▷ [Only 24h Left] Head Regulatory Affairs (india)

4 weeks ago

Gurgaon Haryana, India Sun Pharmaceutical Industries Full time

Reporting to Sr Vice President - Regulatory Affairs Qualification Master s Degree in Pharmacy PhD in Pharmacology or Pharmaceutics desirable Experience 10 years Location Baroda Mumbai Responsibilities Work with various cross-functional teams within the organization to ensure that availability of a development execution and submission pathway for submission of products for India market ensuring first time approval first mover advantage Develop optimum regulatory pathway for product approval to ensure competitive advantage for new drugs FDC devices neutraceuticals etc Participate and provide regulatory guidance to development and other teams during the development to ensure right data is generated and presented in the submission Provide regulatory guidance for protocol design for clinical studies that are cost efficient and productive Participate in SEC and other related discussions to represent regulatory view point Support manufacturing plants during inspections Provide support to life cycle management and business continuity for current products such as transfers Work with CROs CMOs to support out sourcing by providing regulatory inputs Ensure procurement and renewal of Licenses of all locations for the outsourced products Ensure regulatory compliances at Company s warehouses and godowns Work with IP commission NIB Central and State Laboratories for company related issues Draft and submit appropriate justifications and representation to State and Zonal offices Central HQ in cases of NSQ issues reported in monthly drug alert Technical Skills Thorough understanding of applicable rules and regulations including Indian Drugs Cosmetics Act Medical Device NDCT Rules Nutraceutical and other regulations Regulatory understanding of licensing requirements as applicable for development and commercialization of products in India Familiarity of Indian systems impacting regulatory workflows Familiarity with licensing authorities in India including CDSCO Understanding of different pharmaceutical dosage forms Personal Skills Negotiation skills Communication presentation - written and verbal Attention to detail Willingness to challenge the status quo and ask questions Curiosity The ability to listen and learn Able to view issues from a holistic perspective Passionate and proactive Time management Problem solving Ability to work in large teams and lead a team

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