Regulatory Affairs Specialist

Regulatory Affairs - office based - Bogota

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What You Will Do:

Your role will involve delivering regulatory affairs work to a high standard, working closely with your team and stakeholders.

Key responsibilities include:

• Manage activities associated with obtaining initial, amendment and other central authority approvals i.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.
• 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.
• 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 repositor.
• 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.
• Preparation of electronic regulatory submission of post-registration requests, HMPs,
• Labeling notifications, additions, publication corrections and database corrections, among other petitions to be field 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.

Your Profile:

You will bring relevant regulatory affairs experience, along with the following qualifications and skills.

Required qualifications and experience:

• Bachelor's degree in Pharmaceutical Chemist or next to graduate required.
• Minimum 1 year of experience in regulatory area within the pharmaceutical or biotechnology industry.
• 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.
• Technical knowledge in the preparation of a dossier is desirable.
• Prior experience using computerized information systems required: PC Windows, word processing and electronic spreadsheets.
• Advanced English level.

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.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply