Regulatory Affairs Specialist

We are seeking a detail-oriented Regulatory Affairs Specialist to join our team in Maharashtra. The ideal candidate will have a strong background in regulatory affairs, particularly in the preparation of Common Technical Documents (CTD) and dossier preparation. This role is crucial for ensuring that our products meet all regulatory requirements and are compliant with industry standards. Key Responsibilities: - Prepare and submit regulatory documents, including CTDs and other necessary dossiers, to health authorities. - Collaborate with cross-functional teams to gather and analyze data required for regulatory submissions. - Maintain up-to-date knowledge of regulatory requirements and guidelines to ensure compliance. - Assist in the development and implementation of regulatory strategies for new and existing products. - Communicate with regulatory agencies and respond to inquiries regarding submissions. - Support audits and inspections by regulatory authorities. Required Skills: - Strong understanding of regulatory affairs processes and requirements. - Experience in preparing CTDs and regulatory dossiers. - 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 are looking to contribute to a dynamic team, we encourage you to apply for this exciting opportunity.