Regulatory Affairs Manager

Role & responsibilities

• Reviewing of documents received from Project Managers and then preparing and filling of dossiers for BE NOC/CT NOC/GCT/biosimilar Clinical trial as per New Drugs and Clinical trials rules 2019.
• Reviewing, preparing and filling of dossiers seeking Import License for Investigational Products for bio-studies/Clinical Trials for DCG(I) submission as per New Drugs and Clinical trials rules 2019.
• Export of biological samples of biostudies/Clinical Trials done in India for DCGI approval.
• Reviewing, preparing and filling of dossiers seeking approval from ICMR, New Delhi for import of biological samples for analysis purpose
• Reviewing, preparing and filling of dossiers for getting Import Certificate from Central Bureau of Narcotics, Gwalior for Narcotic and Psychotic drugs.
• Reviewing, preparing and submissions of SUSAR/SAE notifications as well as Annual progress reports of Global Phase II oncology Clinical Trials/regular bio-studies.
• Coordinating with Consultant at Delhi pertaining to DCGI Office/ICMR related submissions and approvals.
• Advise to Business Development team/Project Management Team and other concerned personnel pertaining regulatory related issues and also providing updates regarding changes done in the guidelines, notifications, amendment etc. time to time.
• Maintaining of the records of each application/ notification/ amendment /etc. and regulatory related documents.
• On weekly basis update regulatory application status file and forward the same to management/Project Managers/etc.
• Forward inward copy or approval copy to respective Project Managers.
• Coordinating and assisting to management and departmental Heads for regulatory related matters.
• Dissemination of information/news/updates related to Indian Regulation within company.
• Responsible for team development by mentoring and training.
• Responsible for approval of individual employees performance goals.
• Ensure the safety and well-being of departmental employees and provide assistance to resolve employee grievances.
• Support and help resolve inter and intra departmental issues for achieving organizational objectives.
• Responsible to manage departmental work in absence of reporting manager.
• Responsible to approve leaves and attendance of team member.
• Reward and Appreciate employees to boost their morale
• Keep a check on departmental attrition and make efforts in reducing the same.
• Responsible to manage departmental work in absence of reporting manager.
• Any other task given by reporting authority.