Inventia Healthcare Pvt Ltd Vacancy | Regulatory Affairs Jobs

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About Inventia Healthcare Pvt Ltd Ambernath

Inventia, established in 1985, is a privately held pharmaceutical development and manufacturing company based in Mumbai, India. Inventia is dedicated to developing complex generic and novel innovative pharmaceutical products, which have been instrumental in enhancing the product portfolio of our partners along with improvement in the patient’s compliance and comfort.

We partner with clients across the globe, which range from mid-size companies to large local players and multinational companies. By working closely with our clients, we offer an end-to-end solution – right from research and development all the way to commercialization to support their expansion across emerging and regulated markets. Our state-of-the-art Pharmaceutical and Technology centre is complemented by a world-class production facility located at MIDC Ambernath.

It is fully compliant with all international regulatory requirements. With an ever-growing portfolio of niche products, Inventia’s presence has progressively increased to over 50 countries globally. By working closely with our clients, we believe in building and nurturing a long-term trusted relationship – with an aim to be their preferred development and manufacturing partner for any market.

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Inventia Healthcare Pvt Ltd Vacancy Details:

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Inventia Healthcare Limited – Thane
Opening in Regulatory Affairs
Designation: Asst Manager/Deputy Manager
Experience: 4-6yrs
Market: South East Asia and Latam

Job Summary
Regulatory requirements for preparation of Dossiers, Query response within timeline, renewal, and variation filing.
Preparation, compilation, and review of CMC documents within defined time schedules and in accordance with established Standards/Specifications/SOP and Protocols for submission to respective countries.
Review of technical documents like Specifications, Certificate Analysis, Test Methods, Testing Reports, Validation Reports, Batch Records, Stability Protocols, Stability Data, Product Development Reports and BA/BE Study Data Reports
Drafting and finalization of Quality Overall Summary.
Coordinate with other departments like R&D, Site QA, project and BD on requirements and technical issues.
Well aware of ICH guidance.

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