Novo Nordisk Job vacancy for Global Regulatory Affairs
Bengaluru, Karnataka, India On-site
Department: Global Regulatory Affairs
Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as “Regulatory Affairs Specialist” with us. “Apply now” – At Novo Nordisk, we assure you will experience the best.
About The Department
Regulatory Affairs play an important role in ensuring that all new Novo Nordisk treatments and devices are developed with compliance and the patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs are involved throughout all phases of product development and roll-out. Our people in Regulatory Affairs come from many different academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure minimum time to market. This makes Regulatory Affairs a truly multi-disciplinary place to work with high professional standards, excellent opportunities for fast-paced professional development and career opportunities.
The Position
As a Regulatory Affairs Specialist, responsibilities include planning, preparing, and submitting high quality files to the health authorities achieving fast approvals. You will work as an integrated part of global cross-functional teams with stakeholders ranging from safety, medical affairs, commercial to our Novo Nordisk affiliates worldwide. An ideal candidate will be further responsible for preparation and delivery of meeting packages to Health Authorities, conducting Health Authority interactions, and regulatory approvals globally. Demonstrating subject matter expertise within regulatory science including but not limited to profound knowledge about regulatory processes and activities related to global Life Cycle Management activities is expected.
- Compile, review and submit pre-meeting packages for authority meetings.
- Handle post approvals, query response, change requests from QA.
- Submission of regulatory files, response to health authorities and maintenance of marketing authorizations worldwide.
- Pharmacovigilance documentation like Drug Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), Investigation Brochures, Clinical Trial Reporting and clinical trial applications.
- Handle Life Cycle Management (LCM) of the product, keeping the product live- clinical file protocols and Interim study reports.
Qualifications
- 10+ years of experience in Regulatory affairs (within CMC/NDA/Clinicals) related field along with Graduate or Post graduate degree is required.
- Experience in handling health authorities/government bodies/local market authorities is must.
- Experience in handling life cycle management of product is required.
- Global exposure in terms of handling different markets.
- Excellent communication and presentation skills.
- Bold and strong personality with proven negotiation skills (Should be able to convince and put forward the facts confidently)
- Self-managed, strong personal drive, team player and ability to engage with colleagues and peers towards delivering excellent performance and results.
- High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones.
Working At Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales- we’re all working to move the needle on patient care.
Contact If you believe you are a match for the above requirements and are willing to take up the role, please apply here with our online application tool.
Deadline Apply on or before: 16th June, 2023
