Neoplus Translation & Neocubes Pharma
Website:
neocubespharma.com
Job details:
Company Description
At Neoplus Translation and its subsidiary Neocubes Pharma, we are committed to delivering tailored solutions to meet diverse client needs. Neoplus Translation, established in 2012, specializes in professional localization and translation services across 140+ languages, including European, Middle Eastern, Asian, African, and other regional languages. Neocubes Pharma focuses on providing comprehensive Regulatory and Pharmacovigilance services, including dossier submissions, safety monitoring, and GxP assistance, adhering to global compliance standards. We proudly hold ISO 9001:15001 certification and maintain a network of qualified auditors to ensure excellence. Visit our websites NeoCubes Pharma and Neoplus Translation for more details.
Role Description
This is a full-time on-site position based in Ahmedabad for the role of Regulatory Affairs Associate - Artwork. In this role, you will manage regulatory documentation, oversee compliance with applicable regulatory requirements, and ensure the timely and accurate preparation of regulatory submissions. Your responsibilities will include coordinating with teams to align on regulatory standards, collaborating during the dossier preparation process, and maintaining up-to-date knowledge of regulatory legislation to support internal and client needs.
Qualifications
- Proficiency in Regulatory Documentation, including the preparation, review, and management of technical files and records
- Comprehensive understanding of Regulatory Requirements and Compliance for regional and international standards
- Experience handling Regulatory Submissions, ensuring prompt and accurate filing to relevant authorities
- Expertise in Regulatory Affairs, including managing global regulations and compliance challenges
- Excellent organizational and cross-functional collaboration skills
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field
- Familiarity with artwork development and its alignment with regulatory standards is a plus
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