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 team. As a Regulatory Affairs Consultant, you will be responsible for providing expertise in registration Regulatory Affairs, with a focus on Global Regulatory (Clinical/Safety) and Global Labelling. This role will require the successful candidate to complete variations and renewals applications at the country level (Belgium, Netherlands, and Luxembourg).
Job Responsibilities
Utilize your previous experience in registration Regulatory Affairs to support Global Regulatory (Clinical / Safety) and Global Labeling processes.
Complete variations and renewals applications for Belgium, Netherlands, and Luxembourg.
Demonstrate knowledge of EU and country-specific regulations and be familiar with document management systems.
Understand the Regulatory processes required to update labelling of a product, including different variation categories.
Utilize familiarity with the Company Core Datasheet (CCDS) and its implementation into labelling and artworks.
Be knowledgeable about the triggers that lead to a CCDS update.
Demonstrate some understanding of Periodic Safety Update Reports (PSUR) and their potential impact on labelling.
Appreciate the relationship between labelling and artwork processes.
Have knowledge of SmPC, PIL, and QRD requirements and EU linguistic review.
Possess some understanding of EU readability and PIL (testing).
Knowledge and experience required for the role:
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline
A few years of experience in a CRO/Pharma
A few years of relevant experience in submissions of variations and review of the labels and notices. 3-5 years in registration Regulatory Affairs to support Global Regulatory (Clinical / Safety) and Global Labeling processes.
Client-focused approach to work
Excellent interpersonal and intercultural communication skills, both written and verbal
Critical thinking and problem-solving skills
Proficiency in English, Dutch, French. German would be a plus.
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