Regulatory Affairs Specialist

JR097045

Regulatory Affairs Specialist

Site: Mexico, Benito Juarez

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Overview:
The Regulatory Affairs fulfills the role of Local Regulatory Affairs Lead and is responsible for preparing, submitting

and following up on initial and amended Regulatory Agency, Central Independent Ethics Committee (IEC), and any other central

submissions required in the country(s) they are responsible for, within contracted timelines and budget, in accordance with local regulatory

requirements and sound scientific/technical principles, including the creation and modification of documentation required for approval. Is responsible for the provision of information relating to local importation and exportation requirements. Where locally appropriate they

may be responsible to carry out all practical steps to ensure that importation and exportation requirements are met for Investigational

Product (IP) and any other clinical trial supplies needed for the trial within their country. The RA is also responsible for providing review of

the translation into the local language of clinical trial supply labeling to ensure it meets local regulatory requirements. Additionally the RA

will ensure that Insurance Certificates, Country Specific Informed Consent forms and any other patient documentation adheres to country

requirements. The RA may be responsible for activities related to product registration maintenance.

**Responsibilities**:

- Management of activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities for the assigned country/ countries.
- Management of central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the RAS is responsible for.
- Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
- Management of the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA and Central IEC as appropriate.
- Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.
- Perform role of Local Reviewer in the QC process as appropriate.
- Providing consultancy to the client on any country specific issues if requested by the Start-Up Lead (SUL), GRAL, Clinical Team Manager (CTM) or Project Manager (PM)
- Supporting the senior level Regulatory staff/Country Consultant in the maintenance of the accurate, up to date Country Knowledge Repository.
- Attending internal and external project team meetings as determined by the GRAL, SUL, CTM or PM.
- If applicable for the Country, submit expeditable safety reports to RAs and central IECs in accordance with relevant legislation and the project-specific contractual agreement.
- Any other duties deemed necessary to secure the success of PRA’s business.
- Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs.
- 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; communicate new information or changes to the Regulatory Intelligence Consultant team.
- May work with GRA team members to provide Regulatory consulting services.
- May support, prepare and review GMP and product (drug products, medical devices, cosmetics, food, supplement) submissions for product registration and maintenance to Regulatory Agencies with appropriate oversight, supports labeling (leaflet, primary and secondary packaging) and promotional material activities based on relevant regulations and updates regulatory systems accordingly.

Qualifications:
You will need:
1-2 years of experience

Degree on any Biosciences Area

MoH/CEC submissions in Mexico exp.

ICF adaptation proces