Sanofi

Biopharma

Head,RegulatoryAffairs,GeneralMedicineandVaccinesCanada

CA$158–208k Toronto, Ontario, Canada FULL TIME
The Brief

“Head, Regulatory Affairs, General Medicine and Vaccines Canada at Sanofi. Skills: Regulatory Affairs, Team Leadership, Health Canada Submissions. Provide leadership to regulatory professionals. Manage regulatory affairs activities”

What You'll Achieve.

Achieve shortest time to approval; Obtain best possible labelling

Industry & Context.

Biopharma
Problems you'll solve

Risk analysis

What They're Looking For.

Must Have

Minimum Bachelor’s degree in science, Degree in a health-related field, At least 5 years of experience in regulatory affairs, Extensive knowledge of the regulatory environment

What You'll Do.

Provide leadership to regulatory professionals

Manage regulatory affairs activities

Oversee early approvals

Ensure regulatory compliance

Manage product lifecycle

Prepare regulatory dossiers

Submit regulatory dossiers to Health Canada

Respond to authority questions

Maintain commitments for product approvals

Evaluate business development opportunities

Assess regulatory strategy

Provide strategic direction

Ensure smooth daily operations

Develop scientific skills

Maintain awareness of regulatory trends

Review Health Canada guidelines

Provide comments on Health Canada policies

Implement departmental vision

Set individual priorities and goals

Provide constructive feedback

Provide coaching to direct reports

Facilitate employee development plans

Complete performance reviews

Implement personal development plan

How You'll Work.

Team & Collaboration

Business Unit leadership teams; RA Leadership team; Key corporate regulatory sites; Key opinion leaders; Industry advocacy groups

Process & Methodology

Project management

Free ATS check

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