Regulatory Affairs Manager Full Time

Urgent Hiring: Manager – Drug Regulatory Affairs (ROW Market)

Experience: 4 to 6 Years 

Education: B.Pharm / M.Pharm

Job location : Ahmedabad Gujarat Satellite

Market : ROW

Type of Industry : Pharmcetucial CDMO

Role Overview:

We are seeking an experienced Regulatory Affairs Manager to lead and manage regulatory activities for Rest of the World (ROW) markets. The role involves ensuring compliance with international regulatory guidelines, managing dossier submissions, and coordinating with cross-functional teams to support product lifecycle management.

Key Responsibilities:

Ensure compliance with regulatory guidelines for ROW markets.

Prepare, review, and ensure timely submission of dossiers to regulatory authorities across Asia, Africa, and LATAM regions.

Collaborate with R&D, Quality Assurance, Manufacturing, and Legal teams to ensure adherence to regulatory requirements throughout the product lifecycle.

Maintain up-to-date knowledge of international regulatory frameworks and implement necessary updates in documentation and processes.

Support product registration, renewals, and post-approval changes in assigned markets.

Liaise with external stakeholders and regulatory agencies to facilitate smooth approval processes.

Desired Profile:

Strong understanding of global regulatory guidelines and dossier compilation requirements.

Proven experience in handling submissions for ROW markets (Asia, Africa, LATAM).

Excellent coordination, communication, and documentation skills.

Detail-oriented with the ability to manage multiple projects and deadlines.

Interested candidates kindly send us their resume to mugdha.v@entirety.org.in