Job Description

By continuing to use and navigate this website, you are agreeing to the use of cookies.
Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading...CategorySelect how often (in days) to receive an alert:xc3x97Select how often (in days) to receive an alert:Regulatory Affairs Portfolio ManagerCategory: Reg Affairs & Safety PharmacovigilanceLocation:Johannesburg, Gauteng, ZAAre 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 PositionAs 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

QualificationsAs 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 DepartmentThe Regulatory Affairs department in Johannesburg, South Africa is a dynamic and fast-paced team that is dedicated to ensuring regulatory compliance and driving changes andimprovements. 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.Working at Novo NordiskAt Novo Nordisk, we don't wait for change. We drive it. We're a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales - we're all working to move the needle on patient care.ContactPlease click on "apply now" to submit your resume in English.DeadlineApply before 14 JuneWe 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.

Novo Nordisk