- Responsible for the preparation and submission of dossiers for Europe, Australia, ASEAN, LATAM, and RoW countries.
- Review all regulatory submission documents to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
- Provide regulatory guidance to the Product Development team in terms of RLD selection, bioequivalence/bio-waiver requirements, and dossier filing strategy.
- Coordinate with the site for preparing and checking Artwork, SPC, and PIL.
- Coordinate and prepare site registration applications for various countries.
- Handle queries/RFIs from Regulatory Authorities related to site and product registration.
- Manage post-approval changes/variations.
- Handle life-cycle management for registered products.
- Implement regulatory affairs policies and procedures to ensure regulatory compliance is maintained or enhanced.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
Candidate Profile:
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Qualification:
B.Pharm / M.Pharm
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Experience:
8-12 years of experience in reputed pharma companies with strong exposure to dossier preparation and submission for Europe, Australia, LATAM, and ROW countries.
- Candidate should possess good communication and technical writing skills.
Job Location:
Chennai
Interested candidates can share their CV at: hr_admin@sunglowlifescience.com
Last Date:
31st January 2024
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