Contribuyo a la investigación clínica con experiencia y empatía. Y lo hago
Senior Regulatory Affairs Associate
Primary Location: Brazil, Remote ID de la oferta R0000037324 Categoría Regulatory Affairs Fecha de publicación 12/19/2025Overview
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
The Senior Regulatory Associate will author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including responses to Health Authority requests. Responsibilities include preparing and reviewing CMC packages, supporting GMP submissions, managing change control assessments, and ensuring compliance with regulatory requirements across multiple regions. The role requires strong technical regulatory expertise, excellent writing skills, and the ability to evaluate scientific CMC information for accuracy. A degree in biological or health sciences (Regulatory Affairs preferred) and at least 5 years of experience in CMC regulatory affairs within the biotech or pharmaceutical industry are essential.
Activities:
Author global CMC variation submissions (m1/2/3), including responses to HA requests.
Author CMC components for annual reports and renewals (m1/2/3), including responses to HA requests.
Author CMC components for global MAA (m1/2/3) rollouts (post 1st wave approvals), including responses to HA requests.
Author CMC components for tender applications (m1/2/3).
Support CMC GMP submissions, e.g., site registrations.
Change control assessments (Client to assess major impact countries, vendor to assess impact for all other countries).
Confirm CMC requirements for submission e.g. variation, renewal, tender, etc.
Align with the client (information flow to be defined) on technical information to be provided and timelines.
Preparation of the CMC packages.
Provide packages for internal client review and update these as needed.
Provide finalized packages for publishing and QC published output.
Update of internal systems (RIMS, Publishing, eDMS) or documentation as needed.
Support requests for information from HAs or from affiliates/partners.
Complete change control assessments for non-major impact countries.
Education:
University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD).
Degree in Regulatory Affairs is advantageous, but not mandatory.
Experience:
Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs CMC.
Sound knowledge in natural sciences with a focus on biological/vaccines/small molecule medicinal products.
Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia).
Strong regulatory CMC writing skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements.
Knowledge in Good Manufacturing Practice or related areas would be highly regarded.
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Perspectivas de los empleados
POR QUÉ TRABAJAR EN PAREXEL
