Deputy Manager - Regulatory Affairs (API)

Key Responsibilities:

Drug Master File (DMF) Management

• Prepare, review, and submit DMFs in compliance with global regulatory

requirements including US (FDA), EU (ASMF and CEP), Canada, China, Korea, Brazil,

and emerging markets.

• Maintain and update DMFs throughout their lifecycle, including change filings and

regulatory correspondence.

Regulatory Strategy & Compliance

• Develop and implement regulatory strategies for generic synthetic, semi-synthetic,

and peptide APIs.

• Ensure all submissions meet statutory and regulatory standards across regions.

Deficiency Response Handling - Prepare responses to the deficiencies received from

customers and agency, ensuring clarity, completeness, and compliance with their

expectations.

Electronic Submissions - Prepare and submit dossiers using eCTD format via CDER

NextGen portal and CESP gateway.

Cross-Functional Collaboration - Collaborate with internal stakeholders like R&D, QC,

QA, Production to align regulatory strategies with business goals and expedite approvals

for critical changes.

Guideline Adherence - Stay updated and ensure compliance with USFDA, EMEA, CEP, and

ICH guidelines.

Technical Document Review - Through review of the documents received from the cross-

function teams as per the statutory requirements of agency.

Regulatory Database Management - Utilize Veeva RIM and document management

systems for regulatory data management and tracking submissions.

Communication and Soft skills - Candidate should have good communication skills

(spoken and written) for internal and external coordination with customers. Candidate

should be able to work and communicate independently with internal/external clients in

most of the matters.

Qualifications: B. Pharma / M. Pharma or M.Sc. in Organic Chemistry

Experience: Minimum 10 years in API Regulatory Affairs

Add-ons: Well versed with MS PowerPoint, word, excel, Visio, MS Teams, docuBridge,

Veeva