Associate, Regulatory Affairs

7 months ago

Montréal, Canada Endo International Full time

Job Description Summary

At Paladin, 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 St-Laurent, 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 participate to the timely approval and regulatory maintenance of products. They evaluate scientific data supporting post-approval changes against the Canadian regulations and all relevant guidelines and policies. They also provide support and participate in the preparation of high-quality submissions for prescription, non-prescription, natural health products, biologics and medical devices. Finally, the Associate contributes to various regulatory projects.

**Job Description**:

- Prepare and submit files, such as annual notifications, in eCTD format.
- Prepare accurate record of changes and ensure appropriate data/documentation is archived.
- Participate in the evaluation of scientific data (CMC) and preparation of submissions (including product monograph or labeling update) according to Canadian regulation and all relevant guidelines and policies.
- Assemble, compile regulatory files in eCTD format, when applicable, includes uploading and publishing documents in eCTD software (e.g. convert to PDF, bookmark, hyperlink).
- Review product labels to ensure compliance with Canadian regulations.
- Ensure that the various internal RA databases, archiving and post-approval activities related to regulatory submissions are maintained according to the departmental procedures.
- Communicate with external partners to obtain documentation (including GMP evidence, clinical data, etc.) necessary for RA dossiers.

Your Profile
- Bachelor’s degree in life science or equivalent.
- DESS in drug development is a strong asset.
- Minimum of 1-2 years in the Canadian regulatory field within the pharmaceutical industry.
- Good knowledge of the Canadian regulations & guidelines.
- Knowledge of drug development process and pharmaceutical business represent an asset.
- Thoroughness & attention to detail.
- Bilingual (French and English) with excellent written communication skills:

- Paladin Labs strives to offer a French-speaking work environment to all its Quebec-based employees. Although, as part of its francization program, Paladin Labs has taken all reasonable measures to avoid imposing the requirement of English, knowledge and proficiency in English for the Associate Regulatory Affairs position is at an intermediate level, particularly due to the need to communicate and write regularly in English with regulatory authorities outside the province of Quebec._

What We Offer
- Hybrid work schedule
- Entitled to 10 statutory holidays
- Benefits package on first day
- Retirement Savings Plan (RRSP)
- Employer contribution to employee RRSP (DPSP)
- Training and Development Programs
- 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 Labs 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 International plc (NASDAQ: ENDP), 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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