Deputy Manager - Regulatory Affairs; API

Position: 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
Next Gen 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, docu Bridge,
Veeva