Provis Biolabs is a energetic biotechnology company specializing in animal-origin-free bioreagents for pharmaceutical and biopharmaceutical applications worldwide. Established in 2019, we have developed and commercialized 10 products and continue to expand our product pipeline to address critical unmet needs in life sciences research and therapeutic development. With certifications like WHO-GMP, GLP, ISO 9001:2015, Halal, and Kosher, we provide high-quality, scalable solutions backed by robust R&D; and state-of-the-art GMP manufacturing capabilities. Our offerings include fermentation-based development and manufacturing services for areas such as vaccines, biologics, monoclonal antibodies, and cell and gene therapy products. At Provis Biolabs, we are committed to improving health and the environment through innovative and sustainable approaches.
Role Description
This is a full-time, on-site position based in Hyderabad for a Regulatory Affairs Specialist. The Regulatory Affairs Specialist will manage regulatory documentation, prepare and submit regulatory submissions,
and ensure compliance with global regulatory standards and requirements. Responsibilities include collaborating with R&D; and manufacturing teams, monitoring and interpreting regulatory guidelines, and providing expertise to ensure adherence to compliance standards.
Qualifications
- 3-5 Years Experience in Regulatory Documentation and Regulatory Submissions
- Comprehensive knowledge of Regulatory Compliance and Regulatory Affairs practices
- Understanding of Regulatory Requirements applicable to biopharmaceutical products
- Strong organizational skills and attention to detail in preparing accurate documentation
- Proven interpersonal and communication skills to collaborate with cross-functional teams
- Bachelor's or advanced degree in Regulatory Affairs, Life Sciences, Pharmacy, or a related field
- Prior experience working in a GMP-certified or biotechnology manufacturing environmen