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  • Assistant General Manager Regulatory Affairs - thane - Rubicon Research Limited

    Rubicon Research Limited
    Rubicon Research Limited thane

    2 weeks ago

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    Description

    About Us

    Rubicon Research Limited is a fast-growing pharmaceutical formulation 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 AdvaGen Pharma which markets non-branded prescription products, and Validus Pharmaceuticals which 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 various drug development and manufacturing capabilities across dosage forms.

    Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA.

    Job Title: Assistant General Manager, Regulatory Affairs

    Type: Full-time

    Location: Thane, Maharashtra.

    Job Overview:

    This position will lead the Post Approval Regulatory Team and will be responsible for all post-approval deliverables.

    Key Responsibilities:


    • Review and submit all post-approval submissions and variations of approved products.


    • Coordinate within Development Centers, Manufacturing Units, Quality Units, Supply Chain, CMOs for Life Cycle Management of projects.


    • Identify regulatory concerns and recommend regulatory strategies for post-approval filings.


    • Monitor regular submission of Annual Reports and PADERS.


    • Lead the labeling and the publishing teams and ensure smooth working.


    • Support Organizational Initiatives and People management.


    • Ensure Business Growth and Operational Excellence within the Regulatory Setup.

    Required Skills and Experience:


    • Proficiency in Regulatory Affairs.


    • Knowledge about Pharmaceutical Manufacturing.


    • Excellent leadership, communication, planning, interpersonal skills and act as a solution provider.


    • Exposure to various regulatory bodies like the US FDA, MHRA, TGA, and HC.


    • Manage 100+ post-approval submissions annually.


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