Regulatory Professional I

3 weeks ago

Bengaluru, India Novo Nordisk Full time

Regulatory Professional I

**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: Global Regulatory Affairs**Position**- 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**
- 6-8 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**Deadline**
- **24 November 2023**
- 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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