JR104758
Senior 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 Senior Regulatory Affairs Specialist has responsibility for providing comprehensive regulatory services to clients within the pharmaceutical, biologic, medical device or other regulatory services environments. This will include support for assessment, registration, maintenance and other activities as assigned.
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 LRAA 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 specifics 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.
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 liaise with team/other department members to validate Country Intelligence before liaising with the appropriate GRA team member to ensure that the information is disseminated appropriately.
- 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:
2 years of experience
Degree on any Biosciences Area
MoH/CEC submissions in Mexico exp.
ICF adaptation process exp.
Labeling review exp.
Advanced English for Reading / Writing / Speaking
Desirable: e-systems knowledge on CTMS, PhlexEview, PSO, BOX
Note: Partial home based: 40% office/60% Home Based
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That is why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.
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