Specialist, Regulatory Affairs

About Ipsen:

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology Rare Disease and Neuroscience. Supported by nearly 100 years of development experience with global hubs in the U.S. France and the U.K we tackle areas of high unmet medical need through research and innovation.

Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration excellence and impact. At Ipsen every individual is empowered to be their true selves grow and thrive alongside the companys success. Join us on our journey towards sustainable growth creating real impact on patients and society!

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Summary

As a Specialist Regulatory Affairs you will be responsible for supporting the Associate Director Regulatory Affairs and Manager Regulatory Affairs as well as submission operations across all therapy areas within the Regulatory Affairs department. This role will have responsibility for a portfolio of projects consisting of activities for approved Ipsen products and the lifecycle management of Ipsens pipeline and marketed products in Canada. The primary objectives are to support the planning and preparation of regulatory filings and ensure timely submissions to Health Canada with optimal labelling and approval obtained within designated timelines. This role has a key part to play in maintaining strong relationships with Health Canada and other relevant internal and external parties. This role will also provide operational assistance and support for special projects and teams as assigned.

Main Responsibilities & Technical Competencies

• Assist in the preparation and compilation of regulatory submissions (i.e. NDSs SNDSs CTAs Level IIIs NCs etc.).

• 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 meeting logistics.

• Prepare Product Monograph updates for labelling in compliance with Company Core Data Sheets (CCDS) and manage internal Ipsen process for labelling updates through the designated packaging system (GLAMS).

• Assist Associate Director and Manager in negotiations with Health Canada throughout the submission review cycle to ensure prompt regulatory approval and optimal labelling.

• Work with local teams and Global colleagues to facilitate regulatory activities.

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

• Support the identification and evaluation of potential regulatory risks providing guidance to the internal cross-functional teams to ensure regulatory strategies align with corporate objectives.

• Support maintenance of SOPs across Regulatory related functional area.

• Establish and maintain close communications and good working relationships with Health Canada internal cross-functional partners and Global colleagues.

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

• Participate in global cross-functional and departmental initiatives.

• Adhere to all corporate policies and procedures.

Knowledge & Experience

Knowledge & Experience (essential):

• 1 years 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 and seeks to constantly learn and develop

• Collaborative with the ability to work well with others in a team

Education / Certifications (essential):

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

Education / Certifications (preferred):

• Regulatory Affairs Certificate

Language(s) (essential):

• English

Language(s) (preferred):

• French