Manager- Regulatory Operations

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Be the First to Apply Division Piramal Critical Care Piramal 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 Manager- Regulatory Operations Job Description Business: Critical Care Department: Regulatory Affairs Location: Kurla, Mumbai Travel: LowJob Description Business: Critical Care Department: Regulatory Affairs Location: Kurla, Mumbai Travel: Low Job Overview: - Manage the team of Publishing expert(s), Manage the preparation, review, and submission of various electronic applications to the Food and Drug Administration (FDA), European Union (EU) and other regulatory bodies in accordance with government legislation, relevant guidelines, standards and national requirements. - Provides guidance, supervision and leadership of subordinates. - Support the vision for Regulatory Operations into the future Key Stakeholders: Internal: Cross-Functional: Regulatory New Products Team, Regulatory Life Cycle Management Team, Medical Affairs, Pharmacovigilance, Program Management Key Stakeholders: External: Health Authority (HA) Reporting Structure: Associate Director, Regulatory Operations Essential Qualifications: - B. Pharm or equivalent in a science or related field preferred. - Experience with document management systems and publishing software (tools) to support paper and electronic submission publishing. Other RIMS system knowledge. - Experience with Lorenz DocuBridge essential. - Working knowledge of eCTD structure, VNeeS, CVM application - Knowledge of Regulatory systems such as RIMS - Previously managerial experience and mentoring of junior staff - Must effectively multi-task, establish priorities and work in a fast-paced environment. - Must demonstrate ability to interact with management. - Possess excellent written and verbal communication abilities. Essential Experience: - 5 to 10years or more relevant regulatory publishing experience in US & Europe including the EU. - Experience in Canada, Australia and other Rest of World markets is desirable. Key Roles/Responsibilities: - Manage the team of Publishing experts - Lead and drive all publishing activities (planning, assigning, reviewing, coordination & submission) for assigned projects/products - Publish and review Electronic Submission packages of New registration dossiers, Post Approval submissions in eCTD format and dispatch through Electronic Submissions Gateway (ESG), Common European Submission Portal (CESP) or equivalent submission portal. - Publish and review the Veterinary product submission for US and EU region. - Documents Processing as per eCTD requirements for US, EU, TGA or relevant countries. - Ensure all publishing software meets the eCTD version requirements - Stay up to date with the latest rules and regulations - Manages compilation and submission of Periodic Adverse Event Reports for US and EU. - Perform quality checks for document integrity and compliance to regulatory standards. - Troubleshoot documents/eCTD publishing issues and provide guidance to company employees on best practices and regulatory requirements. - Knowledge of Baseline submission and basic requirements of Baseline submission. - Monitors the current eCTD requirements for USFDA, EMEA and other eCTD countries. Provides feedback to business on changes and impact/updates required to ensure Piramal remains compliant and competitive with regards the relevant systems. - Provide input and guidance and advice in Regulatory Operations activity such as system(s) upgrades, new system selection and implementation. - Develop User Requirements Specifications, Requests for Proposals in conjunction with the Director/Associate Director - Provide input and guidance to all new Regulatory Systems such as EDMS. RIMS etc to ensure consistency and compatibility with existing systems e/g. Docubridge - Design approaches to the automation of processes such as notifications of submissions and approvals - Contribute the overall aims of the Regulatory Operations team by providing input in

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