Publié il y a 25 jours
Manager
@ Rubicon Research Limited
Canada
En bref
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.
Responsabilités :
- 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
Résumé des exigences :
- 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
Outils et compétences
Source et dates
Site carrière / système de candidatures · phenom
- Date publiée par l’employeur
- 2026-10-12
- Première détection par notre source
- 2026-10-14
- Mise à jour du dossier source
- 2026-10-14
Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.
Détails du poste
| Niveau | Gestionnaire |
| Domaine | Médecins et pratique avancée |
| Expérience | 10 an(s) et plus |
| Milieu de travail | Bureau |
| Position | Surtout assis |
| Exigences physiques | physique faible · ordinateur élevé |
| Langues | English |
| Formation | Maîtrise (préféré), Baccalauréat (exigé) |
| Domaines d’études | Pharmaceutical Sciences |
Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.
Rubicon Research Limited
Profil d’entreprise sauvegardé
Renseignements historiques provenant d’un profil The Jobs API sauvegardé (champs LinkedIn/Crunchbase). Ils ne sont pas vérifiés en temps réel; les chiffres peuvent avoir changé. Les valeurs manquantes restent inconnues.
Description complète de l’entreprise
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.
- Abonnés LinkedIn
- 86 576
- Personnes associées sur LinkedIn
- 1 241
- Bureaux déclarés
- 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
- Autres noms enregistrés
- Rubicon Research Limited
- Spécialités
- 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
- Le profil indique une agence de recrutement
- Non
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…
| Champ | Valeur |
|---|---|
| Secteur | Pharmaceutical Manufacturing |
| Taille | 1,001-5,000 employees |
| Siège social | Thane , Maharashtra |
| Type d’organisation | Privately Held |
| Fondée en | 1999 |
| Spécialités | Formulation DevelopmentANDAs505(b2)OTC DevelopmentAnalytical Method DevelopmentLife Cycle Management OptionsUSFDA Approved GMP SiteDrug Delivery Technologiesand Clinical Trial Supplies |
| Offres sur Jobsy | 1 |
| Voir la page |
| 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 / JobTitle | Manager |
| Department | Regulatory Affairs |
| Reporting To | AGM/GM – Regulatory Affairs (Key Markets) |
| Location | Ontario |
| Years of Experience | 10-12 years |
Job Responsibilities / Deliverables |
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| Qualifications &Pre- Requisites |
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