Regulatory Affairs Consultant - Global Asset Lead (home or office based in various European locations)
Bucharest, Romania Additional Locations Czech Republic-Prague; Czech Republic-Remote; Hungary-Budapest; Hungary-Remote; Poland-Remote; Poland-Warsaw-Business Garden; Romania-Remote; Serbia-Belgrade; Serbia-Remote ID de la oferta R0000032008 Categoría Consulting Fecha de publicación 04/25/2025Overview
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 are seeking a highly skilled International Markets Regulatory Affairs Expert to join our dynamic team! We are looking for an experienced Regulatory Affairs professional with a broad understanding of regulatory science and requirements across international regions, particularly in emerging markets. The successful candidate will provide strategic guidance on regulatory submissions and lifecycle maintenance across international regions. If you are passionate about regulatory affairs and want to make a significant impact in the pharmaceutical industry, we encourage you to apply.
This role can be home or office based is selected European locations.
Key Responsibilities:
Develop International Regulatory Submission Strategies for a wide variety of products/projects
Support Project Leads in optimizing strategies for specific submissions in local markets
Guide delivery teams in creating International dossiers
Identify and mitigate risks related to international submissions
Conduct regulatory intelligence surveys and provide objective assessments
Represent the company at health authority meetings and document discussions and agreements
Coach, mentor, and lead regulatory teams to ensure timely and quality delivery of objectives
Monitor and advise on key changes in the regulatory environment of International markets
Qualifications:
University Degree in a Scientific or Technical Discipline
Several years of experience in pharmaceutical regulatory affairs, particularly in international markets
Broad background in pharmaceutical business and experience in various regulatory affairs areas (e.g., Global, European, International, Marketing Company, or health authority experience)
Strong project management skills
Excellent interpersonal and intercultural communication skills
Proficiency in local language and extensive working knowledge of English
Critical thinking and problem-solving skills
Perspectivas de los empleados
POR QUÉ TRABAJAR EN PAREXEL
