Regulatory Professional I

3 weeks ago

Bengaluru, India Novo Nordisk Full time

   

Department: RA Submission Systems Development

 

Are you passionate about ensuring compliance and streamlining regulatory processes in the dynamic field of life sciences? Do you have a passion for regulatory affairs and a desire to shape the future of the industry?

We are looking for a Regulatory Process Expert to join the team implementing centralised translations in Regulatory Affairs at Novo Nordisk. Be part of our life-changing careers and apply today

 

The Position

As a Regulatory Process Expert for translations, you will be responsible for a variety of tasks and responsibilities including:

  • Be responsible for defining a standardized Regulatory Affairs translation process, including roles and responsibilities, and defining which Regulatory documents are in scope.

  • Gather business requirements from relevant stakeholders and future users in Regulatory Affairs HQ and affiliates.

  • Ensure ongoing alignment with relevant stakeholders to maintain process robustness and compliance, and with vendors to meet all NN requirements and escalate issues as necessary.

  • Translate process requirements into requirement specifications for GlobalLink, the centralized translations system, and assist with IT systems integration tests and validation as needed.

  • Prepare Central Translations end-user guides, communication, and training material and Collect end-user feedback for ongoing process optimisation.

  • Oversee the Language Lead network, providing support to Central Translations Coordinators and end-users, while also assisting the Central Translations team during internal audits and inspections of both process and IT applications.

  • Be accountable for updating SOPs and ensuring alignment with affiliates regarding local SOP updates as necessary, while also creating and managing Change Requests and deviations.

 

Qualifications

To be successful in this role, you should have at least:

  • Proven experience (ideally 5+ years) working in Regulatory Affairs.

  • High level understanding of regulatory translation needs.

  • Recent track record of working with submissions and translations.

  • Preferably experience with working in Vault RIM or other Veeva Vaults.

  • Excellent stakeholder management skills and relation building skills.

  • Very good team cooperation and communication skills.

  • Be able to identify risks and find mitigating solutions.

 

About The Department

Regulatory Affairs is an exciting area involved across the full value chain. We are responsible for global regulatory strategies to obtain and maintain regulatory licenses for current and future products, responsive to the worldwide business needs of Novo Nordisk.You will become part of RA Submission Systems Development. The department has Regulatory Process Experts and Business Administrators in Denmark and India who work with Vault RIM and GlobalLink in various cross-functional teams. We support a flexible workplace, with a mix of in-office and remote work. This position is based in India and you will have the chance to join the cross-functional project team that works on implementing the centralised translations process in Regulatory Affairs.

 

Working at Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world, and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we’re working toward something bigger than ourselves, and it’s a collective effort. Join us Together, we go further. Together, we’re life-changing.

 

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: 17th  May 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.

 

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