Contribuyo a la investigación clínica con experiencia y empatía. Y lo hago
Regulatory Affairs Consultant - CMC author biologics (home or office based)
Primary Location: United Kingdom, Remote Additional Locations: Croatia, Remote; Croatia, Zagreb; Czech Republic, Prague; Czech Republic, Remote; Hungary, Budapest; Hungary, Remote; Lithuania, Remote; Lithuania, Vilnius; Poland, Remote; Poland, Warsaw; Romania, Bucharest; Romania, Remote; Serbia, Belgrade; Serbia, Remote ID de la oferta R0000045277 Categoría Regulatory / Consulting Fecha de publicación 10/09/2026
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
Parexel is seeking experienced CMC (Chemistry, Manufacturing, and Controls) professionals to join us as a Regulatory Affairs Consultant CMC Author to support our client. This position requires expertise in regulatory affairs, CMC authoring for initial submissions and lifecycle management, and other pharmaceutical documentation for biologics. Previous experience working with biologics products is a must.
The role can be home or office based in various European locations.
Role Responsibilities:
- Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
- Thorough understanding of global regulations and ICH guidance pertaining to pharmaceutical development and lifecycle management of NCE/NME products.
- Experience preparing CMC sections of IND/IMPDs, BLA/NDA/MAAs, and supportive clinical amendments and post approval supplements/variations. (ICH Modules 2 and/or 3)
- Write scientific rationales to support regulatory answers, variations, and dossier submissions
- Coordinate CMC activities across multiple projects and manage timelines effectively
- Thorough understanding of change management processes and regulatory requirements.
- Build and assess regulatory strategies for variations and registrations based on affiliate information and EU/US guidelines
- Develop regulatory strategy for medical devices part of combination products
- Update and maintain database with current regulatory information
- Provide ad-hoc CMC consulting support and technical advice
Required Qualifications & Skills:
- University degree in Chemistry, Pharmacy, Chemical Engineering, or related pharmaceutical field
- 10+ years of pharmaceutical industry experience in CMC and regulatory affairs
- Strong expertise in CMC for biologicals – initial submissions and Lifecycle maintenance
- Comprehensive understanding of ICH guidelines and EU/US regulatory guidelines
- Strong problem solving and diplomacy skills
- Ability to manage multiple projects simultaneously and meet deadlines
- Experience with Veeva or similar document management systems
- Fluent English (written and spoken); Additional European languages (French, German, Spanish) are advantageous
#LI-REMOTE
Perspectivas de los empleados
POR QUÉ TRABAJAR EN PAREXEL
