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Immacule Life Sciences
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Regulatory Affairs US Market

Regulatory Affairs US Market

Immacule Life Sciences

8 - 10 years

|

8 - 13 Lacs

Posted:13 hours ago| Platform:

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Skills Required

Submission Anda Dossier CMC USFDA Regulatory Affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities

Prepare ANDA dossiers, CMC modules, and submission documents for US FDA approval.

Post approval and life cycle management of approved ANDA & suppliment filling.
Review and prepare labeling documents (labels, cartons, pack insert) according to US regulations.
Develop expertise in various therapeutic areas such as Cardiology, Diabetology, Neurology, Ophthalmology etc.
Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
Ensure timely submission of applications to USFDA while maintaining high-quality standards.

Desired Candidate Profile

8-10 years of experience in Regulatory Affairs with a focus on US market.
Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma).
Strong understanding of dossier preparation guidelines for USFDA submissions.
Excellent communication skills for effective collaboration with internal stakeholders.

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Immacule Life Sciences

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