Current jobs related to Senior Associate, Regulatory Affairs - Brampton, Ontario - sun pharma

  • Regulatory Affairs Specialist

    6 days ago

    Brampton, Ontario, Canada Medtronic Full time

    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 LifeReporting to the Manager Regulatory affairs, the Specialist, Regulatory Affairs will evaluate,...

  • Regulatory Affairs Specialist

    7 days ago

    Brampton, Ontario, Canada Medtronic Full time

    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 LifeReporting to the Manager Regulatory affairs, the Specialist, Regulatory Affairs will evaluate,...

  • Sr Regulatory Affairs Specialist

    1 week ago

    Brampton, Ontario, Canada Medtronic Full time

    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 LifeThis position has a focus on the regulatory process accountable for providing high quality...

  • Sr Regulatory Affairs Specialist

    1 week ago

    Brampton, Ontario, Canada Medtronic Full time

    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 LifeThis position has a focus on the regulatory process accountable for providing high quality...

  • Senior Manager, Public Affairs and Advisory

    1 week ago

    Brampton, Ontario, Canada Region of Peel Full time

    Job DescriptionSenior Manager, Public Affairs and AdvisoryCorporate Services - CommunicationsStatus:Regular Full TimeSalary Range:  $147 , $184,370.00 per annum plus comprehensive benefitsHiring Range: $147, $165, per annum plus comprehensive benefitsWork mode:Hybrid*  see below for more details about this work mode.Location:10 Peel Centre Drive,...

  • Associate Manager of Health

    1 week ago

    Brampton, Ontario, Canada Cogir Senior Living Canada Full time

    DescriptionCogir Senior Living manages retirement residences across the country. We offer a range of senior living options including independent living, assisted living and memory care.For over 25 years, we have dedicated every day to the happiness of retirees.Human Focus – Creativity - ExcellenceWe're seeking individuals with a purpose and passion for...

  • Scientific Affairs

    3 days 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...

  • senior specialist, plumbing

    2 weeks ago

    Brampton, Ontario, Canada City of Brampton Full time

    Job Description JOB TITLE: SENIOR SPECIALIST, PLUMBING DEPARTMENT: PLANNING, BUILDING & GROWTH MANAGEMENT POSTING NUMBER: 106870 NUMBER OF POSITIONS: 1 JOB STATUS & DURATION: Full Time Permanent HOURS OF WORK: 35 hour workweek LOCATION: FCCC McLaughlin Rd S. SALARY GRADE: 015 SALARY RANGE: 1ST STEP: $104,813.80 per annum 2ND STEP: $110,401.20...

  • Registered Nurse

    1 week ago

    Brampton, Ontario, Canada Sienna Senior Living Full time

    Registered NurseWoodhall Park Community - BramptonRate of Pay: $ $54.59 (as per collective agreement)This posting is for an existing vacancy.At Sienna you won't just fill a position; you will build lasting relationships with residents who call Woodhall Park their home. Join us in a role where knowing each resident not just by name, but by story, is not just...

  • Registered Nurse

    4 days ago

    Brampton, Ontario, Canada Sienna Senior Living Full time

    Registered NurseTullamore CommunityAt Sienna you won't just fill a position; you will build lasting relationships with residents who call Tullamore their home. Join us in a role where knowing each resident not just by name, but by story, is not just possible, it is expected. Our purpose is to cultivate happiness in daily life We truly believe it is a...

Senior Associate, Regulatory Affairs

2 weeks ago

Brampton, Ontario, Canada sun pharma Full time
Title: Senior Associate, Regulatory Affairs

Date: Dec 10, 2025

Location: Sun Pharma Canada Inc.

Company: Sun Pharma Canada Inc.

Job purpose

The 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 responsibilities

  • Plan, coordinate, compile and file drug product submissions for Canada and the U.S. for a variety of dosage forms (solid oral, liquids, topical semisolids and injectables) in eCTD format to Canada & US (e.g. DMFs, ANDS, NDS, ANDA, NDAs, S/NDSs, DINs, CTAs, NCs, INDs, provincial formulary submissions etc.) for the successful registration of drug product for domestic and international markets.
  • Support in preparation for regulatory filing to EU, UK & Australia.
  • 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.
  • Plan, coordinate, compile and file post approval submissions for FDA (CBE supplement, PAS) and Health Canada (Supplement).
  • Review Change Controls and determine filling requirements for all markets.
  • Liaise with Health Canada and Provincial regulators on all aspects of the drug submission, follow up for review status and project updates.
  • Review submissions prepared by associates and senior associates.
  • Work on more complex projects which involve identifying and resolving issues in a timely manner.
  • Review and approve various product labeling components and marketing materials.
  • In consultation with the manager, provide regulatory guidance and expertise to Sales & Marketing, R&D, QC/QA, and Operations departments of Sun Pharma organization.
  • Assist in preparation and compilation of FDA and Health Canada pre-approval and GMP inspections.
  • Maintain current awareness of regulatory guidelines (Health Canada, FDA, ICH, EMeA, UK-MHRA, 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
  • At least five (5) to seven (7) years of hands-on Regulatory Affairs experience of filing and managing Canadian and USA submissions, including electronic submissions in eCTD formats.
  • Expertise in chemistry and manufacturing, labeling and format requirements for drug product registration for FDA (ANDA, NDA, DMF, IND) and Health Canada (CTA, ANDS, S/ANDS, NDS, DIN, DMF).
  • Knowledge of the use of eCTD Software for preparing and filing submissions preferred.
  • Knowledge of GMP requirements and QA/QC procedures.
  • Excellent interpersonal, written and verbal communication skills.
  • Ability to plan, coordinate and work effectively in a team-oriented environment.
  • Ability to independently prepare written responses to deficiency letters from regulatory agencies, as well as obtain approval of changes to approved drug products.
  • Superior computer software skills (Microsoft Word, Excel, Access, PowerPoint, Adobe Acrobat, Document Management Systems, Artwork management system).
  • Strong organizational ability and management of multiple priorities combined with proven ability to meet strict and established timelines.
  • Multi-tasking various tasks and adhering to strict timelines.

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 role