Senior Manager/Manager/DM/AM/Senior Executive - Regulatory Affairs

Shilpa Medicare Limited

5 - 10 years

10 - 20 Lacs

raichur

Posted:5 hours ago| Platform:

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Skills Required

regulatory compliance usfda regulatory affairs row market gmp compliance us dmfs

Work Mode

Work from Office

Job Type

Full Time

Job Description

1. Senior Manager/Manager -

Required:

Qualifications:

Key Responsibilities:

Lead API regulatory strategy, including preparation and submission of US DMFs, EU ASMFs/CEPs, and filings for Japan PMDA/KFDA.
Oversee team (5-10 members) for pre-approval inspections, audit responses, and post-approval changes/variations.
Manage stability programs, OOS/OOT investigations, and QMS compliance per FDA/EMA guidelines.
Collaborate with R&D, QA, and manufacturing for regulatory intelligence and gap assessments.
Handle agency queries, renewals, and risk assessments for oncology/specialty APIs.

2. Assistant Manager -

Experience Required:

Qualifications:

Key Responsibilities:

Compile and review API dossiers in eCTD/ACTD formats for RoW markets, including labeling, stability data, and impurity profiles.
Prepare and submit regulatory filings for non-US/EU regions (e.g., Canada, LATAM) and support CEP applications.
Ensure GMP compliance in documentation; conduct internal audits and CAPA implementation.
Coordinate with cross-functional teams for tech transfer and query resolutions.
Monitor regulatory updates and maintain filing timelines.

3. Senior Executive -

Experience Required

Qualifications:

Key Responsibilities:

Assist in API regulatory documentation: test methods, specifications, and worksheets per ICH/FDA guidelines.
Support DMF/ASMF module preparation, including analytical method validation and stability summaries.
Maintain LIMS records, prepare trends/reports, and contribute to audit readiness.
Handle basic query responses and variation filings; ensure accurate record-keeping for submissions.
Participate in training on regulatory aspects and GMP adherence.

More Jobs at Shilpa Medicare Limited

Senior Manager/Manager/DM/AM/Senior Executive - Regulatory Affairs

raichur

5.0 - 10.0 yrs

INR 10 - 20 Lacs

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