Team Lead Regulatory Affairs

The primary responsibility of this role is to manage Regulatory Affairs in compliance with relevant regulations and guidelines for the organization. As a Regulatory Affairs Manager at DDReg, you will be involved in reviewing clinical, biopharmaceutical, non-clinical, and labelling documentation. Your duties will include preparing and reviewing non-CMC sections, Variations, site transfers, and conducting post-approval gap analysis. Additionally, you will support the regulatory function through document management, electronic submission compilation, and other group management activities as needed. Collaboration with various departments such as Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, and Research and Development will be necessary to ensure regulatory compliance and operational excellence. Your responsibilities will involve providing high-quality reviews of CTD sections for regulatory filings to various regulatory authorities such as EMA, UK MHRA, National Agencies of EU Member states, Canada, Australia, and other markets globally. You will actively contribute to developing and implementing regulatory strategies, processes, and timelines for global approval. Conducting Gap Analysis of Non-CMC sections, authoring and compiling CTDs sections, preparing labelling documentation, managing labelling changes, and ensuring compliance with regulatory guidelines will be key aspects of your role. Furthermore, you will be required to demonstrate expertise in regulatory matters, collaborate with internal and external stakeholders, and provide technical consultation and advice on strategy and industry best practices. To excel in this role, you should possess a Bachelor's or Master's degree in Pharma and have at least 5+ years of relevant experience in the pharmaceutical/CRO industry. Strong project management skills, excellent interpersonal and communication skills, and in-depth knowledge of global regulatory guidelines are essential for success. Proficiency in Microsoft Word, PowerPoint, and Excel, along with the ability to work effectively in a team-oriented environment, are also crucial requirements. The ideal candidate should be adaptable, capable of working under pressure, and able to deliver high-quality results within tight timelines. This position is based in Gurgaon, Haryana, India. Occasionally, you may be required to work across different time zones to fulfill job requirements.,