Regulatory Affairs Specialist
hace 5 días
Job Summary
ICON Plc is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a pivotal role in ensuring regulatory compliance and facilitating the successful execution of clinical trials.
Key Responsibilities
- Regulatory Compliance
- Lead the preparation, submission, and maintenance of regulatory documents for clinical trials.
- Provide expertise and guidance on regulatory requirements and standards to internal teams.
- Interface with regulatory agencies to address inquiries, submissions, and approvals.
- Monitor changes in regulations and guidelines to ensure compliance and mitigate risks.
- Collaborate cross-functionally to support regulatory aspects of clinical trial planning and execution.
- Communicate effectively with internal stakeholders to ensure regulatory compliance.
Requirements
- Education
- 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.
- 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.
What ICON Plc Offers
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 Plc 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.
ICON Plc, 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, colour, 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 Plc whether it is for this or other roles.
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoJob SummaryThermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Liaison team. As a key member of our team, you will be responsible for leading communications with regulatory agencies and providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo**Job Summary**Thermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Liaison team, you will be responsible for leading on communications with regulatory agencies as part of centralized regulatory submissions.**Key Responsibilities**Provide regulatory advice and carry out...
-
Regulatory Affairs Specialist LATAM
hace 5 días
Ciudad de México, Ciudad de México Medtronic A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Medtronic. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices in the LATAM region.Key ResponsibilitiesCoordinate and prepare document packages for regulatory submissions,...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México Philips Iberica SAU A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Philips Iberica SAU. As a key member of our Regulatory Affairs team, you will be responsible for guiding and supporting our businesses, markets, and supporting functions in the Mexico market to ensure compliance with regulatory requirements.Key...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México Fenixfarma Mexico City, Mexico A tiempo completoJob Title: Regulatory Affairs CoordinatorCompany: Fenixfarma Mexico City, MexicoJob Summary:We are seeking a highly skilled Regulatory Affairs Coordinator to join our team in Mexico City. The successful candidate will be responsible for ensuring compliance with local health regulations and leading a team of regulatory specialists to achieve product...
-
Senior Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México Icon plc A tiempo completoJob SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ICON plc. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.Key ResponsibilitiesRegulatory Document Preparation...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México QuidelOrtho A tiempo completoAbout the OpportunityQuidelOrtho, a world-leading in vitro diagnostics company, is seeking a highly skilled Regulatory Affairs Associate to join our team. With a strong presence in over 130 countries, we provide fast, accurate, and consistent testing solutions where and when they are needed most.Our company culture prioritizes employee happiness,...
-
Regulatory Affairs Specialist
hace 4 días
Ciudad de México, Ciudad de México Kenvue A tiempo completoAbout KenvueKenvue, part of the Johnson & Johnson Family of Companies, is a leading healthcare company that believes in the extraordinary power of everyday care. With a rich heritage and propelled forward by science, our iconic brands are trusted by millions of consumers who use our products to improve their daily lives.Job SummaryWe are seeking a highly...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México MMATISS A tiempo completoKey Responsibilities:As a Regulatory Affairs Coordinator at MMATISS, you will be responsible for ensuring compliance with local regulations by performing submissions and tracking the progress of approvals. You will implement regulatory processes to avoid warnings or rejections, including obtaining protocol, site, marketing, and importation/exportation...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México GSK A tiempo completoRegulatory Affairs Specialist Role at GSKThis position is responsible for coordinating activities related to compliance with the Regulatory Framework in Mexico, aligned to the needs and strategies defined by the different participating areas of GSK, focused on the submission and approval of administrative and technical modifications.Key...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México Procter & Gamble A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Procter & Gamble. As a key member of our regulatory team, you will be responsible for preparing and approving submission-ready documents for renewals, variations, or rollouts, maintaining existing product licenses for medicinal products or Food Supplements, and...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for pharmaceutical products in Mexico and Central America.Key ResponsibilitiesRegulatory Guidance and Support: Provide expert...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México Psi CRO Ag A tiempo completoAt Psi CRO Ag, we are seeking a highly skilled Regulatory Officer to join our team of experts in regulatory and ethics submissions of clinical studies.Key ResponsibilitiesPrepare clinical trial submission dossiers for regulatory and ethics authorities, ensuring compliance with all relevant regulations and guidelines.Communicate effectively with regulatory...
-
Regulatory Affairs Specialist
hace 4 días
Ciudad de México, Ciudad de México Kenvue A tiempo completoAbout the RoleKenvue, a leading healthcare company, is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with regulatory agency regulations and guidelines.Key ResponsibilitiesDevelop and maintain regulatory strategies and...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México Icon Plc A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Icon Plc. As a key member of our Regulatory Submissions team, you will play a critical role in ensuring the timely and accurate preparation, compilation, and submission of regulatory documents to various authorities.Key ResponsibilitiesPreparation and submission...
-
Regulatory Affairs Manager
hace 5 días
Ciudad de México, Ciudad de México Upfield A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Upfield in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements in Central and Latin America.Key ResponsibilitiesDevelop and implement regulatory strategies to support product...
-
Regulatory Affairs Manager
hace 3 días
Ciudad de México, Ciudad de México Gilead Sciences A tiempo completoJob DescriptionWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Gilead Sciences. As a Regulatory Affairs Manager, you will play a critical role in advancing our therapeutics and ensuring regulatory compliance.Key ResponsibilitiesDevelop and Execute Regulatory Strategies: Define, develop, and execute...
-
Regulatory Affairs Manager
hace 5 días
Ciudad de México, Ciudad de México Gilead Sciences, Inc. A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences, Inc. in Mexico City. As a key member of our Regulatory Affairs team, you will play a critical role in advancing our therapeutics and ensuring regulatory compliance.Key ResponsibilitiesRegulatory Strategy DevelopmentDefine and execute regulatory...
-
Regulatory Affairs Manager
hace 4 días
Ciudad de México, Ciudad de México Gilead A tiempo completoAbout GileadGilead is a leading biopharmaceutical company dedicated to creating a healthier world for all people. With over 35 years of experience, we have developed therapies that improve lives and ensure access to these therapies across the globe.We are a collaborative and ambitious team that tackles the world's biggest health challenges. Our employees are...
-
Regulatory Affairs Coordinator
hace 3 días
Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completoJob SummaryWe are seeking a highly organized and detail-oriented Regulatory Affairs Coordinator to join our team at Worldwide Clinical Trials. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the smooth operation of our regulatory processes.Key ResponsibilitiesRegulatory Submissions: Coordinate and manage the...