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Senior Regulatory Affairs Specialist (Remote)

Remote:

Full Remote

Contract:

Fixed term

Salary:

96 - 96K yearly

Experience:

Senior (5-10 years)

Work from:

Canada

Offer summary

Qualifications:

Bachelor's degree in Regulatory Affairs, Life Sciences, or related fields, 5+ years of regulatory affairs experience, Understanding of Canadian regulations, Bilingualism for Health Canada documentation.

Key responsabilities:

Ownership of regulatory oversight from concept to post-market phases
Collaboration with cross-functional teams to ensure compliance
Management of regulatory aspects for various product categories
Overseeing facility registrations and staying updated on requirements
Communicating regulatory guidance to stakeholders

Quantum Management Services Ltd. Human Resources, Staffing & Recruiting SME https://www.quantum.ca/

201 - 500 Employees

See more Quantum Management Services Ltd. offers

Job description

Position: Senior Regulatory Affairs Specialist (Remote)

Location: Montreal – 100% Remote (you must be located at maximum 2 hours from the Montreal office)

Salary: 90K to 95K (16 paid days of vacation )

Job Type: 12-month contract (maternity leave replacement)

As a Regulatory Affairs professional, you'll take charge of regulatory responsibilities across various product categories, guiding them from ideation to approval and post-market phases. Your role involves seamless collaboration with cross-functional teams, ensuring compliance with regulations while thriving in an environment free of bureaucracy, enabling direct contributions and impactful decision-making.

Key Responsibilities

Take ownership of regulatory oversight from concept to post-market phases
Collaborate across R&D, quality, manufacturing, marketing, and sales teams to ensure regulatory compliance
Drive decision-making, navigate ambiguity, and solve regulatory challenges efficiently
Manage regulatory aspects for diverse product categories, including drugs, medical devices, and cosmetics
Oversee facility registrations for various product types
Stay updated on regulatory requirements and provide strategic insights
Effectively communicate regulatory guidance to internal and external stakeholders

Non-Negotiable Qualifications

Bachelor's degree in Regulatory Affairs, Life Sciences, or related fields
5+ years of regulatory affairs experience in pharmaceutical, OTC, or consumer goods industries
Profound understanding of Canadian regulations for diverse product categories
Strong problem-solving skills and ability to thrive in a dynamic environment
Bilingualism to understand the documentation for Health Canada and to communicate with the teams in the US and Ontario

Additional Preferred Skills

Ability to work independently and collaboratively in a remote environment
Familiarity with virtual collaboration tools

Character Traits We Value

Problem-solving mindset
Strong decision-making abilities
Autonomy and accountability in work
Adaptability to ambiguity
A desire for impactful contributions and a strong voice within the organization

Please send your resume in Word format to Maia Slivinschi at maia.slivinschi@quantum.ca .

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OUR VIRTUAL DOORS ARE OPEN! We’re also bringing the interviews to you by various web applications, virtually! Contact us today for your next opportunity.

CNESST permit number: AP-2000158