Regulatory Affairs Specialist

3 - 8 years

5 - 8 Lacs

Posted:1 month ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

About the Role: As a Regulatory Affairs Specialist, you will play a crucial role in ensuring that our products comply with all applicable regulations and standards. You will work closely with various departments to prepare and submit regulatory documents, manage communications with regulatory agencies, and keep abreast of the latest regulatory requirements. Key Responsibilities: Monitoring authorities websites for updates and regulatory requirements. Creating product information, including EU Common Submission Information (EUCSI), Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL), and labels. Providing support for user testing of product information. Preparing dossiers for regulatory submissions, including eCTD format. Conducting compliance audits and drafting detailed audit reports. Drafting documentation for EU regulatory procedures, such as Decentralized Procedure (DCP), Mutual Recognition Procedure (MRP), and Centralized Procedure (CP). Performing life-cycle maintenance tasks, including safety variations, XEVMPD updates, and preparation of protocols for user testing. Maintaining and comparing core product texts to ensure consistency and compliance. Training the team on regulatory processes and industry best practices. Undertaking any additional services mutually agreed upon in writing. Preferred Qualifications: Bachelor s degree in a scientific discipline (e.g., Biology, Chemistry, Pharmacy) or a related field. Minimum of 3 years of experience in regulatory affairs, preferably within the [specific industry, e.g., pharmaceutical, medical device, biotechnology] sector. Strong knowledge of regulatory requirements and guidelines (e.g., EMA, ICH). Excellent written and verbal communication skills. Attention to detail and strong organizational skills. Ability to work independently and as part of a team. Proficiency in Microsoft Office Suite and regulatory databases.

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