Contribuyo a la investigación clínica con experiencia y empatía. Y lo hago
Regulatory Affairs Consultant - on-site in Basel (German and French language skills)
Primary Location: Switzerland, Basel ID de la oferta R0000046397 Categoría Regulatory / Consulting Fecha de publicación 09/30/2026
Overview
Como parte de Consultoría de Parexel, cumplirá un rol vital al asistir a las empresas biofarmacéuticas y de dispositivos médicos a transitar el complejo y siempre cambiante entorno regulatorio. Respaldado por su experiencia científica, técnica y regulatoria, trabajará de cerca con los clientes para desarrollar e implementar estrategias regulatorias que colocarán sus medicamentos en el mercado con mayor rapidez y los mantendrán allí.
Valoramos la colaboración, la innovación y el aprendizaje continuo. Como miembro de nuestro equipo, se asociará con un grupo diverso de clientes y estará expuesto a diversos tipos de medicamentos y áreas terapéuticas. Asimismo, desarrollará sus habilidades a través de asignaciones desafiantes y con la mentoría de profesionales experimentados en asuntos regulatorios. Además, disfrutará de la flexibilidad de trabajar en modalidad remota, al tiempo que forma parte de un equipo colaborador y dinámico.
Perfil del éxito
¿Posee estas competencias sociales y rasgos interpersonales para tener éxito en Parexel?
- Comunicador
- Estratégico
- Constructor de relaciones
- Solucionador de problemas
- Orientado al detalle
- Impulsado por los resultados
Acerca de este rol
We are seeking an experienced Regulatory Affairs Consultant to join our global Regulatory Affairs team. In this role, you will develop, review, and manage regulatory submissions and compliance activities for pharmaceutical products throughout their lifecycle—from clinical development through post-market activities. You will work collaboratively with cross-functional teams while demonstrating strong independent judgment and operational expertise.
This is a client dedicated role and you will be working from an office 2 days a week (Basel).
Key Responsibilities:
Develop, contribute to, and review content and format for regulatory submissions according to Swiss regulatory guidelines, including:
- Major and minor submissions
- Periodic Safety Update Reports (PSURs)
- Label changes and Chemistry, Manufacturing & Controls (CMC) variations
- Post-approval commitments, variations, and notifications
- Collaborate with the Swiss regulatory team, Global Regulatory Science, Regulatory CMC, and cross-functional project teams to develop and execute regulatory strategy throughout the product lifecycle, including clinical development, post-market activity, and life cycle management.
- Coordinate regulatory submission aspects relevant to assigned projects and programs.
- Maintain Swiss labeling (SmPC, PIL, artwork, and packaging in local languages) in alignment with regulatory requirements and global labeling/core datasheet standards.
- Demonstrate strong ability to work both independently and collaboratively within project teams to achieve group goals.
- Support the Head of Regulatory Affairs Switzerland in regulatory activities as appropriate.
Skills and Qualifications:
- University Degree in Life Sciences or related discipline
- 5-8+ years of professional experience in Regulatory Affairs (Marketing Authorization Applications and post-approval variations)
- Strong, current knowledge of Swissmedic regulations (mandatory)
- Proven experience in preparing major regulatory submissions and variation packages to Swissmedic
- Strong experience with CTD format and eCTD submission builds
- Experience in biologics and vaccines development - preferred
- Knowledge of Rare Diseases, Autoimmune Diseases, or Oncology therapeutic areas - preffered
- Fluent spoken and written German, French and English
Perspectivas de los empleados
POR QUÉ TRABAJAR EN PAREXEL
