Senior Manager - Regulatory Affairs

You are applying for the position of Senior Manager - Regulatory Affairs at Intas Pharmaceuticals. As a Regulatory Affairs professional, you will be responsible for managing regulatory activities related to solid oral dosage forms in markets such as EU, ANZ, Switzerland, and others. Your role will involve portfolio management, communication with cross-functional teams, and ensuring compliance with current ICH and EU regulatory guidelines. **Key Responsibilities:** - Planning and executing regulatory projects - Reviewing regulatory documents and providing commercial support when necessary - Compiling and reviewing dossier sections in EU CTD format for submission - Coordinating with various departments for document collection, archiving, and review - Supporting the publishing of dossiers and post-approval submissions in NeeS/eCTD format **Qualification Required:** - M. Pharm in Regulatory Affairs, Quality Assurance, or Pharmaceutics - 5 to 10 years of relevant experience in regulatory affairs **Relevant Skills and Competencies:** - Experience in EU CTD section compilations - Understanding of current regulatory guidelines (ICH and EU) and CMC documents - Knowledge of post-approval procedures and hands-on experience in post-approval submissions - Strong communication and interpersonal skills - Experience in publishing dossiers through eCTD software Intas Pharmaceuticals is a global pharmaceutical company known for its high standards of quality and commitment to innovation in healthcare. As an employee, you will be part of a dynamic environment where individual potential is nurtured, and collaboration is encouraged to drive collective success. Location: Head Office, Ahmedabad, GJ, IN, 380054 Travel: 0% - 25% Join Intas Pharmaceuticals to be a part of a team that values diversity, skills, and shared purpose to achieve remarkable outcomes in the pharmaceutical industry.,