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Emploi par regions
Référence : NOVO -34Vue : 628 fois - Expire le 04 Mars 2018
Entreprise :

Secteur :

Localisation :
Algérie, Alger.

Fonction :
Juridique Fiscal

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Regulatory Affairs Specialist

Description du poste

Based in Algiers with responsibility for Algeria
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 Regulatory Affairs Specialist with an interest in working with Life Cycle Management (LCM) activities to join our Regulatory Affairs department.
About Novo Nordisk Algeria
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 strategy for Novo Nordisk. You will report directly the Head of Regulatory Affairs.
As Regulatory Affairs Specialist you will coordinate and supervise Regulatory Affairs applications related to product Life Cycle Management (LCM) and/or New Drug Approvals (NDA). Develop, review and update labelling and ensure RA compliance in promotional material according to local legislation and Standard Operation Procedures (SOPs).
You will be administratively responsible for preparing, compiling and submitting documentation to Health Authorities and in ensuring approvals. You will also be handling various requests from internal functions and other stakeholders. You will work in a fast paced environment with tight deadlines and you will be supported by friendly colleagues.


A Pharmacist’s Degree required
Requires a minimum of 3 years of progressively responsible, relevant experience from working in Regulatory Affairs in a multinational company
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.
For further information, please contact Mehdi Amazouz at +213 23 53 15 31
20 December 2017.

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