Regulatory Affairs Specialist-CMC

Date:  Jul 22, 2022
City:  SAB0 - PHARMA SANT ANDREU DE L

Mission

Obtain and maintain (variations, renewals, line extensions, etc.) authorisations to market Global Products of Almirall which have previously been authorised or are in the process of registration in key countries from the regulatory standpoint (USA, EU, Japan) or which will be marketed by Almirall subsidiaries or any of its partners.

Tasks and Responsibilities

  • Assess the viability of obtaining a new marketing authorisation and/or authorisation for a regulatory change in the country in question, taking into account local requirements, available resources and available documentation.
  • Keep the “Portfolio Almirall’s Database” (PAD) updated according to the current corporate procedure.
  • Participate as an expert on regulatory issues as the representative of corporate Regulatory Affairs in meetings with other company departments, external companies and health authorities.
  • Prepare, compile and manage the approval of the Operating Committee of a Registration Project (RP).
  • Obtain the necessary documentation and compile it for regulatory processing and subsequent delivery to Almirall partners or subsidiaries by the agreed deadlines, ensuring that they are submitted to the health authorities by the established deadlines.
  • Provide support to Almirall subsidiaries or to partners during regulatory processing until resolution of same in the corresponding country. In addition, communicate this to the organisation using the established internal procedures.
  • Register the regulatory procedure, regulatory activities and post-approval commitments, as well as associated regulatory documents, in the regulatory database.
  • Control the registration status of all products under his or her responsibility and maintain the annual plan of all regulatory processing activities to be performed up-to-date.
  • Request implementation of the regulatory changes that affect conditioning materials and participate in the authorisation circuit for same.
  • Provide support to the Regulatory Operations Specialist in the recruitment and hiring of local CROs or local agents if required.
  • Read, understand and monitor any corporate RA SOP applicable to the aforementioned role.

Education

Baccalaureate degree in Biology, Pharmacy, Medicine or Chemistry.

Skills

  • Specific knowledge or prior experience in:
    • Pharmaceutical legislation and international regulatory affairs procedures.
    • Pharmacology, Clinical Toxicology, Pharmaceutical Development, Analysis, Production and Quality Control.
  • High level of English.
  • Other languages will be viewed positively.