BD (Becton, Dickinson and Company) Deputy Manager, Regulatory Affairs in Gurgaon, India
Job Description Summary
Position Title Deputy Manager Regulatory Affairs Department Regulatory Affairs Location Reports to Head – Regulatory Affairs Qualification Post Graduate in Microbiology / Biochemistry / Pharmacy/ Bio Technology Experience 3 + Years experience in handling Medical Device RA (Preferably in US MNC) Position Summary Responsibility for managing Regulatory Affairs (making application /submission , tracking, follow up & responding to concerned Govt Authority ), all matters related to RA Principal Responsibilities
To ensure timely approvals / Import Licences /Other Licences any other certificate for products as per Imports Plan/Sales plan .
Timely preparations / submission of applications and follow up with concerned Govt Authorities ( ie DCGI office / or any other Ministry / Govt office .
To interact with various Departments within BD to take necessary feed back to meet above objective .
To prepare response and appear on behalf of the company for any presentation request issued by regulators and appear for Personal Hearing .
To maintain all records related to RA / filings.
Other work related to RA Deptt assigned time to time by Head -RA
Unique Skills & Knowledge
Knowledge of drugs & Cosmetics Act & Medical Device Rules
Computer Literate ( Words /Excel / PPT )
Influencing and Interpersonal skills
Drive for achieving results / Result Orientation
Conflicts Resolution & Problem Solving
Communication (both verbal and non verbal)
Knowledge of standards and work experience within BIS Contacts (Internal & External) Internal
Head -Regulatory Affairs
Associates from WW RA teams / Quality / Manufacturing sites
All BD – India Associates (on need basis)
All BD Associates at manufacturing locations world wide
Regulators / Govt Officials
Primary Work Location
IND Gurgaon - Signature Towers B
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.