Regulatory Affairs Manager

ALGER

  • Catégories: Stratégie & Management
  • Wilaya: ALGER
  • Publiée le: 25-12-2023 à 11:08:56
Description
Mission :
  • Prepare, submit, and ensure appropriate follow-up for new marketing authorization applications with local authorities for assigned products.
  • Ensure timely submission of modifications, renewal requests, and additional marketing authorizations for authorized assigned products.
  • Provide timely, accurate, and compliant translations of labeling and illustrations for assigned products.
  • Continuously ensure compliance with local regulatory requirements as well as company policies and procedures.
  • Demonstrate clear leadership in shaping the regulatory environment to support subsidiary objectives.
  • Collect relevant publicly accessible regulatory information (regulatory intelligence) and keep stakeholders properly informed.
  • Collaborate with the Commercial Affairs team at local, regional, and global levels to support product-related business initiatives.
  • Facilitate the release of commercial shipments by sending appropriate documents to distributors in a timely manner.
  • Coordinate labeling activities and work closely with registration managers to ensure timely submissions.
  • Update all regulatory databases.
  • Support local activities by reviewing and submitting promotional material and events.
  • Collaborate with various local departments, including Supply Chain, Market Access, Business, Medical Finance, etc.
  • Maintain positive relationships with internal and external regulatory contacts.
  • Continuously ensure compliance with local regulatory requirements and internal policies and procedures.
  • Provide administrative support to the Regulatory Affairs department to internal and external stakeholders, including the finance department and suppliers


Profil :
  • Bachelor's degree in Pharmacy.
  • Over 3 years of experience in the pharmaceutical industry.
  • At least 2 years of relevant experience in Regulatory Affairs.
  • Excellent proficiency in French and Arabic.
  • Fluent in English.
  • Strong organizational skills.
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