API Regulatory Professional

RL Fine Chem (RLFC)

10 - 15 years

12 - 17 Lacs

Bengaluru

Posted:2 days ago| Platform:

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Skills Required

API Regulatory eCTD regulatory documentation documentation US-FDA regulatory compliance EDQM

Work Mode

Work from Office

Job Type

Full Time

Job Description

MSc in Analytical / Organic Chemistry
Pharmacy
Life Science

Seeking detail-oriented and motivated regulatory compliance specialists to manage and coordinate regulatory activities related to API filings across multiple regions. Responsibilities include preparing, reviewing, and submitting high-quality regulatory documents to ensure global compliance.

Prepare, compile, and submit DMFs, ASMFs, and API regulatory dossiers to global authorities.
Ensure timely updates, maintenance, and life cycle management of submissions.
Monitor global regulatory changes and communicate to internal teams.
Handle customer queries, letters of access, and technical data packages.
Maintain database and tracking systems for submissions and commitments.
Support regulatory and customer audits across all sites.

Key Skills & Competencies:

Passion to make a difference combined with

Strong analytical and strategic thinking.
High attention to detail and ability to manage multiple projects/filings.
Excellent written and verbal communication.
Experience with Electronic Submission System (eCTD).
Knowledge of pharmaceutical standards (USP, EU, JP).
Understanding of documentation and filing requirements (US-FDA, EDQM, ANVISA, PMDA, etc.).
Familiarity with ICH Q7, M7, Q11, Q12 guidelines.

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