Job Description

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Regulatory Professional

Category: Reg Affairs & Safety Pharmacovigilance

Location:

Bangalore, Karnataka, IN

Department: Research & Development

Do you want to play a key role in accelerating the development of our patient-focused products? Are you passionate about regulatory science and executing on regulatory strategies to bring innovative medicines to patients?

If so, we invite you to become a part of our dynamic and forward-looking regulatory organisation. We are expanding our team of highly engaged professionals who play pivotal roles in developing medical solutions and obtaining approvals from regulatory authorities worldwide.

Apply now and join us in this exciting journey!

Position

As a Regulatory Professional 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 diabetes portfolio.

Your key responsibilities will be focused on:

• Become a member of cross functional project teams including study groups and submission teams and provide regulatory input within the Semaglutide department.
• Drive, coordinate and actively follow-up on several tasks with challenging and often overlapping timelines.
• Participate in the development of regulatory documentation for submission to Health Authorities, including briefing packages for meetings with Health Authorities, clinical trial applications, clinical trial protocols and reports 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 and non-medical specialists, statisticians, and medical writers.

Furthermore, you will work in a fast-paced environment with tight deadlines and deal with the challenging reality of international communication across time zones, cultures, and circumstances. The atmosphere is informal and good humor is always welcome.

Qualifications

• 5-8 years of experience in related field along with Graduate Degree is required.
• International Work experience or previous experience with working in a global setting.
• Experience in handling health authorities/government bodies/local market authorities is must.
• Experience in handling life cycle management of product is required.
• Experience in handling different global and national regulatory submissions is required. Experience in handling clinical trial applications is an advantage.
• Global exposure in terms of handling different markets.
• Excellent communication and presentation skills.
• Ability to cross collaborate and work with the teams and stakeholders from different backgrounds and culture in a Hybrid setup.

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 NN 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 value chain on core regulatory processes across 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

At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.

Contact

If you believe you are a match for the above requirements and are highly motivated to take up the role, please apply here with our online application tool.

Deadline

Apply on or before: 15th March 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.

Novo Nordisk