Nabros Pharma
Website:
nabros.in
Job details:
Company Description Nabros Pharma Pvt. Ltd., established in 1983 and headquartered in Ahmedabad, Gujarat, India, is a globally recognized pharmaceutical company focused on research and development, advanced formulation, manufacturing, and strategic marketing. The company operates state-of-the-art, cGMP-compliant manufacturing facilities supported by robust quality assurance and strict SOPs to ensure product quality, integrity, and safety. Nabros Pharma’s WHO-GMP certified units are designed using Quality by Design (QbD) principles and regularly audited by international regulatory bodies, with ISO 9001:2015 certification reinforcing its commitment to global standards. Its diverse portfolio spans high-quality pharmaceuticals, nutraceuticals, and essential phospholipids for therapeutic and nutritional use. With a strong global distribution network, Nabros Pharma is dedicated to enhancing healthcare and quality of life worldwide through quality, innovation, and reliability.
Role Description This is a full-time, on-site Regulatory Manager role based in Ahmedabad. The Regulatory Manager will oversee regulatory compliance activities for pharmaceutical, nutraceutical, and related products, ensuring alignment with national and international regulations and guidelines. Daily responsibilities include preparing, reviewing, and coordinating regulatory submissions and dossiers, maintaining up-to-date knowledge of regulatory requirements, and managing interactions with regulatory authorities and certification bodies. The role involves collaborating with R&D, quality assurance, manufacturing, and marketing teams to integrate regulatory considerations into product development, labeling, and life-cycle management. The Regulatory Manager will also establish and update internal regulatory policies, support audits and inspections, and provide training and guidance on regulatory affairs to cross-functional teams.
Qualifications
- Strong knowledge of Regulatory Compliance and Regulatory Requirements relevant to pharmaceuticals and nutraceuticals, with the ability to interpret and apply guidelines to company processes.
- Experience in Regulatory Submissions and Regulatory Affairs, including dossier preparation, documentation management, and communication with regulatory authorities.
- Demonstrated Analytical Skills to review technical data, assess regulatory risks, and develop compliant solutions for product development and commercialization.
- Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related life science field.
- Hands-on experience in a regulatory role within the pharmaceutical or healthcare industry; familiarity with WHO-GMP, cGMP, QbD, and ISO standards is an advantage.
- Excellent written and verbal communication skills, with attention to detail and strong organizational capabilities.
- Ability to work collaboratively with cross-functional teams and manage multiple projects and deadlines effectively.
- Proficiency with documentation systems, MS Office tools, and basic regulatory information management systems.
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