Job title: Liaisoning Specialist – Regulatory Affairs
Company: Bayer
Job description: At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Liaisoning Specialist – Regulatory Affairs
YOUR TASKS AND RESPONSIBILITIES:
- 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
WHO YOU ARE:
- Bachelor’s degree in Science (B Sc/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
Bayer does not charge any fees whatsoever for recruitment process. Please do not entertain such demand for payment by any individuals / entities in connection with recruitment with any Bayer Group entity(ies) worldwide under any pretext.
Please don’t rely upon any unsolicited email from email addresses not ending with domain name “bayer.com” or job advertisements referring you to an email address that does not end with “bayer.com”. YOUR APPLICATION
Bayer is an equal opportunity employer that strongly values fairness and respect at work. We welcome applications from all individuals, regardless of race, religion, gender, age, physical characteristics, disability, sexual orientation etc. We are committed to treating all applicants fairly and avoiding discrimination.
Location: India : Delhi : Delhi
Division: Pharmaceuticals
Reference Code: 718183
Contact Us
+ 022-25311234
Expected salary:
Location: Delhi
Job date: Wed, 07 Sep 2022 02:59:28 GMT
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