SunGlow was incorporated in January 2010 and was founded by a group of experienced industry professionals. Our Corporate office is located in Chennai, India. The first facility located in Puducherry, a small state in the southern part of India, about 145 kilometres south of Chennai manufactures for the domestic market. The second facility is located in Chengalpattu, a town about 80 kilometres southwest of Chennai manufactures for the global market.
Post : Senior Manager - Regulatory Affairs
Job Description
• Responsible for the preparation and submission of dossier for Europe. Australia, ASEAN. LATAM and RoW countries.
• Review all regulatory submission documents to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
• Provide regulatory guidance to the Product development team in terms of RLI) selection, bioequivalence/bio-waiver requirements and dossier filing strategy.
• Coordination with site for preparing and checking of Artwork. SPC and PIL
• Coordinating and preparing tor site registration application for various countries
• Handling of queries/RFIs from Regulatory Authorities related to site and product registration.
• Handling of post-approval changes/variations.
• Handling of life-cycle management for the registered products.
• Implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
Candidate Profile
• Qualification : B.Pharm / M.Pharm
• Experience : 8-12 years of experience in reputed pharma companies with strong exposure in dossier preparation and submission for Europe. Australia. LATAM and ROW countries.
• Candidate should have good communication and technical writing skills.
Job Location : Chennai
Interested candidates can share CV at : hr_admin@sunglowlifescience.com
Last Date : 31st January, 2024
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