B. Braun is one of the world's leading medical technology companies. With over 63,000 employees, the family-owned company is a true partner, developing smart solutions and setting standards to drive advancements in health care. B. Braun has subsidiaries in 64 countries who serve the different health care markets. We continuously develop our portfolio of more than 5,000 products and 120,000 articles. We have competence in numerous therapeutic areas and supply the healthcare market with products in areas like anesthetics, intensive care medicine, cardiology, extracorporeal blood treatment and surgery as well as with services for hospitals, general practitioners, and home care.
Manager Regulatory Affairs & Vigilance Delhi, India
The Regulatory Affairs (RA) team is responsible for ensuring our products meet legislative requirements, and that the public's health is protected by controlling the safety and efficacy of these products. Our RA team keeps track of the ever-changing legislation in all the regions of the country and ensure we can live our vision We Protect & Improve the Health of people around the World
Duties & Responsibilities
- Strategize submission of license variations and renewals to strict deadlines to ensure business continuity.
- Ensure that the Company's products and services comply with all applicable regulations and Acts including but not limited to Drugs and Cosmetic Act, Legal Metrology Act, NPPA Act, etc.
- Plan, co-ordinate, execute and monitor the timely approvals, registrations and renewals of the
- products manufactured and/or sold by the entities in India
- Monitoring and setting timelines for license variation and renewal / approvals and availing certificates as per the most recent guideline.
- Ensure that the entire process from initiation of registration to the preparation of info pack or labeling is completed
- Engage and resolve queries from regulators in order to secure permissions and approvals as per envisaged timeline
- Coordinate with other stakeholders for inputs and information needed to compete applications to regulatory authorities
- Review product dossiers before submission to regulators for product registration to minimize follow up queries
- Ensure archival/database maintenance of all registration related documents submitted to various authorities.
- Help prepare for and participate in all regulatory inspections
- Ensuring compliance of all applicable statutory, regulatory and company guidelines
- Keeping abreast of International Legislation, guidelines and customer practices
- To supervise and monitor the complaint management system and other activities/ submissions
- related to vigilance.
- Liasoning with the supply chain team for inventory and custom clearance related concerns.
Professional Competencies
- Masters in Microbiology, Bachelors in Pharmacy or Masters in Pharmacy
- Experience: Minimum 8-10 Years in Regulatory Affairs (MNC experience is mandatory) Personal Competencies
- Good oral and written communication skills
- Inter-personal skills
- Cross functional working
- Time management and Excellent organizational skills
- Focused and detail oriented
What we offer
Our promise is Sharing Expertise. The B. Braun company began with a passion for positive change. To this day, we attract people who express progressive ideas and implement them together with trust, transparency and appreciation. Because all follow the same vision: At B. Braun, we protect and improve the health of people worldwide.
Visit bbraun.com to know more!
To know more about B. Braun India you can visit our website https://www.bbraun.co.in/en.html
