ICON Plc | Senior Regulatory Affairs Specialist with Experience in Clinical Trials | méxico
hace 4 semanas
Senior Regulatory Affairs Specialist with Experience in Clinical Trials
Site: Mexico City
Office with Flex: 3 days at office and 2 days at home
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 be doing
- Leading the preparation, submission, and maintenance of regulatory documents for clinical trials.
- Providing expertise and guidance on regulatory requirements and standards to internal teams.
- Interfacing with regulatory agencies to address inquiries, submissions, and approvals.
- Monitoring changes in regulations and guidelines to ensure compliance and mitigate risks.
- Collaborating cross-functionally to support regulatory aspects of clinical trial planning and execution.
- 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.
- Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
- Provide consultancy to the client on any country specific issues.
- Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs.
- Adaptation of Informed Consent Form according to local regulations.
- Provide mentoring and training to other entry level positions if needed.
Your profile
- Bachelor's degree in a scientific or related field; advanced degree preferred.
- Minimum of 2 years of experience in regulatory affairs within the pharmaceutical or biotech industry. Experience in Clinical Trials.
- Strong knowledge of global regulatory requirements and guidelines for clinical trials.
- Proven ability to manage regulatory submissions and interactions with regulatory agencies.
- Excellent communication, attention to detail, and problem-solving skills.
- Advanced English for Reading / Writing / Speaking.
- Desirable: e-systems knowledge on CTMS, PhlexEview, PSO, BOX.
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.
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.
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.
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.
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