9 publicaciones de empleo destacadas en regulatory affairs (¡Están contratando!)

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Regulatory Affairs Officer, IQVIA Biotech
IQVIA —Ciudad de México, CDMX
- Administración de personal
- Microsoft Office
- Maestría
Regulatory Affairs Specialist I
Merit Medical —Tijuana, B.C.
- Tiempo completo
- Word processing
- Inglés
- Licenciatura
1d
Technical Services Analyst
Kemin —Zapopan, Jal.
- Tiempo completo
- Ingeniería
- Inglés
- Licenciatura
Sr Associate - Consumer Digital Ecosystem
Eli Lilly —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Inglés
- Disponible para viajar
11d
Diseñador Gráfico Freelance
Innova Talent - Soluciones Humanas —Zapopan, Jal.
- $500 por día
- Por temporada
- Licenciatura
- Trabajo desde casa
Postulación rápida
Senior Clinical Data Engineer (LATAM)
Precision Medicine Group —Desde casa
- Home Office (Desde casa)
- Administración de personal
- Inglés
- SQL
Senior Clinical Data Engineer (LATAM)
Precision for Medicine —Desde casa
- Home Office (Desde casa)
- Administración de personal
- Inglés
- SQL
Postulación rápida
Regulatory Affairs Specialist I
Merit Medical Systems Inc. —Tijuana, B.C.
- Tiempo completo
- Licenciatura
- Mejora continua
- Seguro dental
22h
Patient Access Partner
UCB —Colonia Polanco, CDMX
- Experiencia en ventas
- Licenciatura
- Negociación
1d

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Regulatory Affairs Officer, IQVIA Biotech

IQVIA -
Ciudad de México, CDMX

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Información del empleo

Cualificaciones

Administración de personal
Microsoft Office
Maestría
Licenciatura

Descripción completa del empleo

Key Responsibilities

Serve as Regulatory Team Lead on complex global studies, including oversight of technical writing and submission publishing.

Draft, review, and quality-check clinical trial regulatory core study documentation at global and country level .

Engage directly with clients to clarify clinical trial regulatory pathways, share lessons learned, and address feedback.

Engage with Competent Authorities in countries across multiple regions, as part of the clinical trial regulatory strategy for complex global studies

Monitor scope, deliverables, timelines, and budget; proactively mitigate risks and escalate issues as needed.

Provide guidance and feedback to junior colleagues; support training and continuous improvement initiatives.

Contribute to internal SOP reviews and present regulatory processes at full-service bid defenses.

Perform additional tasks assigned by Regulatory management to meet program goals.

Qualifications

Bachelor’s or Master’s degree in Life Sciences or related discipline.

3–4 years of relevant clinical trial regulatory experience within CRO or biotech/pharma.

Strong understanding of the R&D continuum (CMC, preclinical, clinical) and applicable laws, guidelines, and agency expectations for clinical trials.

Demonstrated expertise in at least one clinical trial regulatory domain (e.g., CMC, labeling).

Experience with clinical trial regulatory submission platforms and pathways, including but not limited to, EU CTR, Health Canada, US FDA IND submissions and/or systems in other regions such as LATAM or APAC. Biotech therapy area exposure welcomed.

Proficiency with Microsoft Office and regulatory publishing tools (e.g., eCTD systems); meticulous document management skills.

Excellent written and verbal communication, organization, and stakeholder-management abilities.

Proven ability to manage multiple projects; work in a fast-paced environment with competing priorities; and view obstacles as challenges to be handled with ease and grace; follow SOPs consistently, and exercise sound judgment on discrete tasks.

Problem-solving mindset with adaptability in fast-changing environments; self-motivated and collaborative.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.

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regulatory affairs empleos

Regulatory Affairs Officer, IQVIA Biotech

Regulatory Affairs Specialist I

Technical Services Analyst

Sr Associate - Consumer Digital Ecosystem

Diseñador Gráfico Freelance

Senior Clinical Data Engineer (LATAM)

Senior Clinical Data Engineer (LATAM)

Regulatory Affairs Specialist I

Patient Access Partner

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