Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy.
Post : Regulatory Professional I
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.
Job Description
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.
Candidate Profile
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.
Additional Information
Experience : 5+ years
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : RA Submission Systems Development
End Date : 17th May 2024
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