Job Title :
Regulatory Affairs Specialist
The primary responsibility of this role is to ensure compliance with international guidelines and country-specific regulations by preparing, reviewing, and maintaining regulatory documents.
About This Role :
This position involves collaboration with internal teams and external stakeholders to support product registrations, timely dossier submissions, query responses, and adherence to regulatory standards.
Required Skills and Qualifications :
- A graduate or postgraduate degree in pharmacy, life sciences, biotechnology, or a related field.
- 3–6 years of experience in regulatory affairs, preferably in pharmaceuticals, biotechnology, or healthcare.
- Strong understanding of global regulatory guidelines and dossier preparation.
Responsibilities :
Screening and analyzing documents received for product registration requests according to country-specific guidelines.Preparing, compiling, and reviewing product dossiers in compliance with customer and regulatory requirements.Prioritizing dossiers to meet defined timelines and ensuring timely submission to the regulatory authorities.Drafting and coordinating responses to regulatory queries with appropriate documentation and justifications.Arranging supportive batch-related documents for registration samples.Managing legalization or apostillation of registration documents, including coordination with agencies, tracking timelines, and processing payments / invoices.About the Position :
This role offers an exciting opportunity to work in a dynamic environment where you will be responsible for ensuring the accuracy and completeness of regulatory documents.