; Canada; On-site; CAD 80,000 - 120,000; Full time

Job summary

A leading regulatory consultancy in Canada is seeking an experienced professional for a senior regulatory affairs position. The ideal candidate will manage the global regulatory strategy, oversee the preparation of regulatory filings, and represent the company in interactions with Health Canada and the FDA. This role requires extensive experience in regulatory affairs and a strong knowledge of compliance requirements. Competitive compensation is offered.

Qualifications

• Extensive experience in regulatory affairs.
• Strong understanding of regulatory requirements for Health Canada and FDA.

Responsibilities

• Responsible for the formation of global regulatory strategy.
• Preparation and maintenance of regulatory filings.
• Representation on all Regulatory matters.
• Guidance for regulatory path for new licenses.

Job description

The candidate will be responsible for the formation of the global regulatory strategy involving the direction and management of resources and activities in the development and implementation of regulatory strategies leading to the rapid submission and approval of dossiers meeting the requirements of Health Canada and FDA and the needs of the company.

Main Responsibilities

• You will be responsible for the preparation, filing and maintenance of filings for CTAs/INDs ANDS, NDS, DINAs, Labelling standards, etc., according to existing guidelines and corporate objectives.
• As the most senior person in regulatory affairs, your role will also include representing company on all Regulatory matters with the various Regulatory Inspectorates including responding to Clarifaxes, Notice of Deficiency (NOD) and Notice of Non-Compliance (NON).
• You will be responsible in elucidating the Regulatory path for all new in-licensing and in house development programs.
• You will provide guidance and coaching to the Regulatory Affairs Associates on all Regulatory and Market Access matters.