• Zone Industrielle Est Boudouaou, Boumerdes
  • Industries
  • De 500 à 999 personnes employés

Regulatory Affairs Manager Consumer

  • Nom de l'entrprise GSK ALGERIE/Glaxosmithkline
  • Secteur d'activité Industries
  • Lieu de travail Alger, Algérie
  • Date d'expiration 11 Janvier 2018
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Manager / Responsable département
  • Niveau d'étude (diplome) Master 2, Ingéniorat, Bac + 5

Job Purpose:

  • The purpose of this regional role based in Algeria is to provide regulatory expertise and to coordinate regulatory activities in Maghreb especially for Algeria and Morocco, regarding the portfolio of products introduced or maintained.
  • In this role the individual will build a network of collaborative relationships within internal functions in GSK Cx and GSK Rx but also with external third parties and regulatory agencies, to ensure all regulatory requirements are met for both new innovation and existing products according to GSK Values. 
  • The role may require the individual to provide specialist regulatory advice across the Category and Function.

 

Job Responsibilities:

For both Algeria and Morocco Consumer products portfolio:

  • Ensure registration and maintenance of dossiers for the full life cycle products including database update, change control regulatory input, CRF preparation in line with the submitted dossiers (EDGE Project) and delivery of high quality regulatory files to agreed timelines.
  • Acts as a Business Partner and provides regulatory advice across sub-Category/significant portfolio on all aspects of drug/cosmetic/devices/foods and supplements (dependent on category) development and regulatory requirements, both current and future.
  •  Initiate and coordinates with local Manufacturer, Marketing team and artworks provider, the artworks change products.
  • Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within Claim and Copy approval process.
  • Provides Regulatory input and makes link with Local manufacturer especially with the QA team to ensure compliance with the Local requirement and files submitted.
  • Oversees compliance in all actions by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to.
  • Maintains the organisation's on-going relationships with regulatory commissions/authorities relating to technical issues. Ensure compliance as required by regulatory commissions/authorities.
  •  Assists Local Responsible Pharmacist in case of Inspection and Audit on the regulatory part for Cx products. Performs audits to ensure that the organisation is in compliance with government laws and regulations.

 

Qualifications:

  • Scientist background (Master degree preferred in
    Biology)
  • 5 years in Regulatory Affairs Pharmaceutical industry

 

Other Job-Related Skills/Background:

  • Fluent in both French & English with large communication skills to negotiate effectively with LOC Health Authorities
  • Entrepreneurial spirit, agility & autonomy
  • Nom de l'entrprise GSK ALGERIE/Glaxosmithkline
  • Secteur d'activité Industries
  • Lieu de travail Alger, Algérie
  • Date d'expiration 11 Janvier 2018
  • Nombre de postes 01 poste ouvert
  • Niveau de poste Manager / Responsable département
  • Niveau d'étude (diplome) Master 2, Ingéniorat, Bac + 5
  • Zone Industrielle Est Boudouaou, Boumerdes
  • Industries
  • De 500 à 999 personnes employés