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Itaietzi Olivar Pineda
Regulatory Affairs Coordinator
Mexico City,CMX
Summary
Experienced Regulatory Affairs Coordinator with over 8 years in the pharmaceutical and medical device sectors, specializing in regulatory information management. Proven ability to streamline regulatory processes, ensure compliance with industry standards, and drive efficiency across diverse projects.
Demonstrated expertise in managing and integrating regulatory dossiers, optimizing submission workflows, and implementing new guidelines for dossier building. Skilled in leading MAT projects, improving document management systems, and collaborating effectively with cross-functional teams.
Adept at maintaining communication channels with regulatory bodies and stakeholders, facilitating smooth transitions, and aligning strategies to address regulatory challenges. Committed to upholding high regulatory standards and contributing to the successful execution of regulatory strategies
Overview
9
9
years of professional experience
Work History
Regulatory Affairs Coordinator
Viatris Mexico
06.2023 - Current
- Enhanced regulatory compliance by developing and implementing effective policies and procedures.
- Coordinated responses to inquiries from regulatory authorities, demonstrating professionalism and expertise in addressing concerns.
- Streamlined submission processes for improved efficiency and reduced submission timelines.
- Collaborated with cross-functional teams to ensure timely delivery of regulatory documents.
- Used VeevaVault to review and approve promotional materials.
- Assisted Viatris in becoming the first company to submit digital advertising notices (DIGIPRIS), setting a new standard in digital compliance.
- Managed the Marketing Authorization Transfer (MAT) from 2 companies, facilitating a seamless transition between organizations.
- Proactively monitored BoH activities, expediting approval processes through digital submissions, direct communication, and participation in training sessions, reducing approval delays by 42%.
- Successfully managed and submitted 87% of the Marketing Authorization Transfer project with minor delays, ensuring overall progress and compliance
- Trained 100% new colleague for Regulatory Affairs activities
- Facilitated communication between departments to ensure a seamless flow of information related to regulatory affairs.
Regulatory Affairs Analyst
Viatris Mexico
11.2021 - 06.2023
- Submitted dossiers to TPR or BoH within agreed timelines, maintaining compliance and supporting product approvals.
- Monitored BoH activities to expedite approvals, including managing ECAR, digital submissions, and direct communication to address delays.
- Managed the control and availability of legal documents (GMP and CPP) to ensure compliance with local regulations, maintaining up-to-date records for API and DP manufacturers and packaging sites across all portfolios.
- Harmonized and reviewed labeling documents to enhance the quality of information provided to BoH and healthcare professionals, improving product safety and communication.
- Collaborated actively with Marketing and Medical teams during the advertising materials review and approval process, ensuring regulatory compliance.
Regulatory Affairs Analyst
Pfizer (Upjohn Division)
01.2020 - 11.2021
- Compiled and submitted regulatory dossiers to TPR or BoH, adhering to strict timelines and ensuring compliance with regulatory standards.
- Actively monitored BoH activities, including digital submissions and training sessions, to expedite the approval process and mitigate delays.
- Controlled and managed legal documents (GMP and CPP) to ensure full compliance with local regulations, maintaining availability of valid documents for all portfolios.
- Played a key role in labeling harmonization and document review, improving the accuracy and quality of information submitted to BoH and healthcare providers.
- Collaborated closely with Marketing and Medical teams to review and approve advertising materials, ensuring alignment with regulatory requirements and corporate standards.
Regulatory Affairs Analyst
Accord Farma
08.2019 - 01.2020
- Compiled and submitted regulatory documents in accordance with regulatory requirements, ensuring adherence to deadlines and accuracy.
- Took appropriate regulatory actions to respond to BoH questions, meeting strict deadlines and maintaining compliance.
- Assisted in post-market surveillance activities, ensuring ongoing compliance and safety monitoring.
- Compiled and managed information and data related to regulatory submissions and compliance.
Regulatory Affairs Analyst
Dewimed
01.2019 - 08.2019
- Supported the introduction of medical devices to the Mexican market, ensuring compliance with regulatory requirements and conducting post-market surveillance.
- Evaluated the effects of amendments and changes on regulatory compliance and market introduction, facilitating smooth transitions.
- Prepared and submitted regulatory file applications and supporting documentation.
- Implemented regulatory guidance procedures for medical devices.
Regulatory Affairs Trainee
Dräger Mexico
06.2015 - 07.2016
- Learned new materials, processes, and programs quickly.
- Participated in on-the-job training, working closely with supervisors and coworkers and asking appropriate questions.
- Assisted and supported in-house teams with regulatory activities, maintaining current and accurate files.
- Assisted in service and supply chain audits, ensuring compliance and identifying areas for improvement.
Education
Certification - Health Regulation And Risks
Instituto Nacional De Salud Pública
Mexico City, Mexico 05.2001 -
Master’s Degree - Biochemistry
Universidad Nacional Autónoma De México, México
Mexico City, Mexico 05.2001 -
Bachelor’s Degree - Biotechnology Engineering
Instituto Politécnico Naciona
Mexico City, Mexico 05.2001 -
Skills
Regulatory Submissions
Document Management
Policy analysis
Pharmaceutical industry knowledge
Stakeholder Communication
Global Regulatory Compliance
Product Lifecycle Management
Teamwork and Collaboration
Problem-Solving
Time Management
Adaptability and Flexibility
Software
Languages
Spanish
Bilingual or Proficient (C2)
English
Advanced (C1)
Timeline
Regulatory Affairs Coordinator
Viatris Mexico
06.2023 - Current
Regulatory Affairs Analyst
Viatris Mexico
11.2021 - 06.2023
Regulatory Affairs Analyst
Pfizer (Upjohn Division)
01.2020 - 11.2021
Regulatory Affairs Analyst
Accord Farma
08.2019 - 01.2020
Regulatory Affairs Analyst
Dewimed
01.2019 - 08.2019
Regulatory Affairs Trainee
Dräger Mexico
06.2015 - 07.2016
Certification - Health Regulation And Risks
Instituto Nacional De Salud Pública
05.2001 -
Master’s Degree - Biochemistry
Universidad Nacional Autónoma De México, México
05.2001 -
Bachelor’s Degree - Biotechnology Engineering
Instituto Politécnico Naciona
05.2001 -
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