Company Description TRUGEN PHARMACEUTICALS PRIVATE LIMITED is a pharmaceutical manufacturing company based in Roorkee, Uttarakhand, India. With a vast manufacturing area and high production capacity, the company specializes in producing tablets, capsules, and oral liquids. TRUGEN serves over 650 clients, including major MNCs and engages in both Indian third-party contract manufacturing and international export business. Known for its timely delivery and quality products, TRUGEN offers a broad range of expertise in fields such as cardiac, diabetic, nephrology, orthopedics, and neuropsychiatry. The company is committed to ensuring the highest quality and client satisfaction. Role Description This is a full-time, on-site role located in Roorkee for a Regulatory Affairs Specialist. The Regulatory Affairs Specialist will be responsible for preparing, reviewing, and submitting regulatory documentation, ensuring regulatory compliance, and meeting all regulatory requirements. The Specialist will also manage regulatory submissions and maintain up-to-date knowledge on regulatory affairs. Day-to-day tasks include liaising with internal and external stakeholders, providing regulatory guidance, and ensuring timely approvals and renewals of products. Qualifications Regulatory Documentation and Regulatory Submissions skills Knowledge of Regulatory Compliance and Regulatory Requirements 4+ years Experience in Regulatory Affairs Bachelor's degree in Pharmaceutical Sciences Excellent communication and organizational skills Ability to work independently and as part of a team Experienced in the pharmaceutical industry