Associate, Regulatory Affairs

1 month ago

Montréal QC, Canada Endo International Full time

Job Description Summary

At Paladin Pharma, we strive to offer a work environment that meets the diverse needs of our team members and advances the goals of the individual, the team and the company, while promoting flexibility, accountability and collaboration. If you're looking for a hybrid work environment, Paladin is the place for you

This position requires a presence at our office located in Montreal, two days a week, on Tuesdays and Wednesdays.

Reporting to the Manager, Regulatory Affairs, the main responsibility of the Associate, Regulatory Affairs is to ensure the timely approval and regulatory maintenance of products portfolio, which includes pharmaceutical, natural health products and medical devices. The Associate participates in various regulatory projects within the organization and with the company’s corporate partners.

Job Description
- Maintain regulatory compliance for approved products throughout their life cycle.
- Evaluate scientific data supporting post-approval changes (including CMC changes) against the Canadian regulations and all relevant guidelines and policies.
- Prepare regulatory submissions related to product monograph and/or labeling updates as well as chemistry/manufacturing changes as per Canadian requirements.
- Prepare quality regulatory submissions (LIII notification, SNDS, etc.) while ensuring accuracy, consistency, completeness, and compliance with regulatory standards according to predefined timelines.
- Support the preparation of NDSs.
- Ensure that the various databases, archiving and post-approval activities related to regulatory submissions are up-to-date according to departmental procedures.
- Review product labels to ensure compliance with Canadian regulations.
- Liaise with partners to collect documents and information (e.g., for submission preparation).
- Compile regulatory files in eCTD format, publish and submit eCTD submissions to Health Authorities.

Your Profile
- B.Sc. in life science or other relevant field, DESS in drug development or advanced degree is an asset
- 1+ years’ experience in the Canadian pharmaceutical regulatory field
- Good knowledge of the Canadian regulations as well as ability to interpret policies and guidelines
- Basic knowledge of drug development process and pharmaceutical business is an asset
- Good scientific knowledge
- Good knowledge of Microsoft Office (Word, Excel, etc.)
- Autonomy
- Strong orientation for thoroughness and attention to detail
- Ability to plan, prioritize and manage multiple simultaneous tasks and complete them within agreed timelines
- Bilingual (French and English) with excellent oral and written communication skills
- Paladin Pharma strives to offer a French-speaking work environment to all its Quebec-based employees. Although, as part of its francization program, Paladin Pharma has taken all reasonable measures to avoid imposing the requirement of English, knowledge, and proficiency in English for Associate, Regulatory Affairs_'_ position is at an advanced level, particularly due to the need to communicate and collaborate regularly in English with Regulatory authorities outside the province of Quebec._

What We Offer
- Hybrid work schedule
- Benefits package on first day
- Retirement Savings Plan (RRSP)
- Employer contribution to employee RRSP (DPSP)
- Employee Assistance Program (EAP)
- Telemedicine program
- Employee Referral Program ($)
- Free gym on site
- Free parking

Commitment to Diversity, Equity, and Inclusion:
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.

About Us:
Headquartered in Montreal, Canada, Paladin Pharma is a leading specialty pharmaceutical company focused on acquiring or in-licensing new pharmaceutical products for the Canadian market. Its dedicated employees have made Paladin one of Canada's pioneering specialty pharmaceutical companies.

Paladin is an operating company of Endo USA, Inc, a highly specialized pharmaceutical company that brings quality branded and generic products to patients through excellence in development, manufacturing, and marketing.

To learn more about us, visit our website at

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