Novo Nordisk Regulatory Professional I openings in Bangalore for Post-Graduation or comparable degree in science candidates. Novo Nordisk is a global healthcare company that is committed to improving the lives of people with diabetes and other chronic diseases. The company has a strong focus on research and development, and has a number of research and development centers located around the world. If you are interested in working in regulatory affairs at Novo Nordisk check below.
The Position As a Regulatory Professional IORA OCE (Operational Centre of Excellence), an ideal candidate will be responsible for securing the regulatory approvals for NN products in due time for countries in the allocated region. The responsibilities further include managing the new drug application, product’s life cycle management & will support approval & post-approval activities such as timely submission of the application as per country-specific HA (health authorities) requirements, reviewing the content of submission package, identifying the necessary documentation for submissions, and preparing the local documents as required by local Health Authority. Reviewing the list of documents required for tender, or any other submissions will be an important aspect of this role.
The professional will be responsible for ensuring RA system update (Veeva Vault) with product dossier & approval information within the agreed timelines. In collaboration with colleagues at affiliates, supporting the development of labeling materials, reviewing, and approving promotional materials, and re-packaging specimens according to the local legislation and standard operating procedures is also a key responsibility of this job role. In addition to the above, supporting colleagues in affiliates & working very closely with 3rd party distributors in monitoring the local regulatory environment and ensuring overall regulatory compliance is expected. This position requires one to be highly self-motivated, proactive and organized and have excellent stakeholder management & communication skills. We are looking for candidates who have ability to articulate regulatory signals and a good understanding of country-specific HA requirements.
- Post-Graduation or comparable degree in science.
- Above 5 years of experience in the pharmaceutical industry in Regulatory Affairs.
- 3+ years working with key stakeholders and decision-makers outside India in a cross-functional, international environment.
- Experience working in an Affiliate environment & shared service model preferred
- Good understanding of E2E regulatory processes. Hands-on experience in handling conversations with the Indian Health authority is preferred.
- Hands-on experience in compilation of registration/re-registration dossier in national / eCTD / NeeS / ACTD & standard format. Good understanding of Veeva Vault RA systems
- Highly proactive and able to take initiative & manage multiple priorities. Self-managed, strong personal drive 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
- Basic project management & excellent written/spoken communication skills
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 to manufacturing, marketing and sales- we’re all working to move the needle on patient care.ContactIf 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.
DeadlineApply on or before: 17th January 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 committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in. Together, we’re life-changing