Senior Regulatory Affairs Associate (Health Canada expertise)

Ontario - Canada

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

Bring your expert knowledge of Health Canada regulatory requirements and guidelines to Parexel!

We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of Health Canada regulatory requirements and processes to a major dedicated client partnership.

As a Senior Regulatory Affairs Associate you will serve as the primary regulatory liaison with local health authorities (HAs) industry groups and internal this role you will lead regulatory processes ensure compliance with national legislation and provide critical support for product launches integrations and lifecycle management activities.

This is a dynamic position that demands deep regulatory expertise strong project management capabilities and the ability to effectively influence

crossfunctional teams in a fastchanging environment.

Key Responsibilities:

Documentation & Compliance

Prepare organize and coordinate local documentation (e.g. Module 1) to meet national submission requirements.

Maintain and update national systems in line with local legislation (renewals PSURs label updates CMC changes).

Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals.

Regulatory Submissions

Review prepare and submit dossiers; negotiate with HAs to secure approvals.

Provide local input for change control and post-approval requirements.

Collaborate with global functions to obtain documentation aligned with local requirements.

Audit & Inspection Support

Support RA representatives during audits/inspections ensuring readiness and timely CAPA closure.

Provide local expertise and responses to inspection queries.

Cross-Functional Collaboration

Partner with Regulatory Medical Marketing and Market Access teams to assess and mitigate impacts of regulatory changes.

Act as the primary RA representative for local Commercial and Medical teams translating business needs into actionable regulatory strategies.

Strategic Leadership

Lead regulatory strategies for product launches and integrations at the affiliate level.

Represent the company with local HAs industry groups and trade associations fostering positive relationships.

Provide critical support for promotional material review interpretation of regulations and implementation of local legislation.

Education

Bachelors degree in natural sciences (biology chemistry with pharmacological focus) or equivalent.

Advanced degree (Masters or PhD) preferred in law legal affairs or natural sciences.

Regional Regulatory Affairs Certification (RAC CARP CHPC) is a plus.

Experience

35 years of local regulatory knowledge and experience in a health authority-facing role.

Comprehensive understanding of regional and global regulatory requirements guidelines and processes.

Proven expertise in managing regulatory submissions timelines and cross-functional teams.

Strong project management and leadership skills.

Experience influencing Commercial Operations stakeholders and driving business-critical decisions.

Demonstrated ability to adapt and succeed in rapidly changing environments.

#LI-LB1

Required Experience:

Senior IC

When our values align theres no limit to what we can achieve.At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in...