Regulatory Professional I

Position: Regulatory Professional– RA Submissions

Categorise in headlines the key responsibilities that demonstrates the variety of roles that the organisation expects the position to fulfill

Key Responsibilities:

Responsible for compiling and publishing the submission of Marketing Authorisation application (MAA)/Life cycle Management application to European Health Authorities

Responsible for regulatory global publishing (electronic) as per CTD/eCTD/NeeS/National format

Responsible for maintenance and user support of regulatory systems and processes within area of responsibility

Handling jobs independently

Responsible for trouble shooting in publishing

Main Job Tasks:

Support and facilitate regulatory publishing in electronic format as per regulatory requirement

To use and optimise existing systems of regulatory publishing for timely submissions

Responsible for New Drug Application / Marketing Authorisation Application publishing

Implementation of Extended publishing support or National submission Ensure process implementation/improvement with in Publishing Support GSC, as per the Extended Publishing support need

Acts as liaison with individuals and groups to facilitate publishing need

Tracks the progress of project, identifies issues & provides inputs to RA Project Manager & Line of Business Manager

Coordinates with working groups (Publisher) for process implementation of tasks in more detail - ensure to list compliance/quality related tasks/responsibilities

Qualifications

Education:

· Life science Graduate

Experience:

· Above 6 years of experience in Pharmaceutical Industry in Regulatory Affairs

· Exposure to EU submissions is must

· Experience of compilation of dossier in eCTD, NeeS & Standard format.

· Experience in Regulatory IT system like VAULT, Lorenz etc.

· Experience in Document Management system

· Experience in Veeva Vault

Mandatory Requirements:

· Knowledge in MS-Office

· Good Communication Skills

· Good subject knowledge in academics

· Active in self development

· Readiness to changes

· Is service minded and customer oriented

· Demonstrates a high quality mindset

· Ability to work in teams

· Active involvement in Business process

· Readiness for handling other tasks

· Reaches agreements through flexibility

· Takes initiative to improve procedures that are not providing value to the business

· Think ahead and identify challenges, work independently, proactively and efficiently

· Strong attention to detail.

Working at Novo Nordisk

At Novo Nordisk, we have been changing diabetes since 1923. If you are ready to strengthen our position as an innovative pioneer and respected industry leader, we encourage you to join us to make the most of your talent. In exchange, we offer you the opportunity to work with extraordinary talent globally and benefit from a range of possibilities for professional and personal development.

Deadline

20 May 2021.

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.