Detalles del puesto

Regulatory Affairs Manager

Distrito Federal   •   MXN55,000 - MXN70,000   •  Permanente

Bullet points

  • Sanitary Responsible, Regulatory Affairs, and PV Manager
  • 5 years of working experience in pharmaceutical regulatory affairs

Detalles del cliente

Multinational pharmaceutical group.

Descripción de la vacante

Reporting to the General Manager of the Subsidiary, and functionally to the Corporate Regulatory Affairs Department located in the headquarters, the main responsibilities are to:

  • Be in charge for regulatory activities related to the registration of new products and for maintaining the registration of the existing ones, with the support of local consultants if needed.
  • Supervise pharmaco-vigilance activities and be the health responsible for the subsidiary before Cofepris.
  • Keep informed about all current/new national regulations/requirements having consequences for the current and future registrations.
  • Follow-up and coordinate all regulatory activities.
  • Ensure that the products are marketed in compliance with the applicable laws.
  • Analyze the documentation prepared by Corporate RA Department, validate its compliance with local requirements and determine if it is suitable for submission.
  • Submit all regulatory dossier to the regulatory authorities.
  • Obtain new registrations and keep valid the existing ones (variations, renewals).
  • Reformat and manage the necessary translations and notarizations.
  • Prepare any specific document required by local regulations.
  • Maintain all product information up to date, in compliance with the market authorization.
  • Validate the compliance of all packaging and labelling items with the applicable laws.
  • Manage the importation permits (submission, renewal).

Perfil del candidato

5 years of working experience in Pharmaceutical Regulatory Affairs, PV or as a Sanitary Responsible, preferably in a multinational company. Scientific background (Chemist, Biologist, Pharmacist, or related). Qualifications/experience required to be "Responsable Sanitario" for the Mexican affiliate before Cofepris. Specialization in drug regulation will be highly appreciated and knowledge in medical device, and cosmetics regulations will be a plus. Excel, Word, and Outlook abilities. Adaptability in a fast-paced start-up environment highly desirable. Flexibility and ability to quickly adapt to changes. Excellent written and oral communication, and strong organizational skills. Positive attitude. Fluent English.

Oferta de empleo

  • Attractive compensation package and benefits.

Aplicar para esta vacante

Si cumples con el perfil y experiencia profesionales requeridas puedes postularte haciendo click en el botón de Aplicar o a través de tu perfil de LinkedIn. El número de referencia para esta vacante es 32247. Tu CV será analizado por Manuel Ferrero.
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