Job
Description
Key Responsibilities: - Develop and implement global regulatory strategies to ensure product approvals and - Market access across multiple regions (FDA, EMA, MHRA, TGA, and Health Canada). - CMC expert in handling the Initial Submissions and Life cycle management activities for the Global Regulatory for US, Europe, Canada, Australia, China and Emerging Markets for OSD’s, Ophthalmic, Complex Injectable and Liposomal Dosage forms. - Author high-quality CMC documentation (Dossiers and Deficiencies responses) applying agreed CMC regulatory strategies, assuring technical congruency and regulatory compliance. - Led cross-functional teams for new product development, regulatory submissions, and post-approval activities. - Ensure compliance with international regulatory standards and manage audits and inspections by global Health authorities. - Provide regulatory intelligence and strategic advice to senior management on evolving regulations and their business impact. - Collaborate with R&D, Quality, and Marketing teams to align regulatory activities with overall business goals. - Compilation and submission of Controlled correspondence, Pre-submission meeting requests, and scientific advice for the US, Canada, and EU markets. - Evaluation of pre-PIF and provide the regulatory submission requirements for all the US & EU extended approved for AUS, Canada, and EU markets. - Set regulatory strategies for implementing changes worldwide to ensure business continuity and a successful Day 1 product launch in Europe, Canada, Australia, the UK, and China (Type IA/IB/Type II supplements, Category 3 notifications). - Manage a Member regulatory affairs team, ensuring compliance with applicable regulations and standards for pharmaceuticals and biologics, including ANDA, NDA, DCP,CP and ANDS applications. - Regulatory evaluation of change controls and various other quality events (e.g. Deviations,OOS/OOT etc.) for possible regulatory impact. - Comprehensive knowledge of Regulatory Software -LIMS, Track-wise, Pharma redy Amplexor etc. Show more Show less
