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Posted 25 days ago

Manager

@ Rubicon Research Limited

Canada

10+ years experience
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Overview

Rubicon Research Limited is hiring a Manager in Regulatory Affairs in Ontario, reporting to the AGM/GM for Key Markets. The role compiles dossiers and manages product registration filings in Canada, UK/EU and Australia, with support for US filings, and leads communications with Health Canada. The posting asks for 10-12 years of experience.

Responsibilities:

  • Compile dossiers for filings in Canada, UK/EU and AU
  • Respond to queries from regulatory agencies
  • Manage product registration filings in key markets
  • Manage communications and meetings with Health Canada
  • Support US filings as needed

Requirements summary:

  • B.S. or M.S. in Pharmaceutical Sciences
  • Proficiency in regulatory affairs
  • Knowledge of pharmaceutical product development
  • Excellent communication, planning and analytical skills
  • Prior experience with Health Canada preferred

Tools & skills

Source and dates

Employer career site / ATS feed · phenom

Employer posting date
2026-10-12
First seen by our source
2026-10-14
Source record updated
2026-10-14

These dates describe the source record, not a live verification that the employer is still hiring. Check the original posting.

Job details

SeniorityManager
DepartmentPhysicians & advanced practice
Experience10+ years
Work settingOffice
PositionMostly sitting
Physical demandsphysical low · computer high
LanguagesEnglish
EducationMaster’s degree (preferred), Bachelor’s degree (required)
Fields of studyPharmaceutical Sciences

Summary and details written by AI from the posting; the employer’s posting is the authority.

Rubicon Research Limited

Saved company profile

Historical company information from a saved The Jobs API profile (LinkedIn/Crunchbase fields). It is not live-verified; figures may have changed. Missing values remain unknown.

Full company description

Rubicon Research Limited is an IP-led, pharmaceutical company focused on developing value added products for the pharmaceutical industry as well as developing a portfolio of generic prescription and OTC products across a range of therapeutic categories. We leverage our proprietary technologies and specialized formulation development skills to provide solutions to complex delivery challenges. Our portfolio spans multiple dosage forms, including oral solids, oral liquids, ophthalmic, nasal, injectable, topical, drug device combinations and fixed-dose combinations. We have 50+ patents in drug delivery technologies, with over 28 approved products in the US. We also have 70+ products in development and 10+ products under review with the US FDA. Our state-of-the-art R&D center in Thane, Maharashtra, is built to GMP standards and equips us to carry out complete: • Oral solid dosage form development from pre-formulation studies up to pilot scale in a single facility • Oral liquid dosage form development suite up to pilot scale • Topical dosage form development suite up to pilot scale • Sterile dosage form development including injectable and ophthalmic dosages • Dedicated containment suite for development of highly potent products including hormonal products and oncology products In 2019, we acquired Impopharma Canada Ltd, establishing Rubicon Research Canada Ltd. This facility supports the development of pulmonary and nasal drug delivery systems and ophthalmic, otic, and dermal products. In 2020, we launched Rubicon Consumer Healthcare, a subsidiary that develops healthcare and personal wellness solutions for the Indian market. In 2020 we also launched Rubicon Academy, a learning platform for pharmaceutical professionals and students. Rubicon Research operates out of 4 locations—the corporate HQ and R&D center in Thane, India, the R&D center in Concord, Canada, the manufacturing site in Ambernath, India, and business development and regulatory office in Plainsboro, US.

LinkedIn followers
86,576
People associated on LinkedIn
1,241
Reported office locations
  • MedOne House, Plot. No B-75, Road No. 33, Wagale Industrial Estate, Thane , Maharashtra 400604, IN
  • Plot no. K-30/4 & 30/5; Additional M.I.D.C. Ambernath, Ambarnath, Thane, Maharashtra 421506, IN
  • Suite 605, Princeton Office Center II, 666 Plainsboro Road, Plainsboro, New Jersey 08536, US
  • 255 Spinnaker Way, Vaughan, Ontario L4K 4J1, CA
  • 50 Millstone Rd, Building 200, Suite 180, East Windsor, New Jersey 08520, US
Other recorded names
  • Rubicon Research Limited
Specialties
  • Formulation Development
  • ANDAs
  • 505(b2)
  • OTC Development
  • Analytical Method Development
  • Life Cycle Management Options
  • USFDA Approved GMP Site
  • Drug Delivery Technologies
  • and Clinical Trial Supplies
Profile identifies a recruitment agency
No

Rubicon Research Limited is an IP-led, pharmaceutical company focused on developing value added products for the pharmaceutical industry as well as developing a portfolio of generic prescription and OTC products across a range of therapeutic categories. We leverage our proprietary technologies and specialized formulation development skills to provide solutions to complex delivery challenges. Our portfolio spans…

FieldValue
IndustryPharmaceutical Manufacturing
Company size1,001-5,000 employees
HeadquartersThane , Maharashtra
Organization typePrivately Held
Year founded1999
SpecialtiesFormulation DevelopmentANDAs505(b2)OTC DevelopmentAnalytical Method DevelopmentLife Cycle Management OptionsUSFDA Approved GMP SiteDrug Delivery Technologiesand Clinical Trial Supplies
Open jobs on Jobsy1
LinkedInView page
Job description
Purpose

This position willbe responsible for regulatory product registration filings in key markets including Canada, UK/EU and AU and willneed to supportUS filings as required. The role will involve compilation of dossiers for filing in key markets, responding to queries from the regulatory agencies, and interacting withstakeholders. This position will also be

responsible for managing regulatory communications with HealthCanada.

Position / JobTitleManager
DepartmentRegulatory Affairs
Reporting To

AGM/GM – Regulatory Affairs (Key Markets)

LocationOntario
Years of Experience

10-12 years

Job Responsibilities

/ Deliverables

  • Compilation of dossiers for filings in key markets including Canada, UK/EU and AU for generic and new products.
  • Responding to queriesfrom regulatory agencies.
  • Co-ordinate with stakeholders and cross-functional team for filing documents and data.
  • Manage product registration filings in key markets.
  • Manage communications withHealth Canada.
  • Manage meetings anddiscussions with HealthCanada.
  • Support as needed, US filings in the pre-approval or post approval space.
  • Coordinate with globalregulatory teams.
  • Ensure business growthand operational excellence within regulatory setup.
Qualifications &Pre- Requisites
  • B.S/M.S in Pharmaceutical Sciences
  • Proficiency in Regulatory Affairs.
  • Knowledge about Pharmaceutical Product Development.
  • Excellent communication, planning, analytical and interpersonal skills.
  • Prior work experience with Health Canadais preferred.

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