Head of Regulatory Affairs

  • Nom de l'entrprise ALDAPH
  • Secteur d'activité Industries
  • Lieu de travail Alger, Algérie
  • Date d'expiration 30 Septembre
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Confirmé / Expérimenté
  • Niveau d'étude (diplome) Master 2, Ingéniorat, Bac + 5

Join Regulatory Affairs and become part of a fast-changing environment where engaged people do their best every day to get Novo Nordisk’s medicines approved across the globe. Our people have a unique combination of scientific insight, patient focus and the ability to navigate many agendas and stakeholders. That makes Regulatory Affairs a truly interesting and challenging place to work.
We are currently looking for a Head of Regulatory Affairs to join our Regulatory Affairs department.

 

Novo Nordisk Algeria belongs to International Operations, Region Asia Africa Middle East Oceania (AAMEO), and is one of the largest and most dynamic affiliated worldwide.

 

About the department:

  • The Regulatory Affairs department is part of the Clinical, Medical and Regulatory organization.
  • We are a dedicated team who are responsible for all the regulatory New Drug Applications, life cycle management, activities with clinical operations, Pharmacovigilance.
  • Role is critical to the success of an affiliate increasingly strategic for Novo Nordisk. You will report directly to the Clinical, Medical & Regulatory Director.
  • As Head of Regulatory Affairs, you will manage a team of regulatory affairs specialist and will be responsible to implement and follow the regulatory strategy.
  • You will manage a Regulatory Affairs applications related to product Life Cycle Management (LCM) and/or New Drug Approvals (NDA).
  •  You will be responsible for preparing, compiling and submitting documentation to Health Authorities and ensuring approvals.
  • You will work in a fast paced environment with tight deadlines and you will be supported by friendly team.

 

Qualification:

  • A Pharmacist’s Degree required
  •  Requires a minimum of 8 years in Regulatory Affairs in a multinational company , with three years with people management
  •  High commitment to quality of all projects. A “do what it takes” mindset and positive attitude
  • IT systems competencies and experience with MS Office applications as you will be responsible for managing data entry and electronic filing in our various databases and document management systems
  • Keen attention to detail and skill in reviewing to ensure accuracy
  • The ability to cope and work effectively within an environment that has quickly changing processes and procedures
  •  The ability to manage multiple projects simultaneously
  •  The ability to work effectively and efficiently under deadlines
  • Willingness and ability to implement action plans without being told to do so
  •  Excellent knowledge of local legislation. Regional legislation awareness desirable
  • Fluency in written and spoken Arabic, French and English is a must.

 

Working at Novo Nordisk:

  • At Novo Nordisk, your skills, dedication and ambition help us change lives for the better for patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life.
  • In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

 

  • Nom de l'entrprise ALDAPH
  • Secteur d'activité Industries
  • Lieu de travail Alger, Algérie
  • Date d'expiration 30 Septembre
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Confirmé / Expérimenté
  • Niveau d'étude (diplome) Master 2, Ingéniorat, Bac + 5

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