The responsibilities will also include

• Training and communicating the QMS throughout the local affiliate organization, and distributing Quality Docs (SOP) updates to affiliate employees and maintenance of Quality Docs List
• Tracking of local quality laws and requirements in the affiliate also assisting review of the list of NN Procedures, QA approval, uploading local procedures in Quality Docs (SOPs), making reviews and updates of local procedures in Quality Docs as applicable. Distributes Quality Docs (SOP) updates to affiliate employees and maintenance of Quality Docs (SOP) List.
• Act as the Local GxP records Manager in maintaining status for documents in Archiving system for the affiliate. Serve as the affiliate Change Request and Deviations Expert on NovoGlow, and be responsible for preparation of QMR input and minutes of meeting with identified action points.
• Serve as lead auditor responsible for local distributor audits. Track the local quality laws and external requirements in countries. Ensure the distribution of the updated procedures (SOPs) to distributors before effective date

Qualifications

• You hold a bachelor’s degree in Pharmacy, pharmaceutical related studies, or medical sciences with a minimum of 3-5 years working experience in the similar position. A Master’s degree is a plus. You have excellent command over both written and spoken English. Further sought-after skills are:
• You have an innovative mindset
• You are good at computer and IT skills
• You have a strategic mindset, and great planning and execution skills.
• You have strong communication skill and an ability to build and maintain strong working relationships with various stakeholders.
• You are driven, can take initiative, and are agile in actions and detail oriented

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The Other Responsibilities Will Include.

• Providing training in pharmacovigilance requirements in Middle Africa and ensuring that all personnel in Middle Africa involved in pharmacovigilance activities should be aware of the principles of pharmacovigilance that affect them, and all personnel shall receive relevant PV training. Ensuring that a backup person(s) is appointed to carry out PV activities their duties during the absence of the QPPV
• Establishing and maintaining a system which ensures that information about all suspected adverse drug reactions/events (or spontaneous post-marketing events) which are reported to NN personnel are collected, collated and sent to GS for processing within the timelines
• Having oversight of the pharmacovigilance system in Middle Africa countries including quality management system. And preparing, reviewing, and implementing company SOPs for PV activities in Middle Africa countries
• Establishing and maintaining a system which ensures that information about all suspected adverse drug reactions/events (or spontaneous post-marketing events) which are reported to NN personnel is collected, collated and sent to GS for processing within the timelines. And submitting the relevant documents prepared by Global Safety in HQ to the Health authority in Kenya through established channels after evaluation as applicable and within applicable timelines:
• Collaborating with internal stakeholders, Logistic, Marketing, Legal, Sales, BA, etc. to coordinate PV activities and help the Manager to set up annual strategy for the region in respective area. And acting as a point of contact to the Health Authority on all matters relating to the product safety and quality of marketed products in Kenya including pharmacovigilance inspections.

Qualifications

• You hold a bachelor’s degree in Pharmacy, pharmaceutical related studies, or biomedical sciences with a minimum of 5 years working experience in the similar position. A Master’s degree in PV, Patient Safety, Health systems management is a plus. You have excellent command over both written and spoken English. Further sought-after skills are:
• You have an innovative mindset as the position requires very fast adaptation to changes and innovations in the industry.
• You have a strategic mindset, and great planning and execution skills.
• You also have people management experience and a team-oriented personality and can lead without authority, share knowledge, and coach team members.
• You are good at computer and IT skills and a working knowledge of systems
• You are driven, can take initiative, and are agile in actions and detail oriented

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The Job

As a Regulatory Affairs Specialist, you will be responsible for coordinating and supervising Regulatory Affairs applications related to Product Life Cycle Management (LCM) and/or New Drug Approvals (NDA) in West and Central Africa and provide support as required for Middle Africa. Develop, review and update labelling and ensure RA compliance in promotional material according to local legislation and Standard Operation Procedures (SOPs).

• Monitor the regulatory environment and ensure compliance. Interact constantly with Health Authorities (HAs) to ensure timely submissions, track approvals, detect regulatory trends, and keep up to date with legislation at the affiliate. Maintain close interaction with local external stakeholders through an active presence in pharmaceutical associations and similar forums.
• Coordinate and supervise Regulatory Affairs applications related to NDA and LCM. Assess registration files, ensuring compliance of file content to regulatory requirements. Handle HAs or agents’ requests and demands on quality, clinical and non-clinical information according to NNAS standards/SOPs.
• Provide regulatory support and insight to key stakeholders. Contribute to shaping Novo Nordisk’s position on local HA proposals and guidance to provide the company’s input on regulatory initiatives. Help Affiliate RA manager to disseminate intelligence to relevant groups within Regulatory Affairs/CMR and other functions at a local level.
• 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. Ensure inspection and audit readiness for the RA unit in terms of archiving and documentation in place

Qualifications

You have a relevant academic degree, preferably in bachelor’s degree in Pharmacy or other related Pharmaceutical Sciences / biomedical sciences with a minimum of 5 years working experience as a Regulatory Affairs Specialist in a multinational company covering West and Central Africa. A Master’s degree in Pharmacy / Biomedical Sciences / Business Administration is a plus.

To Qualify For The Position, You Must Have

• Knowledge of pertinent local regulatory affairs legislation in West and Central Africa
• Experience with regulatory intelligence activities and pharmaceutical registration databases.
• An innovating in a changing environment mindset as the position requires very fast adaptation to changes and innovations in the industry.
• and analytical skills and be capable of working in a culture of respect, teamwork, and personal responsibility.
• Fluency in written and spoken English is required.

About The Department

The Novo Nordisk Middle Africa Affiliate consists of 49 countries and was formed early in 2012. Novo Nordisk has a well-established presence in Africa with the best quality human insulin and our focus today is to sustain the growth of the market, ensure access to better quality modern insulin and newer product formulations and support people living with diabetes.

Working at Novo Nordisk

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 the communities we operate in.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.