Affiliate Regulatory Affairs Portfolio Manager at Novo Nordisk

The Position

• Responsible for compiling, submission and approval activities for New Drug Application (NDA), renewals, and Life Cycle Management (LCM) licences under supervision of RA Manager. Monitor local regulatory environment and ensure compliance. Develop local labelling and ensuring the regulatory compliance in promotional material.

The position holder will also provide support to the local RA Manager in training RA employees.

Your key responsibilities include:

• Monitor local regulatory environment and ensure regulatory compliance; interact constantly with Health Authorities (HAs) to ensure timely approvals, detect regulatory trends and keep up-to-date with legislation at affiliate.
• Responsible for compiling, submission and approval of NDA and LCM licences; manage the compilation and preparation of regulatory documents, information, data technical files to support approvals for new product registration, renewals and changes (NDA and LCM licenses):
• Support in developing labelling materials and review/approve promotional materials; review the promotional materials to ensure overall legal compliance with HA’s requirements.
• Provide regulatory support and insight to key stakeholders; provide advice and recommendations to local RA Manager at local level on regulatory policy and applicable strategy in order to accelerate regulatory approvals while securing compliance.
• Internally, collaborate with other departments in the affiliate (Marketing, Legal, Logistics, Sales) providing them with information of regulatory matters when necessary.

Qualifications

To be successful in this role, you need to have University degree, preferably related to pharmaceutical studies/ Bachelor’s Pharmacist degree.

To be effective in this role, we expect you to have:

• Minimum 1 year experience in the Regulatory as an RA Associate
• Knowledge of local legislation
• Stakeholder management skills
• Business & Industry Insight knowledge