Regulatory Affairs Manager

Company Description

PSI is an award-winning full-service CRO, bringing together more than 2,700 dynamic and knowledgeable individuals working to help impact the future of medicine in more than 60 countries around the world. We support pharmaceutical, biotechnology, and medical device companies with the services needed to perform clinical trials of new medicines. Our work helps patients in need improve their well-being – a fundamental driver for many of us to show up and do our best each day.

Job Description

You will focus on leading regulatory services for global research projects of novel medicinal products in India while joining our global team of regulatory and ethics submissions experts. Join our team and contribute to groundbreaking clinical research. 

Office-based in Bangalore

• Oversee preparation of clinical trial submission dossiers for regulatory authorities in India, including Import and Export license applications
• Communicate with regulatory authorities, project teams and vendors on regulatory-related matters
• Develop and review project planning documents & processes, including study timelines for India
• Track changes/amendments to legislative acts pertaining to clinical trials in India and timely notification of all parties involved
• Develop and maintain regulatory requirements database
• Perform quality control of regulatory dossiers
• Ensures accurate and time-bound reporting of safety issues to local authorities
• Train PSI staff in regulatory aspects of clinical trials
• Mentor and train junior regulatory staff
• Participate in the regulatory aspects of feasibility research, support Business Development at client presentations and bid defense meetings

Qualifications

• University degree
• 5 years of hands-on experience with clinical trial submissions (independent preparation of submissions dossiers for DCGI, including preparation of application forms, Executive Summary, country-specific statement, as well as country-level customization of patient documents)
• Extensive experience in regulatory aspects of clinical research with profound knowledge of regulations pertaining to clinical trials in India
• Full working proficiency in English
• Proficiency in MS Office applications
• Ability to learn, plan and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills

Additional Information

You will work closely with driven and dedicated cross-functional teams, get all support and ownership of your projects. If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.