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Umedica Labs
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Manager/Sr. Manager - Regulatory Affairs - US Market

Manager/Sr. Manager - Regulatory Affairs - US Market

Umedica Labs

12 - 15 years

10 - 18 Lacs

navi mumbai

Posted:6 hours ago| Platform:

Apply

Skills Required

regulatory affairs anda sterile nda injectables manage query responses liquid post-approval submissions

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Regulatory Submissions:

Lead end-to-end preparation and submission of ANDA and NDA dossiers to the USFDA
Manage query responses, amendments, and post-approval submissions (PAS, CBE, Annual Reports)
Ensure compliance with current USFDA regulations and guidance documents

FDA Interactions:

Prepare and submit FDA meeting requests and meeting packages (Type B, C meetings)
Participate in and support FDA meetings as the regulatory lead
Handle Controlled Correspondence with the FDA for product development and regulatory strategy

Product Expertise:

Provide regulatory support for
complex formulations
, including
injectables and liquid dosage forms
Collaborate with R&D, QA, QC, and manufacturing teams to ensure regulatory alignment throughout the product lifecycle

Leadership & Communication:

Lead a team of regulatory professionals, providing guidance, training, and performance management
Communicate effectively with internal stakeholders and external regulatory bodies

Preferred candidate profile

Masters degree in Pharmacy
12–15 years of experience in US Regulatory Affairs with a proven track record in ANDA/NDA submissions
Hands-on experience with FDA meetings, Controlled Correspondence, and post-approval changes
Strong understanding of injectables, liquid dosage forms, and complex generics
Excellent written and verbal communication skills
Demonstrated leadership and team management capabilities

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