Regulatory affairs associate Jobs in Kitchener, ON

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

For more information visit : www.apotex.com .

Job Summary

The Associate Director, Regulatory Affairs is responsible for managing and supporting the registration and post-approval maintenance of Searchlight products in various jurisdictions. The position manages junior RA internal staff as well as third party providers / contractors and works closely with the company’s business partners to achieve company objectives.

Job Responsibilities

• Manage and support the submission process for new drug submissions and post-approval changes in various jurisdictions in support of business objectives.
• Develop responses to regulatory agency requests (Health Canada, EU, FDA), and / or review responses and documents intended for submission to agencies to ensure compliance with regulatory standards.
• Plan and conduct pre-submission meetings with Health Canada.
• Provide CMC expertise and author sections of regulatory drug submissions for new products and post-approval changes.
• Actively manage and collaborate with external service providers.
• Coordinate the completion of and review agreements with partners and service providers.
• Create, maintain and identify the need for regulatory processes to ensure compliance with applicable regulatory requirements.
• Review and approve product labelling. Coordinate revisions to labelling (where necessary).
• Review Canadian promotional and advertising materials to ensure compliance with Health Canada and the Pharmaceutical Advertising Advisory Board (PAAB) Code of Advertising Acceptance.
• Maintain awareness of the international regulatory environment and assess impact of pertinent changes that may affect the organization.
• Provide regulatory expertise in support of the Searchlight product portfolio and business development opportunities.
• Contribute to strategic planning for regulatory projects.
• Prepare scientific briefing packages and identify possible issues / risks in product registrations and develop strategies for resolution.
• Conduct diligence reviews and generate reports to support company objectives in acquiring new products.
• Responsible for assessing new regulatory or updated regulatory requirements and identifying impact to the organization.
• Responsible for identifying and supporting process improvements in regulatory practices.
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values – Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.
• All other duties as assigned.

Job Requirements

Education

Knowledge, Skills and Abilities

Experience

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Science

Industries

Pharmaceutical Manufacturing

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