Regulatory Affairs Specialist at Novo Nordisk

Novo Nordisk is looking for a motivated and well-rounded person to take up the role of Regulatory Affairs Specialist for Middle Africa (MA) on a Contract basis renewable annually based on performance. This person will support the implementation of the Regulatory Affairs strategy and drive Regulatory Affairs activities across Middle Africa in compliance with Novo Nordisk and local regulatory requirements and will be based in Nigeria.

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.

The Job

The Regulatory Affairs Specialist will be responsible for the following: Coordinating and supervising Regulatory Affairs applications related to New Drug Applications (NDA) and Life Cycle Management (LCM)

• Assessing registration files and ensuring compliance of file content to regulatory requirements.
• Handling HAs or agents’ requests and demands on quality, clinical and non-clinical information according to Novo Nordisk standards/SOPs.
• Ensuring timely submission and follow-up of labelling variations to the local HAs, in
• cooperation with the key stakeholders.
• Managing NDA submissions in accordance with local regulation ensuring the files are prepared and submitted in time.
• Maintaining license to operate in affiliate by timely management of renewals and LCM activities.
• Coordinating actions effectively and proactively with other functions to support product launches, LCM activities, and supply in due time.

Monitoring the regulatory environment and ensuring compliance:

• Monitoring the regulatory environment and ensuring full compliance with relevant legislation and with internal SOPs.
• Updating and implementing local regulatory procedures.
• Interacting constantly with Health Authorities (HAs) to ensure timely approvals, detecting regulatory trends, and keeping up-to-date with legislation at the affiliate.
• Maintaining close interaction with local external stakeholders through an active presence in pharmaceutical associations and similar forums.
• Proactively sharing regulatory intelligence with internal stakeholders on competitors’ products as well as on emerging regulations.

Provide regulatory support and insight to key stakeholders:

• Contributing to shaping Novo Nordisk’s position on local HA’ proposals and guidance in order to provide the company’s input on regulatory initiatives.
• Helping Affiliate RA manager to disseminate intelligence to relevant groups within Regulatory Affairs and other functions at a local level.
• Maintaining fluent interaction with pharmaceutical associations and key regulators in order to reinforce Novo Nordisk’s presence locally.
• Providing advice and recommendations to local RA Manager at the local level on regulatory policy and applicable strategy in order to accelerate regulatory approvals while securing compliance.
• Ensuring inspection and audit readiness for 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 with a minimum of 3 years of working experience and a Minimum 1-year experience in Regulatory Affairs as a Regulatory Affairs Associate experience in a multinational company.
To qualify for the position you must have:

• Knowledge of pertinent local legislation.
• 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.