ABOUT NATCO:

Natco Pharma (Canada) Inc. is the Canadian subsidiary of Natco Pharma Limited, a vertically integrated pharmaceutical company focused on R&D and the manufacturing of pharmaceutical drug products. We are a trusted supplier of medicines evidenced from our work with the world’s largest drug companies. Natco is renowned for trust, reliability, and commitment to our customers.
Natco Pharma (Canada) Inc. is headquartered in Mississauga and is supported by a strong cross-functional team.
We are currently looking for an experienced candidate to assume the role of Senior Associate, Regulatory Affairs. This position will report to Regulatory Affairs Manager and work with an experienced team managing Natco Pharma (Canada) Inc’s product portfolio. This role will be hybrid mode and based at our Mississauga office.

IF YOU ARE INTERESTED IN JOINING OUR TEAM, AND MEET THE REQUIREMENTS FOR THE POSITION, PLEASE SUBMIT YOUR RESUME TO: CAREERS@NATCOPHARMA.CA USING “SENIOR ASSOCIATE, RA” IN THE SUBJECT LINE.

We thank all applicants for their interest in Natco Pharma (Canada) Inc., but only candidates selected for interviews will be contacted. Applications from recruiters or employment agencies will not be considered without a signed services agreement.
Job Types: Full-time, Permanent
Pay: $70,000.00-$85,000.00 per year

Benefits:

• Company events
• Dental care
• Extended health care
• Life insurance
• On-site parking
• Vision care

Schedule:

• Monday to Friday

Application question(s):

• Do you have a minimum of 5 years’ experience filing generic drug submissions to Health Canada?
• Do you have a minimum of 5 years’ CMC submission experience?
• Do you have an RAC certification or post-graduate certificate in Regulatory Affairs?
• How many years of experience do you have with Canadian labelling submissions?
• How many years of experience do you have with eCTD publishing software?

Work Location: Hybrid remote in Mississauga, ON L5N 1P

• Prepare and /or review high quality pharmaceutical pre-approval (NDS, ANDS) and product lifecycle (SNDS, SANDS, Level III) submissions to Health Canada.
• Coordinate with internal and external stakeholders for drug submission documentation.
• Publish high quality submissions in eCTD using publishing softwares and tools that meet the HC’s validation criteria and internal quality standards.
• Prepare, review, and manage artworks, product monographs and other labelling material in accordance with Health Canada’s labelling requirements.
• Liaise with Health Canada and prepare written responses to deficiency letters from Health Canada in the stated time frame.
• Assess change controls according to quality change management system.
• Help identify changes in regulatory legislation and assess its impact on product(s) or projects.
• Maintain and contribute to improving departmental procedures/processes to ensure compliance with the current regulations and other applicable industry standards.
• Support the Regulatory Affairs Canada team as required.