Executive - Regulatory Affairs

Be the First to Apply Division Piramal Critical CarePiramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.   PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.   PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.  For more details, please visit https://www.piramalcriticalcare.com/global/  Job Title Executive - Regulatory AffairsJob Description To support all products submissions including new applications, variations and renewals to ensure supplies to the EU & RoW markets in accordance with government legislation, relevant guidelines and national requirements.Business: Piramal Critical Care Department: Regulatory Affairs Location: Kurla Travel: Low Key stakeholders External - External (Country Distributors, Health Authorities (HA), external partners, CMO's) Internal - Internal (Cross-Functional): Sales, Marketing, Manufacturing, Supply Chain, Medical Affairs, Quality Assurance, Quality Control, Pharmacovigilance, Planning, Program Management, Artwork & Labeling Team Essential Qualifications & Experience M. Pharm/B. Pharm/MSc or equivalent in a relevant scientific discipline Minimum 2 to 4 years of relevant experience in handling European markets and/or in Rest of World territories. Roles and Responsibilities Preparation and submission of regulatory documentation for new marketing authorisations, variations and renewals for assigned products and/or markets Prepare and review all new applications and other submissions including dossier components, SmPC's, labelling etc. for compliance with all applicable regulations, local procedures and guidelines for assigned markets Initiation of Change Controls in applicable systems for all regulatory driven change controls Act as liaison between single or multiple project teams to obtain submission related information Author response packages to Requests For Information (RFI) received from Health Authorities in accordance with internal timelines and HA imposed deadlines Review and approve response packages to Requests For Information (RFI) received from Health Authorities in accordance with internal timelines and HA imposed deadlines