Novo Nordisk Associate Regulatory Professional Vacancy – Apply Online
Novo Nordisk Associate Regulatory Novo Nordisk Pharma Job – Pharma Apply Online. Postgraduate and undergraduate pharma candidates apply. candidates are eligible to apply online for an Associate Regulatory Professional post. Associate Regulatory Professional position. Check out all the details on Rasayanika.com
Job Title: Associate Regulatory Professional II
The position
As an Associate Regulatory Professional II, you will be responsible for driving operation compilation & delivery of country-specific renewals, manufacturing site registration, NDA submissions.
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 by coordinating with various internal & external stakeholders involved.
Furthermore, for the submission with publishing requirements, 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 Q&A from Health Authority within the timeline as required.In addition to the above, you will support our colleagues in affiliates from across IO regions [LATAM, APAC & SEMEEA] in monitoring the local regulatory environment, ensure overall regulatory compliance and ensure timely submissions with high quality.
This position requires you to be highly self-motivated, proactive, organized, and have excellent stakeholder management & communication skills. We are looking for candidates who have a high ability to articulate regulatory signals and a good understanding of local HA requirements.
Qualifications
Below are the required skills.
- Post-Graduation or comparable degree in Science/Pharma/Regulatory Affairs/Quality
- Above 2 years of experience in the pharmaceutical industry in Regulatory Affairs
- Basic knowledge on Pharmaceutical Regulatory overview
Experience in Regulatory Submission compilation formats & requirements - Good understanding on Regulatory guidelines
- Good knowledge on 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
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