Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen.
Post : Liaisoning Specialist - Regulatory Affairs
Job Description
• Act as the one-point contact for DCGI/ FDA and other govt bodies
• Receiving the documents for DCGI/FDA/Govt Bodies submission and doing the submission
• Keeping a track on the applications and the query response submitted to the DCGI /FDA /Govt Bodies
• Giving an heads up of any anticipated questions /feedback from DCGI/FDA/Govt bodies
• Facilitating meetings and cooperation among people, agencies and Bayer colleagues during the visit to these govt institutions
• Keeping a track on the new regulations and giving an update on the same
• identifying issues in communication and coordination within the company or organization and creating solutions for overcoming these challenges
• Prepare documents to support licensing activities (eg. submissions, testing and import licenses, tenders, safety reporting, post-approval commitments) to India health authority and other government institutions
• Support process improvements and implementation of best practices within RA India
• Database maintenance: timely and accurate maintenance and updating of tracking sheets, contact reports, regulatory information as defined by RA India KPI
• Support for follow-up in CDL/IPC/NIBL and other govt lab
Candidate Profile
• Bachelor’s degree in Science (BSc / MSc) / Pharmacy / Pharmaceutical Sciences or other Life Sciences / technical subjects or related discipline with 1-2 years of regulatory affairs experience in pharmaceutical industry
• Have experience liasioning with the Govt bodies /Institutions
• Ability to work independently and with diverse stakeholders
• Have basic communication skills both oral and written to interact with stakeholders based in various locations and diverse local stakeholders
• Ability to multi-task and work to competing, tight deadlines. Ability to prioritize workload to deliver on pre-agreed KPIs
• Computer literacy with MS Office. SharePoint highly desired. Willingness to learn new systems and processes as required
• Motivated self-starter with good interpersonal, organization, and problem-solving skills
Additional Information
Qualification : B.Sc, MSc, B.Pharm
Location : Delhi
Industry Type : Pharma
Functional Area : Regulatory Affairs
End Date : 30th September, 2022
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