Job Description

Department: Global Regulatory Affairs

Join Regulatory Affairs (RA) and become part of an exciting environment where engaged people are committed to ensure the life cycle management of Novo Nordisk's medicines by regulatory authorities across the globe. Regulatory Affairs is a fast-changing field where no two days are alike, and the engaged employees in our unit need a unique combination of scientific insight and the ability to navigate tight deadlines and many stakeholders. Apply now and join a growing team, working in an international environment.

Position

As a Senior Regulatory Professional, you are expected to demonstrate leadership by setting the regulatory strategy and being responsible for 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. As part of our department, you will be responsible for planning and driving regulatory activities and deliverables according to agreed timelines and quality. You will be accountable for specific deliverables such as submission and approval of clinical trial applications, driving and coordinating preparation of meeting packages to Health Authorities, conducting Health Authority interactions, and regulatory approvals globally. You must demonstrate 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. Furthermore, in the role you will also handle: -

• Compile, review and submit pre-meeting packages for authority meetings.
• Handle change requests
• 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), Risk Management Plan (RMP), renewals, post approval changes.
• Handle Life Cycle Management (LCM) of the product, keeping the product live- clinical file protocols and Interim study reports.

Qualifications

• 9-12 years of experience in related field along with Post Graduate Degree is required.
• International Work experience or previous experience with working in a global setting. Qualifications. (from recognised platform will be an add on).
• 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 Clinical regulatory submissions is required.
• Global exposure in terms of handling different markets.
• Team/people management experience is an add-on.
• 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

We are a proud life-science company, and life is our reason to exist. We're inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the basis of ground-breaking scientific research, to our rich personal lives that motivate and energise us to perform our best at work. Ultimately, life is why we're all here - to ensure that people can lead a life independent of chronic disease.

Contact

To submit your application, please upload your CV and motivational letter online (click on Apply and follow the instructions).

Apply now!

Deadline

10th Nov 2022

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.