Mgr, Regulatory Affairs Pharma - HealthCanada

This is a fully remote position.

This person should be a subject matter expert on Regulatory Affairs as it relates to HealthCanada.


* Provides regulatory input to facilitate the timely preparation and submission of the required information to applicable agencies specializing in Canadian regulatory affairs.


* Manage the company's pharmaceutical products with a specialty in Canadian Regulatory Affairs.


* Facilitates regulatory strategy development and other compliant alternatives for the product team to register products globally, focusing on Canada.


* Offer guidance to departments on how to design, develop, evaluate, and market products in Canada.


* Authoring, reviewing, and coordinating quality submissions to regulatory agencies (Health Canada)


* Extensive knowledge of applicable government regulations with a focus on Canada.

PURPOSE AND SCOPE:

Ensure overall (other than auditing responsibilities) regulatory compliance for FMCNA pharmaceutical product.

Provides regulatory input to facilities in the preparation and timely submission of required information to applicable agencies.

Manages Regulatory Pharmaceuticals staff to develop expertise in the interpretation and application of appropriate regulations.

Responds to FDA or district office requests.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Manage the company’s pharmaceutical products and the associated RA staff.

Serves as a regulatory representative on Product Development Teams and provide regulatory support and advice for the team.

Responsibilities include:


* Facilitates regulatory strategy development and other compliant alternatives to product team.


* Facilitates clinical strategy development in providing regulatory guidance and intelligence on acceptable approval strategies.


* Assists in the short and long term schedule planning for the Product Team.


* Authoring, reviewing and coordinating quality submissions to regulatory agencies for viable product strategies and product submission.


* Assists in interactions with the FDA and other regulatory agencies.


* Builds professional relationships with the FDA project managers and other key personnel.


* Provides strong leadership and support within the department.

Provides coaching and counseling and advice to direct report employees.

Provides feedback to employees on a consistent basis.

Works with employees to develop clear and concise development plans to ensure the advancement of future talent.


* Responsible for the annual assessment for all direct report employees, utilizing the company’s performance management tools.


* Ensures FDA commitments are met in a timely manner.


* Provides regulatory review, feedback and /or approval for relevant documents, including advertising and promotional materials.


* Arranges and prepares for meetings, teleconferences, and other communications with the FDA (including read-ahead packages and/or other necessary documentation)...