Pooja Chavan

Regulatory Affairs Associate at Rubicon Research Pvt Ltd, Thane | Lupin Pune- Quality Assurance

Role: Regulatory Affairs Associate at Rubicon Research Limited
Location: Mumbai, IN
LinkedIn followers: 500 followers

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About Pooja Chavan

Regulatory Affairs • Prepared and submitted regulatory dossiers (ANDA, NDA) for…

Experience

Regulatory Affairs Associate
Rubicon Research Limited
Jun 2024 — Present · Thane, IN
Review Dossier preparation and submission for ANDA and NDA.• Collaborated with QA and R&D teams to ensure compliance with regulatory requirements.• Prepared and submitted Periodic Adverse Drug Experience Report (PADER).• Maintained up-to-date knowledge of FDA regulations and guidelines to facilitate timely approvals.• Prepared necessary documentation for annual report submissions, ensuring accuracy and timeliness of information provided to regulators.• Prepared and submitted regulatory file applications and supporting documentation

Contact information

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•••••@rubicon.co.in
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Current company

Rubicon Research Limited

Pharmaceutical Manufacturing · 1.2K employees · Founded 1999 · Thane, Maharashtra, India

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.

rubicon.co.in

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