BD (Becton, Dickinson and Company) Executive Regulatory Affairs in Gurgaon, India

Job Description Summary

Job Description

Position Title

Executive - Regulatory Affairs

Department

Regulatory Affairs

Location

Gurgaon

Reports to

Director – GA & RA

Qualification

Graduate in Microbiology / Biochemistry / Pharmacy

Experience

3 + Years experience in handling RA ( Preferably IVD industry )

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 / Registration Certificates / 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 in BD to take necessary feed back to meet above objective .

  • To prepare response and appear on behalf of the company for any SCN 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

  • Computer Literate ( Words /Excel / PPT )

  • BD Values

  • Product understanding

  • Customer Focus

  • Influencing and Interpersonal skills

  • Drive for achieving results / Result Orientation

  • Conflicts Resolution & Problem Solving

  • Communication (both verbal and non verbal)

  • Continuous Learning

Contacts (Internal & External)

Internal

  • Head -Regulatory Affairs

  • Associates from WW PAS / BDD Business / Quality / Manufacturing sites

  • All BD – India Associates (on need basis)

  • All BD Associates at manufacturing locations world wide

External

  • Regulators / Govt Officials

  • Consultants

Critical Challenges

To deal with Government bodies with full compliance of BD values / Ethics

Problem Solving & Decision Making

Should be good on this.

Primary Work Location

IND Gurgaon - Signature Towers B

Additional Locations

Work Shift

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.