Regulatory Affairs Specialist

We are seeking a detail-oriented Regulatory Affairs Specialist to join our team in Rajasthan or Haryana. The ideal candidate will have a strong background in regulatory affairs and documentation within the pharmaceutical industry. This role is crucial for ensuring compliance with regulatory standards and facilitating the approval process for pharmaceutical products. Key Responsibilities: - Prepare and manage regulatory submissions, including Drug Master Files (DMF) and Certificates of Analysis (CoA). - Coordinate with vendors to ensure timely and accurate documentation and compliance with Good Manufacturing Practices (GMP). - Maintain up-to-date knowledge of regulatory requirements and guidelines to ensure compliance in all aspects of pharmaceutical documentation. - Collaborate with cross-functional teams to support product development and ensure regulatory compliance throughout the product lifecycle. - Conduct audits and assessments of regulatory documentation to identify areas for improvement and ensure adherence to industry standards. Required Skills: - Strong understanding of regulatory affairs and compliance in the pharmaceutical industry. - Experience with regulatory documentation processes, including API submissions and GMP regulations. - Excellent organizational and communication skills, with the ability to coordinate effectively with vendors and internal teams. - Detail-oriented with strong analytical skills to assess regulatory requirements and documentation accuracy. - Ability to work independently and manage multiple projects simultaneously in a fast-paced environment. If you are passionate about regulatory affairs and want to contribute to the success of our pharmaceutical products, we encourage you to apply for this exciting opportunity.