Regulatory Affairs Coordinator
hace 3 meses
**Function/Mission**:
- Coordinate all the required activities for label update based on reference label in order to submit to the local Health Authority according to KPIs timelines.
- Execute the review and approval process of advertising, promotional materials and nonpromotional materials in compliance with the applicable regulations and company policies.
- Coordinate all the required activities with Area Therapeutic Area Teams to ensure the availability GMPc issued by the local Health Authority for the applicable products/manufacturing sites.
- Control and guard of GMPs, CPPs, PoAs, LoAs, and other legal documents.
submission dates with MKT.
**Responsibilities**:
- Review and validate the translation to Spanish of documents translated by Area and local translations.
- Coordinate the translation to Spanish of the technical, legal and/or clinical support documentation provided by global.
- Prepare, review and integrate the files for the submission to the local Health Authority.
- Ensure the dossier meets with the local requirements according to the corresponding regulations.
- Execution of the activities required for the Subcommittee of Evaluation of Biotechnology Products & New Molecules Committee presentation.
- Give a close follow up to internal activities needed for the review & approval of administrative & technical variations.
- Develop the local labeling texts ensuring that they meet with local regulations, internal SOP and the reference document provided by AREA.
- Drive labeling process for creating new or updating previous artworks for the pharmaceutical, biotechnological & biological products, as initiator and/or reviewer.
- Ensure that the GMPs and other legal regulatory documents of manufacturing sites are valid during the entire lifecycle of the marketing authorization. Applicable for documents issued by the local Health Authority or other regulatory agencies.
- Maintain the archive of the GMPs, CPPs, PoAs, LoAs, and other legal documents and maintain the control of the documents ensuring that the originals are kept and ensure there is always available at least one certified copy of each document and request new certified copies to the Administrative Assistant.
- Keep updated the tracking database and due dates for the request of the GMPs, CPPs, PoAs, LoAs, and other legal documents to the GSSC.
- Review of advertising and promotional material in Veeva and submission to Cofepris.
- Prepare, submit and obtain the approval for local biological product release.
- Participate in the assigned meetings internally and externally.
- Execute all the activities described in alignment with AbbVie culture and philosophy.
- Keep updated the applicable SOP.
**Qualifications**:
- 2 to 5 years in a similar position.
- Pharmacist, Biotechnology Engineer, Pharmaceutical Engineer or related demonstrable professional degree.
- Knowledge in Health regulation in Mexico.
- Good communication skills.
- Good relationships with internal stakeholders.
- Continuous tracking of self and other activities.
- Fluent in English written and spoken.
-
Regulatory Affairs Specialist
hace 1 semana
Ciudad de México, Ciudad de México Fenixfarma Mexico City, Mexico A tiempo completo{"h1": "Regulatory Affairs Coordinator", "p": "Fenixfarma Mexico City, Mexico is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with local health regulations and leading a team of regulatory specialists to achieve product...
-
Regulatory Affairs Coordinator
hace 1 semana
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. In this role, you will be responsible for coordinating and managing regulatory submissions, site contracts, and site documents across various regions. If you have a strong background in office administration and a...
-
Regulatory Affairs Specialist
hace 1 semana
Ciudad de México, Ciudad de México Solventum A tiempo completo{"title": "Regulatory Affairs Coordinator", "description": "Job Overview:Solventum is seeking a highly skilled Regulatory Affairs Coordinator to join our team. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with regulatory requirements for our medical devices.Key Responsibilities:Review and support...
-
Regulatory Affairs Specialist
hace 3 semanas
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 Coordinator
hace 2 semanas
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...
-
Regulatory Affairs Coordinator
hace 3 semanas
Victoria de Durango, Durango, México Healthcare Businesswomen'S Association A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team at the Healthcare Businesswomen's Association. As a key member of our regulatory team, you will be responsible for ensuring compliance with current regulatory obligations and requirements.Key ResponsibilitiesRegulatory Transmission: Serve as the single point of contact...
-
Regulatory Affairs Specialist
hace 3 semanas
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 2 semanas
Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completoRegulatory Affairs SpecialistThermo 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 completoRegulatory Affairs SpecialistThermo 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 play a critical role in leading communications with regulatory agencies and providing regulatory affairs strategy and technical/project leadership on a regional/global...
-
Regulatory Affairs Specialist
hace 3 semanas
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 3 semanas
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 1 semana
Naucalpan de Juárez, México Hydro - US Facilities A tiempo completoUnlock Your Potential in Regulatory AffairsAt Hydro - US Facilities, we're passionate about creating innovative solutions that enrich people's lives. As a Regulatory Affairs Manager, you'll play a crucial role in helping us achieve our mission.About the RoleWe're seeking a seasoned Regulatory Affairs professional to join our team. As a key member of our...
-
Regulatory Affairs Specialist
hace 5 días
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoRegulatory Affairs OfficerWe are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring the delivery of regulatory activities on a global level.Key Responsibilities:Contribute to the production of client administrative documents for regulatory...
-
Regulatory Affairs Specialist
hace 1 semana
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoRegulatory Affairs OfficerProductLife Group is seeking a highly skilled Regulatory Affairs Officer to manage post-MAA activities for the Canadian market.ResponsibilitiesManage post-approval activities (Life Cycle Management) for the Canadian market, ensuring compliance with Health Canada guidelines.Initiate change controls, including regulatory assessments...
-
Regulatory Affairs Expert
hace 1 semana
Ciudad de México, Ciudad de México 520 ICR Mexico - MEX A tiempo completoSenior Regulatory Affairs SpecialistAbout the RoleWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at 520 ICR Mexico - MEX. As a key member of our regulatory affairs team, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.Key...
-
Regulatory Affairs Specialist
hace 1 semana
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoRegulatory Affairs Officer Job DescriptionWe are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group.Key Responsibilities:Contribute to the production of client administrative documents for regulatory submissionsCompile regulatory dossiers in accordance with national requirementsManage systems and administer regulatory...
-
Regulatory Affairs Specialist
hace 7 horas
Ciudad de México, Ciudad de México ProductLife Group A tiempo completoRegulatory Affairs Officer Job DescriptionWe are seeking a highly skilled Regulatory Affairs Officer to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring the delivery of regulatory activities on a global level.Responsibilities:Contribute to the production of client administrative documents for...
-
Regulatory Affairs Coordinator
hace 1 semana
Victoria de Durango, Durango, México Novartis Farmacéutica A tiempo completoAbout the Role:As a Regulatory Affairs Coordinator at Novartis Farmacéutica, you will play a critical role in ensuring the timely supply of products to the market while maintaining compliance with current regulatory obligations and requirements.Key Responsibilities:Regulatory Transmission: Serve as the single point of contact for worldwide regulatory...
-
Regulatory Affairs Director
hace 3 semanas
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 Director
hace 3 semanas
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...