Regulatory Affairs Portfolio Manager

4 weeks ago

Johannesburg, South Africa Novo Nordisk AS Full time

Are you passionate about driving changes and improvements? Do you want to be a part of a fast-growing and developing company that is dedicated to helping people? If so, we have an exciting opportunity for you to join Novo Nordisk as a Regulatory Affairs Portfolio Manager. Apply today and join us for a life-changing career

This position will be based in Johannesburg, South Africa under the Regulatory Affairs department. You will directly report to the Head of Regulatory Affairs & Pharmacovigilance Novo Nordisk.

The Position

As a Regulatory Affairs (RA) Portfolio Manager, you will be responsible for compiling, submission, and approval activities for New Drug Application (NDA), Renewals, Medical Devices, and Life Cycle Management (LCM) licenses under the supervision of the RA Manager. In addition, you will be monitoring the local regulatory environment and ensuring compliance.

Your main accountabilities will be:

• 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 the affiliate

• Responsible for compiling, submission, and approval of NDA and LCM licenses; manage the compilation and preparation of regulatory documents, information, data technical files to support approvals for new product registration, renewals, section 36, once-off batch applications, and maintain license to operate

• 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 the local RA Manager at the local level on regulatory policy and applicable strategy to accelerate regulatory approvals while securing compliance

• Internally, collaborate with other departments in the affiliate (Marketing, Legal, Logistics, Sales) providing them with information on regulatory matters when necessary

Qualifications

As a Regulatory Affairs Portfolio Manager, you need to have a University degree, i.e., a Bachelor of Pharmacy degree. Moreover, you need to have a minimum of 5 years of experience in Regulatory Affairs.

To be successful in this role, you should have:

• Knowledge of local legislation

• Stakeholder management skills

• Business & Industry Insight knowledge

• We would expect you to have the ability to make things happen, with a proactive and team player attitude.

About the Department

The Regulatory Affairs department in Johannesburg, South Africa is a dynamic and fast-paced team that is dedicated to ensuring regulatory compliance and driving changes and

improvements. As a member of this team, you will have the opportunity to work closely with Health Authorities, develop local labelling materials, and provide regulatory support and insight to key stakeholders. Join us and be a part of our mission to make a difference in the lives of millions of patients.

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