Regulatory Affairs Manager (APIs) : Global

Company Description

Nectar Lifesciences Ltd. (NLL) is a knowledge-driven organization that plays a vital role in the rapidly growing Indian Pharmaceutical Industry. NLL is ranked among the top midsized pharmaceutical companies in India and is one of the leading API manufacturers. The company has gained a strong position in the global Cephalosporins industry within the Anti-Infective Therapeutic segment, with business operations in nearly 45 countries. NLL operates 11 state-of-the-art manufacturing facilities in Punjab and Himachal Pradesh, adhering to global cGMP, EHS standards, and employs a highly skilled and competent workforce. NLL is a publicly traded company with a subsidiary in Portugal.

Role Description

This is a full-time on-site role for a Regulatory Affairs Manager (APIs): Global. The position is located in Dera Bassi. The manager will be responsible for ensuring regulatory compliance and meeting regulatory requirements, preparing and submitting regulatory submissions, managing quality systems, and overseeing regulatory affairs. The role involves staying updated with global regulatory guidelines, collaborating with cross-functional teams, and ensuring that all API products meet regulatory standards.

Qualifications

• Regulatory Compliance, Regulatory Requirements, and Regulatory Affairs skills
• Experience with Regulatory Submissions
• Knowledge of Quality System management
• Excellent written and verbal communication skills
• Strong attention to detail and the ability to work both independently and collaboratively
• Bachelor's degree in Pharmacy, Chemistry, or a related field
• Experience in the pharmaceutical industry is a plus
• Proficiency in global regulatory guidelines and standards