Summary
Date Posted: Friday, August 26, 2022 , Base Salary: Not Disclosed

JOB DETAILS:
Regulatory Affairs Manager
Are you motivated by creating visible results? Are you enthusiastic about understanding the business and the people and driving innovation for the life-changing benefit of patients? Then, this is your moment to take the next step in your professional development in a globally expanding company. Join Novo Nordisk as Regulatory Affairs Manager, Middle Africa and get a life-changing career!
This role is based in Nairobi, Kenya and directly reports to the Head, Medical, Regulatory & Quality (MRQ), Middle Africa.
The Position
As the Regulatory Affairs Manager, you will be responsible for developing Middle Africa affiliate level regulatory strategy and implementation plans, leading the RA team in coordinating and supervising product Life Cycle Management (LCM), New Drug Applications (NDA), safety submissions and other regulatory applications, label creation, and stakeholder management in providing regulatory support and insight to key stakeholders. In addition:
• Regulatory Affairs budget management
• Leadership and setting direction and guidance to the regulatory team, distribution of tasks, roles, and responsibilities, end to end performance management and team development
• Ensure compliance with internal SOPs and external requirements within the Regulatory Affairs department in collaboration with affiliate PV, Quality and commercial teams, and Business Area and Global Regulatory teams.
• Stakeholder management and collaboration with local, regional, and global regulatory, marketing, medical, supply chain, QA/QC, and health authorities to deliver on regulatory commitments and documentation required by the other functions.
• Regulatory department audit readiness, surveillance of regulatory intelligence as well as participation in key external regulatory networks

Qualifications
• Relevant academic degree, preferably in Pharmacy or Medical Sciences.
• Minimum of 5 years of working experience in the Pharmaceutical Industry preferably in Regulatory Affairs in a multinational company.
• Knowledge of pharmaceutical legislation within Middle Africa.
• Excellent command of both written and spoken English and have a relevant business background.
• Strong stakeholder engagement, communication, and presentation skills can provide recommendations despite uncertainty and pressure and are able to handle and simplify complexity while focusing on the bigger picture.
• Team player attitude, but at the same time possess independent drive, and have a can-do mindset.
• Proven success in strong leadership and interpersonal skills and a structured and transparent way of working

Work Hours: 8

Experience in Months: 60

Level of Education: Bachelor Degree

Job application procedure
Interested and qualified? Go to Novo Nordisk on careers.novonordisk.com to apply

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