Associate Regulatory Affairs
hace 2 meses
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.
Associate Regulatory Affairs
Live
What you will do
Key responsibilities include, but are not limited to:
- Coordinate the main activities for the submission of the Life Cycle Management of product registration like renewals, and product variations.
- To update the dossier in the Amgen ́s systems for the correct traceability of the products.
- To verify that updated labeling are correct for submission (mock-ups) and its implementation (artwork).
- To hand-off the correct source text in the respective Amgen ́s system for the labeling implementation.
- To be aware about the updates in the local regulations and communicate with the main stakeholders.
- To attend the follow-up meetings related with the life cycle management of the product in charge of with International Regulatory Lead (IRL), CMC lead supply, Regional Operation Lead (ROLs), medical, etc.
- Ensure all regulatory submissions are made on time and meet local regulatory requirements. These changes can include but they are not limited to: New MAAs, renewals, labeling updates, technical changes.
- To review, analysis, and respond to questions (RTQ) whenever necessary related to the submitted procedures , and requested by the Health Authority.
- To review promotional and non-promotional materials.
Collaboration
- Request and provide legal documents when needed to the regulatory procedure.
- Update and keep current the applicable databases needed for the latam RA department.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The professional we seek has these qualifications.
Basic Qualifications:
- Bachelor's degree Or
- Associate's degree and 4 years of experience in similar positions on a big pharmaceutical company Or
- High school diploma / GED and 6 of experience in similar positions on a big pharmaceutical company.
- Proficiency in English, both in oral and written communication.
THRIVE
Some of the vast rewards of working here
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, improve your expertise, and maximize your potential along your career journey.
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
- Generous Total Rewards Plan—comprising health, finance and wealth, work/life balance, and career benefits—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor.
Apply now
for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
-
Regulatory Affairs Specialist
hace 9 horas
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 9 horas
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 11 horas
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
hace 10 horas
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...
-
Regulatory Affairs Manager
hace 10 horas
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 12 horas
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 Specialist
hace 11 horas
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 10 horas
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 11 horas
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...
-
Senior Regulatory Affairs Specialist
hace 8 horas
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 9 horas
Ciudad de México, Ciudad de México ICON Plc A tiempo completoJob SummaryICON 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 ResponsibilitiesRegulatory ComplianceLead the preparation, submission, and...
-
Regulatory Affairs Specialist LATAM
hace 9 horas
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 9 horas
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 Manager II
hace 11 horas
Ciudad de México, Ciudad de México Mccormick & Company A tiempo completoJob SummaryMccormick & Company, a leading manufacturer and distributor of spices, seasonings, and condiments, is seeking a highly skilled Regulatory Affairs Manager II to join our team in Mexico City, Mexico.About the RoleThe successful candidate will be responsible for leading a team of regulatory professionals who will develop and implement regulatory...
-
Regulatory Affairs Director
hace 10 horas
Naucalpan de Juárez, México Merck Group A tiempo completoAbout the Role:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Merck Group. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with local regulations and guidelines for our pharmaceutical products and medical devices.Key Responsibilities:Develop and implement regulatory strategies...
-
Regulatory Affairs Director
hace 8 horas
Naucalpan de Juárez, México Hydro - US Facilities A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Hydro - US Facilities. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to achieve regulatory approvals.Key ResponsibilitiesDevelop and implement regulatory strategies for...
-
Regulatory Affairs Specialist
hace 10 horas
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 9 horas
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 Manager
hace 3 semanas
Ciudad de México, Ciudad de México Fyte A tiempo completoRegulatory Affairs Manager CDMX En Fyte estamos en búsqueda de un Regulatory Affairs Manager para una empresa farmacéutica internacional Buscamos conectar con Profesionales con al menos 10 años de experiencia laboral en Asuntos Regulatorios para la industria farmacéutica. ¿Qué responsabilidades tendrás?Asegurar que todos los productos y procesos...
-
Regulatory Affairs Specialist
hace 8 horas
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...
