Lead, Regulatory Affairs

Job Description

Job Responsibilities: Mapping of regulatory requirements for functioning of R&D premise. Conduct regular gap assessments to identify new regulatory requirements (if any) with regards to functioning of the R&D premises and monitor compliance. Ensure compliances to applicable acts and rules viz. Drugs & Cosmetics Act, 1940 and Rules 1945, Medical Device Rules, 2017 and others. Identify and support the warehouse licensing requirements (including registration certificate for warehouse) Work with R&D teams to identify the requirements for test licenses for importing products for test, evaluation, demonstration or training. Strategize, plan and compile test license application and follow up with CDSCO for approval. Collaborate with R&D teams to provide regulatory guidance throughout the product development. Continuous scanning of the regulatory environment and communication to the R&D team on any new/changing regulations along with impact assessment and mitigation. Support R&D team for recognition of in-house R&D units RDI) from Department of Scientific and Industrial Research (DSIR). Collaborate with R&D QA team to establish and streamline internal processes. Support internal audits and inspections by external agencies (CDSCO/State FDAs/etc.). Coordinate with sourcing and warehouse team for importation of goods for R&D purpose and regulatory clarification to ADC/customs, wherever required. Compilation of Medical Device Dossier w.r.t Indian regulatory requirements for Registration, License Transfers, Import License, New Product Approvals, Renewals Regular follow-ups with CDSCO Work with other regulatory authorities like Atomic Energy Review Board (AERB), Department of Telecommunication (DoT), Legal Metrology, etc. Addressing Technical Queries both from regulators and internal stakeholders Change Management including tracking and submission of product/ site changes Applies understanding of business acumen and stakeholder management to accomplish the project Uses prescribed guidelines or policies in analyzing situations and resolving problems to deliver continuous business results Skills required: Good English Communication Skills - Verbal and Written Problem solving Stakeholder management Software Skills: MS Office Qualification: Graduate/Postgraduate in any life sciences/Engineering Experience : 7-8 years