Regulatory Affairs

0 - 5 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Uniza Lifecare Pvt. Ltd.

time outline icon Mehsana, Gujarat, India

Posted on 29-01-2025

1 Vacancy

Description

Preparing and submitting regulatory documents for product approvals, including applications, licenses, and registrations to regulatory agencies.
Ensuring compliance with local, regional, and international regulations and standards governing the product development lifecycle.
Reviewing and interpreting regulations, guidelines, and industry standards to ensure compliance with product labeling, advertising, and marketing materials.
Coordinating with internal teams, including R&D, Quality Assurance, and Production, to ensure that products meet regulatory requirements at every stage.
Maintaining up-to-date knowledge of changes in regulatory policies and advising management on potential impacts.
Managing the approval process for new products, including conducting pre-market assessments and ensuring timely submission of required documentation.
Ensuring regulatory compliance during clinical trials, product launches, and post-market surveillance.
Preparing responses to queries from regulatory authorities and conducting follow-up communications.
Ensuring proper maintenance and archiving of regulatory documents, ensuring easy retrieval during audits and inspections.