Senior manager regulatory affairs

3 weeks ago

Thane, India Rubicon Research Limited Full time

About Rubicon Research Rubicon Research Limited is a fast-growing pharmaceutical formulations company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets. Our product portfolio comprises over 250 SKUs across more than 70 product families. We have an established marketing, sales, and distribution platform in the US through our subsidiaries Adva Gen Pharma that markets non-branded prescription products and Validus Pharmaceuticals that markets branded prescription products and promotes them to healthcare practitioners in the US. We have two US FDA inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with a range of drug development and manufacturing capabilities across dosage forms. Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA. For additional information visit Position Title: Senior Manager, Regulatory Affairs Type: Full time Location: Thane, Maharashtra. Position Overview: Manage product registrations in key regulated markets of Canada and Australia including preparing dossiers, submitting applications for product registrations, addressing query responses to obtain product approvals, submitting necessary post approval variations and meeting any annual requirements. Liaise with the cross-functional teams and manufacturing plant to obtain needful documents for product filings. Interacting with the regulatory bodies as required on administrative and technical matters. Manage a team of professionals to deliver the planned filings and necessary approvals. Key Responsibilities: Managing product registrations in key regulated markets of Canada and Australia including preparing dossiers, submitting applications for product registrations, and addressing query responses to obtain product approvals. Submitting necessary post approval variations and meeting any annual requirements in these markets. Liaise with the cross-functional teams and manufacturing plant to obtain needful documents for product filings. Interact with the regulatory bodies as required on administrative and technical matters. Manage a team of professionals to deliver the planned filings and necessary approvals. Qualification: Must have 10-15 years of Regulatory experience especially CA and AU markets. Should have experience in dossier preparation, submission, query responses and registration in key regulated countries. Should be an M. Pharm/M. Sc Good communication and planning skills Additional: Role is expected to work in all shifts. Expected to visit Ambernath or Satara site as required.

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