Drug Regulatory Affairs Manager - API

Tds Placements; Dera Bassi; On-site; INR 600,000 - 900,000; Full time

Benefits offered by this job

Thanks

Ravin Thakur

Job summary

TDS Placements in Punjab is seeking a regulatory affairs professional to prepare, review and compile dossiers for API products.

You'll handle global submissions, including DMFs and CEPs, and ensure CTD/eCTD documentation meets ICH and GMP standards. Prior experience with DMF/ASMF is a plus; strong attention to detail is essential.

Join a dedicated team where accuracy and compliance drive consistently successful registrations across global markets.

Qualifications

• Strong knowledge of API regulatory requirements for global markets.
• Experience in preparation and submission of DMF/ASMF/CEP and other regulatory dossiers.
• Knowledge of ICH guidelines, GMP, CTD/eCTD

Responsibilities

• Preparation, review, and compilation of regulatory dossiers for API products.
• Handling global regulatory submissions including DMFs and other registration dossiers.
• Documentation in CTD/eCTD format.

Skills

DMF/ASMF/CEP submission

CTD/eCTD

ICH guidelines

GMP knowledge

Regulatory submissions

Education

B.Pharm/M.Pharm

Job description

Preparation, review, and compilation of regulatory dossiers for API products.

Handling global regulatory submissions including DMFs and other registration dossiers.

documents in CTD/eCTD format.

Required Candidate profile

• Strong knowledge of API regulatory requirements for global markets.
• Experience in preparation and submission of DMF/ASMF/CEP and other regulatory dossiers.
• Knowledge of ICH guidelines, GMP, CTD/eCTD

Perks and benefits

• Thanks
• Ravin Thakur