Website:
unimedicolabs.com
Job details:
Company Description
Uni Medicolabs, established in 2009, is a leading pharmaceutical Contract Development & Manufacturing Organization (CDMO) in India, providing end-to-end solutions for global pharmaceutical and biotech companies. With three state-of-the-art manufacturing facilities compliant with international regulatory standards such as WHO-GMP and EU-GMP, the company delivers quality, scalable, and cost-effective drug development and manufacturing services. Uni Medicolabs specializes in a wide range of formulations, including oral solids, liquids, semi-solids, and complex generics, supporting clients throughout the entire product lifecycle. With a customer-centric approach, the company partners with clients across Asia, Europe, Africa, and Latin America to deliver innovative, high-quality medicines. A passionate team of experts drives its mission to improve patient lives by optimizing pharmaceutical solutions.
Role Description
This is a full-time, on-site role for a Drug Regulatory Affairs Executive based in Dehradun. The primary responsibilities include preparing and reviewing regulatory dossiers, ensuring compliance with regulatory requirements, coordinating with internal teams for documentation, and submitting applications to meet market-specific regulations. The position requires staying updated on global regulatory frameworks, supporting product registrations, and maintaining records of regulatory submissions. Additionally, the role involves providing regular updates on project status to stakeholders and collaborating to resolve regulatory queries effectively.
Qualifications
- Proficiency in Regulatory Documentation and Dossier Preparation
- Thorough understanding of Regulatory Requirements and Compliance
- Experience in Regulatory Affairs with attention to detail and accuracy
- Excellent organizational and communication skills
- Bachelor’s degree in Pharmacy, Life Sciences, or a related field (Master’s degree preferred)
- Knowledge of international regulatory standards is advantageous
- Ability to work effectively in cross-functional teams
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