Top Benefits
About the role
Job Description:
Purpose- This position will be responsible for regulatory product registration filings in key markets including Canada, UK/EU and AU and will need to support US filings as required. The role will involve compilation of dossiers for filing in key markets, responding to queries from the regulatory agencies, and interacting with stakeholders. This position will also be responsible for managing regulatory communications with Health Canada.
Position / Job Title-Manager Department-Regulatory Affairs Reporting To-AGM/GM-Regulatory Affairs (Key Markets) Years of Experience-10-12 years Job Type-Full-time Location-Ontario
Job Responsibilities / Deliverables- Compilation of dossiers for filings in key markets including Canada, UK/EU and AU for generic and new products. Responding to queries from regulatory agencies. Co-ordinate with stakeholders and cross-functional team for filing documents and data. Manage product registration filings in key markets. Manage communications with Health Canada. Manage meetings and discussions with Health Canada. Support as needed, US filings in the pre-approval or post approval space. Coordinate with global regulatory teams. Ensure business growth and operational excellence within regulatory set up. 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 Canada is preferred Benefits- Dental care Extended health care Life insurance On-site parking Application question(s)- Experience in regulatory product registration filings Experience in compilation of dossiers for filings in key markets including Canada, UK/EU and AU for generic and new products. Work Location-Remote
About Rubicon Research Limited
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.
Similar Jobs
Top Benefits
About the role
Job Description:
Purpose- This position will be responsible for regulatory product registration filings in key markets including Canada, UK/EU and AU and will need to support US filings as required. The role will involve compilation of dossiers for filing in key markets, responding to queries from the regulatory agencies, and interacting with stakeholders. This position will also be responsible for managing regulatory communications with Health Canada.
Position / Job Title-Manager Department-Regulatory Affairs Reporting To-AGM/GM-Regulatory Affairs (Key Markets) Years of Experience-10-12 years Job Type-Full-time Location-Ontario
Job Responsibilities / Deliverables- Compilation of dossiers for filings in key markets including Canada, UK/EU and AU for generic and new products. Responding to queries from regulatory agencies. Co-ordinate with stakeholders and cross-functional team for filing documents and data. Manage product registration filings in key markets. Manage communications with Health Canada. Manage meetings and discussions with Health Canada. Support as needed, US filings in the pre-approval or post approval space. Coordinate with global regulatory teams. Ensure business growth and operational excellence within regulatory set up. 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 Canada is preferred Benefits- Dental care Extended health care Life insurance On-site parking Application question(s)- Experience in regulatory product registration filings Experience in compilation of dossiers for filings in key markets including Canada, UK/EU and AU for generic and new products. Work Location-Remote
About Rubicon Research Limited
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.