Regulatory Professional I

1 week ago

Bengaluru, India Novo Nordisk Full time

   

Department: RA Semaglutide and GLP-1, Global Regulatory Affairs

 

Are you passionate about ensuring regulatory compliance for new products and product amendments? Do you thrive in a fast-paced and challenging environment? We are looking for a Regulatory Professional I to join our Global Regulatory Affairs team in Novo Nordisk. If you are ready for a life-changing career, read on and apply today

If you are detail-oriented, have strong communication skills, and are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity.

The position

As a Regulatory Professional I, you would collaborate closely with the Global Regulatory Lead and a team of regulatory professionals, working together to advance projects across all development phases within the Semaglutide portfolio.

As a Regulatory Professional I at Novo Nordisk, you will have the opportunity to:

  • Support and provide input to all regulatory submissions to Health Authorities worldwide.

  • Become a member of cross-functional project teams and provide regulatory input within the Semaglutide department.

  • Drive, coordinate, and actively follow-up on several tasks with challenging and often overlapping timelines.

  • Prepare and submit documents/dossiers pertaining to the life cycle management of marketed products, such as DSUR, PSUR, safety signal management, risk management plan (RMP) updates, Investigational Brochure (IB) review and updates, and more.

  • Participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings, clinical trial applications, and regulatory files for marketing authorization, working with affiliates to ensure alignment between local and global regulatory strategies and timely preparation of documentation.

  • Interact with stakeholders across various departments, such as project management, medical/safety specialists, statisticians, and medical writers.

  • Establish and maintain core labeling, providing input for the development of text for core labeling and supporting labeling development throughout the product lifecycle.

Qualifications

To be successful in this role, we are looking for candidates with the following qualifications:

  • Preferred Master of Science (life sciences) relevant experience and/or PhD with 7+ years of relevant regulatory experience

  • Strong understanding of regulatory science and requirements in various regions including EU, US, China, Japan, and others.

  • Experience in life cycle management, label development, EU clinical trial applications, and health authority interactions.

  • Proficiency in regulatory intelligence.

  • Excellent communication and presentation skills.

  • Demonstrated project management skills.

  • Understanding of business management and the R&D value chain in the pharmaceutical industry.

  • Familiarity with digital health, competitive intelligence, disease understanding, statistics, pharmacovigilance, non-clinical and clinical pharmacology.

  • Knowledge of patient access and real-world evidence.

 

About the department

Global Regulatory Affairs (GRA) in Global Business Services (GBS) Bangalore is a global RA hub consisting of highly engaged regulatory professionals. We are contributing with core RA competencies enabling Novo Nordisk to secure fast, high-quality product approvals and life cycle management of our products. The team delivers strategic as well as operational support on a global scale across the value chain on core regulatory processes across the NN product portfolio. We collaborate very closely with our colleagues in RAHQ, Denmark (DK) as well as all our colleagues in the affiliates all over the world. That makes Regulatory Affairs truly interesting and challenging place to work.

 

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us Together, we go further. Together, we’re life-changing.

 

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: 28th June 2024.

 

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

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