Deputy Manager - Regulatory Affairs (API)

UpMan Placements; Thane; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

A reputable placement agency is seeking a seasoned Regulatory Affairs professional located in Thane, Maharashtra, with a minimum of 10 years of experience in API Regulatory Affairs. The role involves preparing DMFs for global regulatory submissions, developing compliance strategies, and collaborating cross-functionally. Candidates must hold a B. Pharma, M. Pharma, or M.Sc. in Organic Chemistry and possess strong communication skills. Experience with Veeva RIM and other MS Office tools is essential.

Qualifications

• Minimum 10 years of experience in API Regulatory Affairs.
• Good communication skills for both internal and external coordination.
• Ability to work independently and communicate effectively with clients.

Responsibilities

• Prepare, review, and submit DMFs in compliance with global regulatory requirements.
• Develop and implement regulatory strategies for various API types.
• Ensure compliance with USFDA, EMEA, and guideline adherence.

Skills

Regulatory compliance

Communication skills

Cross-functional collaboration

Education

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

Tools

Veeva RIM

MS PowerPoint

Excel

Job description

• 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.

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,