Regulatory Affairs Specialist

As a Regultory Affairs Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with a global pharmaceutical client that creates value through innovation with a clear goal: to provide more health and improve the lives of both humans and animals.

What you will be doing:

• Manage activities associated with obtaining initial, amendment and other central authority approvals e.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, procedures and premises.
• 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 of 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

You are:

• Bachelor's Degree in Pharmaceutical Chemist.
• Technical knowledge in the preparation of a dossier is a plus
• 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.
• Knowledge or awareness of current regional guidelines and regulations is preferred, as well as the ability to understand new guidelines and regulations as they are issued by major regulatory authorities in the region.
• Prior experience using computerized information systems required; experience with PC Windows, word processing, and electronic spreadsheets required.
• All employees must read, write and speak fluent English and host country language.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.