Associate, Regulatory Affairs

3 days ago

Brampton, Ontario, Canada SUN PHARMA Full time

Job Purpose
Prepare and file drug product submissions to the US FDA, Health Canada as well as to assist with global drug product registrations.

Duties And Responsibilities

  • Prepare and / or review submissions to Health Canada and FDA for a variety of dosage forms (solid oral, liquids, topical semisolids and injectables) in eCTD format (e.g. DMFs, ANDS, NDS, ANDA, NDAs, S/NDSs, DINs, CTAs, NCs, INDs, provincial formulary submissions etc.) for the successful registration of drug products for domestic and international markets.
  • Prepare submissions in eCTD format which involves full understanding of the use of Adobe Acrobat to create bookmarks and links.
  • Prepare written responses to deficiency letters from regulatory agencies in the stated time frame.
  • Prepare and file post approval submissions for FDA (CBE supplement, PAS) and TPD (Notifiable Change, Supplement).
  • Maintain approved product monographs to comply with CRP-PMs.
  • Maintain approved drug products for FDA (Annual Report) and TPD (Annual Drug Notification).
  • Review and approve various product labeling components and marketing materials.
  • Review internal documentation (master batch records, specifications, labeling, product monographs) for adherence to regulatory guidelines.
  • Assist in global drug product registrations.
  • Maintain current awareness of regulatory guidelines (Health Canada, FDA, ICH, European Medicines Agency - EMeA, MHRA, Therapeutic Goods Administration –TGA Australia, etc.).
  • Other duties as required by the Manager.

Additional Responsibility (Only Applicable To Customer Facing Roles)
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

  • Minimum B. Sc. in a Chemistry, Pharmacy or Life Science discipline combined with at least three (3) to five (5) years of relevant experience within a Canadian and / or USA Regulatory Affairs pharmaceutical environment.
  • Strong working knowledge of current regulatory guidelines for FDA and / or TPD.
  • Experience with eCTD submissions and knowledge of GMP and QA/QC procedures is preferred.
  • Knowledge of the use of eCTD Software for preparing and filing submissions preferred.
  • Strong organizational ability to maintain a complex and high volume of technical information up to date.
  • Proficiency with applicable computer software – Microsoft Office including Word, Excel and PowerPoint and Adobe Acrobat and Document Management Systems.
  • Excellent interpersonal, written and verbal communication skills.
  • Ability to plan, coordinate and work effectively in a team-oriented environment.

Working conditions

  • Multidisciplinary office, R&D and manufacturing environment
  • Extensive use of computer
  • Varied work schedule to meet deadlines, as required

Physical Requirements
Office based

  • Senior Associate, Regulatory Affairs

    5 days ago

    Brampton, Ontario, Canada sun pharma Full time

    Title: Senior Associate, Regulatory AffairsDate: Dec 10, 2025Location: Sun Pharma Canada Inc.Company: Sun Pharma Canada Inc.Job purposeThe goal of the Senior Regulatory Affairs Associate is to plan, coordinate, compile, submit, obtain approval, and maintain drug product registrations for the US, Canada, EU, UK & Australia as well as assist global drug...

  • Senior Associate, Regulatory Affairs

    3 days ago

    Brampton, Ontario, Canada SUN PHARMA Full time

    Job PurposeThe goal of the Senior Regulatory Affairs Associate is to plan, coordinate, compile, submit, obtain approval, and maintain drug product registrations for the US, Canada, EU, UK & Australia as well as assist global drug product registrations.Duties And ResponsibilitiesPlan, coordinate, compile and file drug product submissions for Canada and the...

  • Director, Regulatory Affairs

    5 days ago

    Brampton, Ontario, Canada sun pharma Full time

    Title: Director, Regulatory Affairs (Contract)Date: Jan 22, 2026Location: Sun Pharma Canada Inc.Company: Sun Pharma Canada Inc.Sun Pharmaceuticals Industries Inc. is the fifth largest generic pharmaceutical company in the world, and is rapidly building a branded product presence globally and specifically in Canada. Sun Pharma Canada Inc. has a team of 70...

  • Director, Regulatory Affairs

    3 days ago

    Brampton, Ontario, Canada SUN PHARMA Full time

    Sun Pharmaceuticals Industries Inc. is the fifth largest generic pharmaceutical company in the world, and is rapidly building a branded product presence globally and specifically in Canada. Sun Pharma Canada Inc. has a team of 70 plus employees and a portfolio of 5 commercial products in the branded business and a pipeline of molecules in development. Our...

  • Sr Regulatory Affairs Spec

    3 days ago

    Brampton, Ontario, Canada Medtronic Full time $88,000 - $110,000

    At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeThe Senior Regulatory Affairs Specialist is responsible for developing regulatory strategies,...

  • Scientific Affairs

    2 weeks ago

    Brampton, Ontario, Canada Loblaw Full time

    Come make your difference in communities across Canada, where authenticity, trust and making connections is valued – as we shape the future of Canadian retail, together. Our unique position as one of the country's largest employers, coupled with our commitment to positively impact the lives of all Canadians, provides our colleagues a range of opportunities...

  • Personal Banking Associate

    1 week ago

    Brampton, Ontario, Canada BMO Full time $36,000 - $54,500

    Application Deadline:01/14/2026Address:20 Brisdale Drive Job Family Group:Retail Banking Sales & ServiceDelivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and through...

  • Personal Banking Associate

    1 week ago

    Brampton, Ontario, Canada Bank of Montreal Full time $36,000 - $54,500

    Application Deadline:12/19/2025Address:9505 Mississauga Road Job Family Group:Retail Banking Sales & ServiceDelivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and through...

  • Personal Banking Associate

    5 days ago

    Brampton, Ontario, Canada BMO Full time $36,000 - $54,500

    Application Deadline:12/28/2025Address:8950 Hwy Job Family Group:Retail Banking Sales & ServiceDelivers exceptional service to BMO customers and prospects. Identifies customer needs and provides advice and guidance regarding financial solutions that are in the best interests of customers. Works collaboratively within the branch and through various channels...

  • Snr Eng Netwk Arch Standards

    5 days ago

    Brampton, Ontario, Canada Rogers Communications Full time

    Our Technology team wakes up every day with one goal in mind - connecting Canadians to the people and things that matter most. Together, we are proud to support 30 million Canadians each month through managing a robust portfolio that champions leading-edge technology. We drive large-scale, complex, and high-visibility technology projects and programs that...