Specialist, Regulatory Affairs - Mississauga - Ipsen

    Ipsen
    Ipsen Mississauga

    5 days ago

    Full time
    Description

    Specialist, Regulatory Affairs


    Join to apply for the Specialist, Regulatory Affairs role at Ipsen.

    Summary


    As a Specialist, Regulatory Affairs, you will support the Associate Director and Manager of Regulatory Affairs and oversee submission operations across all therapy areas. You will manage a portfolio of projects for approved Ipsen products and the lifecycle of the pipeline in Canada, ensuring timely and compliant regulatory filings to Health Canada. The role maintains strong relationships with Health Canada and internal/external stakeholders, and provides operational support for special projects.

    Main Responsibilities & Technical Competencies

    • Assist in the preparation and compilation of regulatory submissions (e.g., NDSs, SNDSs, CTAs, Level III, NCs).
    • Support the preparation and review of responses to Health Canada questions and queries in a timely manner.
    • Participate and assist in Health Canada meetings for assigned products, including preparation of meeting-related materials and logistics.
    • Prepare Product Monograph updates for labelling, comply with CCDS, and manage internal labelling updates through GLAMS.
    • Assist Associate Director and Manager in negotiations with Health Canada during the review cycle to secure prompt regulatory approval and optimal labelling.
    • Collaborate with local and global teams to facilitate regulatory activities.
    • Support the development and implementation of regulatory strategies for marketed and developmental products.
    • Identify and evaluate potential regulatory risks, providing guidance to cross‑functional teams to align strategies with corporate objectives.
    • Maintain SOPs across the regulatory functional area.
    • Establish and maintain close communications with Health Canada, cross‑functional partners, and global colleagues.
    • Perform other Regulatory Affairs duties as required.
    • Participate in global, cross‑functional, and departmental initiatives.
    • Adhere to all corporate policies and procedures.

    Knowledge & Experience (essential)

    • 1+ year of experience in pharmaceutical Regulatory Affairs.
    • Basic understanding of drug development and commercialization process.
    • Strong organizational, attention to detail, and project management skills.
    • Strong written, verbal, and presentation skills.
    • Ability to balance short‑ and long‑term goals.
    • Proactive, constantly seeking learning and development.
    • Collaborative, works well in a team.

    Education / Certifications (essential)

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

    Education / Certifications (preferred)

    • Regulatory Affairs Certificate.

    Language(s) (essential)

    • English.

    Language(s) (preferred)

    • French.

    Seniority level


    Not Applicable

    Employment type


    Full‑time

    Job function


    Legal

    Industries


    Pharmaceutical Manufacturing


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