Regulatory Affairs - Vadodara

BDR Pharmaceuticals

4 - 9 years

4 - 9 Lacs

vadodara

Posted:3 hours ago| Platform:

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Skills Required

ctd/ectd cmc anda/maa submissions regulatory compliance regulatory submissions dossier preparation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities:

Independently compile and review submission dossiers in CTD/eCTD format for regulatory authorities like US FDA, EMA, and ANVISA.
Review CMC documentation for regulatory compliance, strategize filing categories, and ensure submissions are completed within deadlines.
Conduct due diligence for new product registrations and provide CMC strategy for complex injectable products.
Work closely with internal and external stakeholders to ensure timely and accurate submissions.
Evaluate change controls and their impact on regulatory submissions, developing appropriate regulatory strategies.
Stay updated with regulatory guidelines and changes to ensure compliance with submission standards.

Requirements:

M.Pharm/PhD/MSc in Chemistry, Biotechnology, or related fields.
4-10 years of experience in CMC and regulatory submissions for the US, EU, and Brazil markets.
In-depth knowledge of ANDA, MAA submissions.
Experience with eCTD software and a solid understanding of regulatory requirements.
Strong communication skills and the ability to work in a collaborative environment.

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