Job Description

Title: Senior Manager, Regulatory Affairs (18-month Contract)

Company: Ipsen Biopharmaceuticals Canada Inc.

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Summary / purpose of the position

This is an ideal role for a Manager of Regulatory Affairs that is looking to move into a Sr Manager of Regulatory Affairs role. You will report directly to the Head of the Regulatory Department and have responsibility for all products in the Ipsen portfolio and management of all regulatory submissions and activities.

The Senior Manager, Regulatory Affairs is responsible for leading the development and implementation of Canadian regulatory strategy, maintaining regulatory compliance and for lifecycle management of Ipsen's pipeline and marketed products in Canada. The primary objective is to oversee the planning and preparation of regulatory filings and ensure timely submission to Health Canada with optimal labelling and approval obtained within designated timelines. This role is also responsible for identifying and evaluating potential regulatory risks, providing guidance to the internal cross-functional team to ensure regulatory strategies align with corporate objectives, and building relationships with Health Canada and other relevant external parties. This role will also provide technical assistance, leadership, and support for special projects and teams as assigned.

This posting is for an 18-month contract opportunity.

Main responsibilities / job expectations

Manages the development and implementation of regulatory strategies for all marketed and developmental products.

Cross-functional responsibilities include working with various internal departments, including marketing and sales, to identify business opportunities based on changes in the regulatory environment.

Leads and chairs Health Canada meetings, leading preparation of meeting-related materials and meeting logistics.

Reviews all promotional and non-promotional materials and provides risk assessments and advice for new concepts.

Leads the planning and preparation of regulatory submissions (NDSs, SNDSs, CTAs, NCs).

Manages submission and project workload of Submission Associates for Regulatory Affairs.

Provides regulatory risk assessments, mitigation options and advice to other functional areas.

Prepares Product Monograph updates for labelling compliance with Company Core Data Sheets.

Establishes and maintains close communications and good working relationships with Health Canada, internal cross-functional partners and Global colleagues.

Primary Regulatory contact with Health Canada and Global Ipsen divisions.

Other Regulatory Affairs duties, as required, to ensure ongoing compliance with Canadian requirements and the achievement of applicable goals and objectives.

Supports inspection preparation with internal departments and contractors (in collaboration with Global Quality Audit as needed).

Supports maintenance of SOPs across Regulatory related functional area.

Knowledge, abilities & experience

Education / Certifications:

B.Sc in Life Science or relevant scientific field (e.g., pharmacology, toxicology, chemistry).

Approximately 7+ years in pharmaceutical Regulatory Affairs/Compliance/Quality Assurance.

Excellent organizational and project management skills.

Proficiency in use of various software packages such as Outlook, Word, WordPerfect, Excel, PowerPoint, Access and Adobe Acrobat is required.

Strong background in regulatory compliance management.

Experience in writing and implementing compliance policies, procedures and quality systems is essential.

Management training and proven ability to lead others to work together.

Strong leadership skills and ability to work successfully in a cross-functional environment.

Excellent written, verbal and presentation skills.

Ability to balance short and long-term goals.

Key Technical Competencies Required

Understanding of Canadian Regulatory requirements, including interpretation of the Food & Drugs Act and Regulations, relevant policies and guidelines.

Scans the scientific, regulatory and business environments for current best practices, guidelines and approaches.

Anticipates future learning requirements, develops capabilities and staff performance in line with business needs.

COVID-19 Vaccination Policy

Ipsen Biopharmaceuticals Canada Inc. is committed to protecting the health and well-being of our employees, their families, and the patients we serve. As such, Ipsen has implemented a mandatory COVID-19 vaccination policy for all employees and contractors. All offers of employment will be conditional upon either (i) proof of full COVID-19 vaccination or (ii) proof of need for accommodation under relevant human rights legislation, and Ipsen's determination that the requested accommodation can be provided without posing a direct threat to others in the workplace or creating an undue hardship for the Company. You will be required to submit proof of full vaccination or proof of need for accommodation during our background screening process.

Accessibility

Ipsen Biopharmaceuticals Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.

Thank you for considering Ipsen as an employer of choice. We wish you all the best with your application.