Regulatory Affairs Specialist

We are seeking a detail-oriented Regulatory Affairs Specialist to join our team in Rajasthan. The ideal candidate will have a strong background in regulatory affairs, particularly within the pharmaceutical industry, and will be responsible for ensuring compliance with regulatory requirements related to active pharmaceutical ingredients (APIs) and their manufacturing processes. Key Responsibilities: - Review and manage regulatory documentation to ensure compliance with local and international regulations. - Collaborate with cross-functional teams to prepare and submit regulatory filings, including new drug applications and variations. - Conduct vendor document reviews to ensure that all materials meet regulatory standards. - Stay updated on changes in regulatory requirements and communicate these changes to relevant stakeholders. - Assist in the development and implementation of regulatory strategies for new products. - Maintain organized records of all regulatory submissions and correspondence. Required Skills: - Strong knowledge of regulatory affairs and compliance in the pharmaceutical sector. - Experience with API manufacturing processes and documentation. - Excellent attention to detail and organizational skills. - Ability to work collaboratively in a team environment. - Strong communication skills, both written and verbal. If you are passionate about regulatory affairs and want to contribute to the pharmaceutical industry, we encourage you to apply for this exciting opportunity.