Regulatory Affairs Expert

hace 4 semanas

Colombia ENGINEERINGUK A tiempo completo
Job Title: Regulatory Affairs Specialist

About the Role:

This role will be joining our Regulatory Affairs team, working with a global pharmaceutical client that creates value through innovation. The team is responsible for managing activities associated with obtaining initial, amendment and other central authority approvals, and performing submission and maintenance of new health records, renovations, and modifications to keep the products on the market according to the strategic plan established by the company, current Colombian laws, and current local health legislation.

Key Responsibilities:
  • Manage activities associated with obtaining initial, amendment and other central authority approvals e.g. Regulatory Agency (RA), and any other central authorities for the assigned country/countries.
  • Perform submission and maintenance of new health records, renovations, and modifications to keep the products on the market according to the strategic plan established by the company, current Colombian laws, and current local health legislation in accordance with the corporate guidelines and policies.
  • Prepare and attend meetings with INVIMA (MoH) and/or the entity designated by the Government and associations for the processing of products for human use of its therapeutic line(s).
  • Review promotional materials for products for human use of their therapeutic line(s) in Veeva Vault or current tool.
  • Perform submission and monitoring of products for human use of their therapeutic line(s) in procedures such as: PSUR, DSUR, RMPs, and safety information according to current Colombian regulations.
  • In case of having products for human use of therapeutic line(s) and of special control of the Fondo Nacional de Estupefacientes (FNE), be in charge of sending reports to the Fondo Nacional de Estupefacientes (FNE) in the times established by Colombian law.
  • Back-up to the Head of Regulatory Affairs and analysts of records in the procedures of INVIMA in order to guarantee the operation of the area.
  • Ensure that IP labels are in adherence to country requirements and submitted where applicable.
  • Support the senior level regulatory staff/country consultant in the maintenance of accurate, up-to-date Country Knowledge Repository.
  • Contribute to the maintenance and collection of regulatory intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up-to-date and communicate new information or changes to the Regulatory Intelligence Consultant team.
  • Attend project team meetings as determined by the working team.
  • Preparation of electronic regulatory submission of post-registration requests, HMPs, labeling notifications, additions, publication corrections, and database corrections, among other petitions to be filed at MoH.
  • Follow-up on the status of the regulatory submissions (paper dossiers) from dispatch to the receipt of proof of protocol.
  • Upload documents in the Documentum system, together with the proof of protocol and file number.
  • Complete control spreadsheets regarding MoH submissions performed.
  • Detail the package insert for registration cases and in case of post-registration, evaluate impact on packaging materials.
  • After the publication, send packing materials with the registration numbers to the supply team. For products with standard package insert (generic/similar), assess whether the package insert is suitable for the latest version of the package insert.
  • Understand regulations applicable to products (drug products, medical devices, cosmetics, food supplements, etc.) for registration or post-approval.
  • May work with the regulatory team to assist and prepare other related activities such as:
    • DMF dossiers
    • Prepare and dispatch deficiency letter registrations
    • Amendments
    • GMP inspection requests to MoH/deficiency letter GMP if requested or GMP amendment if needed
    • Annual report and renewal dossier for each product, post-approval change dossiers

About You:

We are looking for a highly skilled and motivated individual with a Bachelor's Degree in Pharmaceutical Chemistry, technical knowledge in the preparation of a dossier, previous experience in the regulatory area (minimum 1 year), knowledge of current ICH and local regulations as they relate to pharmaceutical, biological, biosimilar, and medical device product development and registration, and prior experience using computerized information systems. The ideal candidate will have excellent communication and teamwork skills, and the ability to work in a fast-paced environment with multiple priorities.

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