Do you want a chance to really make a difference? Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference. Check out all the details on the same below:
Job Title: Associate Regulatory Professional for Regulatory
Location Bangalore, India
Qualifications
- Post-Graduation or comparable degree in Science/Pharma/Regulatory Affairs/Quality
- 2+ years of experience in the pharmaceutical industry in Regulatory Affairs
- Basic knowledge on Pharmaceutical Regulatory overview
- Experience in Regulatory Submission compilation formats & requirements
- Extensive working experience in the Veeva Vault system is mandatory
- Good understanding of Regulatory guidelines
- Good knowledge of Regulatory IT systems & tools.
- Basic project management skills
- Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results
- Highly cultural sensitive and comfortable working with different countries and cultures across multiple time-zones
The position
- As an Associate Regulatory Professional, you will be responsible for dossier compilation of renewals & manufacturing site registrations as per the country-specific requirements. And delivery of country-specific renewals, manufacturing site registration.
- You will be working on preparing a submission operational plan for the upcoming renewals and manufacturing sites submissions based on Regulatory Information Management System (RIMS) & site registration due dates for renewals or based on T- Tool extract for manufacturing sites. Additionally, you will be responsible for creating, manual matching & baselining the submission content plan in Veeva vault RIM (compilation of dossiers in national / eCTD / NeeS & standard format), and support in the delivery of required documents.
- Furthermore, for the submission with publishing requirement, you will ensure to raise publishing online form requests according to submission size and publishing lead times.
- You will be responsible for ensuring RA system update with approval information within the agreed timelines and handling Question & Answer from Health Authority within the timeline as required.
- In addition to the above, you will closely interact with various internal and external stakeholders involved & support affiliates from across International Operations (IO) regions [LATAM, APAC & SEMEEA] in supporting successful submissions to National Authorities and reduced lead times and time to market.
- This position requires you to be highly self-motivated, proactive, organized, and have excellent stakeholder management & communication skills. In addition, you thrive in an environment with changing circumstances and bring a can-do attitude. You bring an innovative & continuous improvement mindset to drive the business.
Editors Note: Novo Nordisk Regulatory Associate Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
