Regulatory Affairs Specialist - API

As a Team Lead in Global Regulatory Affairs - API team at Dr. Reddys Laboratories Ltd., you play a crucial role in guiding and supporting your team in their operations. Your responsibilities include: - Defining regulatory requirements for the selection of Drug Master File starting materials and their suppliers - Guiding the teams in setting specifications for the starting materials, intermediates & Active Pharmaceutical Ingredient - Providing inputs for defining the control strategy for PGIs, nitrosamines & other regulatory expertise required - Ensuring smooth execution of regulatory filings globally according to the established plan - Monitoring and assessing the progress of Drug Master File (DMF) preparation - Developing submission strategies for alternate synthetic processes/sites - Ensuring comprehensive and timely responses to regulatory queries from various geographies - Aligning the Drug Master File (DMF) with regulatory standards of various countries - Facilitating collaboration with the front-end team for a robust submission plan - Conducting periodic reviews of team members to track progress and intervene when necessary Qualifications required for this role include: - Educational qualification: Post Graduate in Organic Chemistry/Pharma - Minimum work experience: 10-12 years in API Regulatory Affairs with a fair understanding of GMP & Quality systems Skills & attributes desired for this role: Technical Skills: - Knowledge of global regulatory requirements, new product development, manufacturing, quality & Intellectual Property Management - Understanding of geographic specific regulatory requirements - Thorough understanding of regulatory guidelines for United States/ Europe, ICH guidelines, pharmacopeia's, product filing and approval requirements Behavioral Skills: - Excellent communication and interpersonal skills - Efficient Leader and a good collaborator - Good influencing skills - Strong analytical and problem-solving abilities At Dr. Reddys, you will be part of the Integrated Product Development Organisation, committed to accelerating access to healthcare solutions worldwide. With a portfolio of more than 1,000 products and a robust R&D team, you will have the opportunity to drive innovation and make a positive impact on patients" lives. Dr. Reddys offers benefits such as personalised learning programs, joining & relocation support, family support, medical coverage, and life coverage for yourself and your family. The work culture at Dr. Reddys is centered around the belief that "Good Health Cant Wait", fostering a culture of empathy, dynamism, and shared success among employees.,