Contribuyo a la investigación clínica con experiencia y empatía. Y lo hago
Senior Regulatory Affairs Strategist (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; Ireland, Dublin; Ireland, Remote; Italy, Milan; Italy, Remote; Lithuania, Remote; Lithuania, Vilnius; Poland, Remote; Poland, Warsaw; Romania, Bucharest; Romania, Remote; Serbia, Belgrade; Serbia, Remote; Spain, Madrid; Spain, Remote ID de la oferta R0000037501 Categoría Regulatory Affairs Fecha de publicación 12/17/2025Overview
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 an experienced Regulatory Affairs Professional to join our dynamic team as a Senior Regulatory Affairs Consultant. This strategic position requires a proactive and agile regulatory professional able to build strategy, drive execution, and address challenges involved in gaining market approvals across international regions. You will provide expert guidance to our clients and delivery teams while managing multiple projects in a fast-paced, results-oriented environment.
The role can be home or office based in various European locations.
Key Responsibilities:
Strategic Leadership
Develop comprehensive international regulatory submission strategies for a wide variety of products and projects including CTAs, MAAs and Lifecycle management.
Provide strategic guidance to clients and delivery teams on requirements and submissions across international regions
Support or act as Project Lead, working with local market Regulatory Affairs experts to optimize strategies for specific submissions
Submission Management
Guide delivery teams in the creation and maintenance of international dossiers
Drive and manage multiple regulatory submissions simultaneously
Ensure effective regulatory representation in partnership with appropriate technical experts at health authority meetings
Document discussions and agreements with regulatory authorities clearly and comprehensively
Regulatory Intelligence
Monitor and stay abreast of key changes in the regulatory environment of international markets
Create and perform regulatory intelligence surveys
Provide objective assessment of intelligence data
Communicate regulatory requirements and propose submission strategies to clients
Team Leadership
Coach, mentor and lead regulatory teams to ensure objectives are successfully delivered on time and with quality
Identify and mitigate risks with respect to international submissions
Guide cross-functional team discussions and drive regulatory solutions
Skills and Experience required for the role:
University degree in a relevant scientific discipline (e.g., Biomedical Sciences, Chemistry, Pharmaceutical Sciences)
10+ years of experience in the pharmaceutical/biotech industry, with substantial experience in Regulatory Affairs
Broad background in pharmaceutical business and experience in several areas within regulatory affairs (e.g., Global, European, International, Marketing Company or health authority experience)
Experience with biologics/vaccines/infectious diseases/oncology and rare diseases strongly preferred
Leadership in managing regulatory agency negotiations and organizing Scientific Advice Meetings with health authorities
Strong knowledge of CTD format and eCTD submission builds, including preparation of Modules 1-5 documents
Experience with Clinical Trial Applications and regulations relating to clinical trials
Strong influencing, negotiation, and relationship management skills
Advanced problem-solving skills and drive to generate compliant regulatory solutions
Fluent English, written and spoken
#LI-REMOTE
Perspectivas de los empleados
POR QUÉ TRABAJAR EN PAREXEL
