Regulatory Affair Manager Natural Biogenex Pvt Ltd

12.0 - 16.0 years

0 Lacs

karnataka

On-site

As the Regulatory Affairs Manager at Natural Biogenex Pvt. Ltd. (NBPL), you will be responsible for overseeing the regulatory submission processes, ensuring compliance with all applicable regulations, and managing the regulatory strategy for pharmaceutical products. Your role will involve working closely with various departments such as R&D, Quality Assurance, and Marketing to facilitate the development and commercialization of pharmaceutical products. Your key responsibilities will include developing and implementing regulatory strategies for drug development and approval, guiding regulatory requirements and compliance to internal teams, preparing and submitting regulatory documents to health authorities, managing communication with regulatory authorities, monitoring changes in regulations to ensure compliance, working collaboratively with cross-functional teams, managing multiple regulatory projects simultaneously, and maintaining accurate records of regulatory submissions and communications. To excel in this role, you should possess a Bachelor's or Master's degree in pharmacy, along with a minimum of 12 - 15 years of experience in regulatory affairs within the pharmaceutical industry for filing products in various regulatory agencies. You should have a strong understanding of regulatory guidelines and compliance requirements (such as FDA, EMA, etc.), excellent communication, organizational, and project management skills, and the ability to work collaboratively in a fast-paced environment. By joining Natural Biogenex Pvt. Ltd., you will have the opportunity to be a part of a leading API manufacturing company with cutting-edge technology and compliance standards. You will work in a state-of-the-art Quality Control Laboratory with global regulatory standards, contribute to regulatory audits and pharmaceutical quality excellence, and benefit from competitive salary and professional development opportunities.,

Posted 3 days ago

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