Regulatory Affairs Associate

Pfizer Pharma Algérie Alger, Algérie
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  • Secteur d'activité Industries
  • Date d'expiration 12 Décembre 2016
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Confirmé / Expérimenté
  • Niveau d'étude (diplome) Master 2, Ingéniorat, Bac + 5
  • Type de contrat CDD ou Mission

                                                Regulatory Affairs Associate


Position Purpose:
The PCO based Regulatory Associate, will lead, manage and provide strategic direction and oversight to the Country based PCO teams and above country regulatory teams to develop and execute regulatory strategies and plans for the country.
Organizational Relationship(s) including to whom the position reports (JD Job Title):
• Contractor can report to Country Regulatory Head, Senior Regulatory Manager or to the Regulatory Pharmacist/Manager
• Works closely with local Regulatory team and PCO BU teams in country and other stakeholders as necessary
• Contact with local Health Authorities will be agreed within the country regulatory team

Primary Responsibilities :
• Supports the local PCO team in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management.  Provide strategic regulatory input into WSR global regulatory strategies, thus providing optimal support for meeting local business objectives under Country Regulatory Head.
• Develop strong partnerships with in-country (e.g. BU leads, Market Access, Marketing, Supply Chain) and with above country (e.g. Country Strategists, GCMC Hub, Submission and labeling/artwork Hubs, WSR-EM Therapeutic Area and Regional Teams) to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
• Support the development and enhancement relationships with key external agencies (HA’s/BoH, RKOL’s, etc.).
  Any HA/BoH interface throughout the development and lifecycle of a product will be done under the under Country Regulatory Head.
•  Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems are followed ensuring training in P2L are completed 100% (systems and procedures).  
• Maintain compliance (GDMS, GRS, AT, Quantum, CMC change control, product labelling, etc.) at 100%.
• Where needed, oversee and manage the completion of CTA, NDA and Lifecycle (LC) submissions and approvals as per established WSR-IGPI performance metrics.  


• Scientific Degree.  A higher degree (Pharmacy, BSc) may be an advantage but is not essential.
• Appropriate Regulatory Experience
• Regulatory Affairs Associates (Contractor) – minimum 2-3 years


Regulatory Affairs Associate

Pfizer Pharma Algérie Alger, Algérie

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