Contribuyo a la investigación clínica con experiencia y empatía. Y lo hago
CMC Regulatory Affairs Profesionals
Primary Location: Mexico, Remote Additional Locations: Argentina, Remote; Brazil, Remote ID de la oferta R0000037730 Categoría Regulatory Affairs Fecha de publicación 12/26/2025Overview
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
Join Our Growing Team of CMC Regulatory Professionals!
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:
- Conduct and deliver high quality, on time CMC regulatory activities, including compliant management of all internal tools and client systems;
- Author Administrative and CMC regulatory documents/deliverables and collaborate with project SMEs and client stakeholders to prepare submission packages;
- Full management of CMC submissions (i.e. planning, submission package compilation, RtQ preparation, Spontaneous HA queries, etc.);
- General submission coordination: Submissions planning (tracker update, timelines agreement with LRA and GRA-CMC, recurrent meetings with LRAs), create submission binders and Global Content List/Submission Content Plans, coordinate the publishing aspect, review of eCTD sequences;
- Act as main GRA point of contact for LRAs and other stakeholders (i.e. for responding to any queries)
- Excellent communication and stakeholder management skills;
- Strong organizational and time management skills;
- Strong problem-solving skills;
- Coordinate all assigned activities;
- Ensure compliance to all client SOPs/training sessions;
- Proactive’ and ‘efficient' work ethic; Strong oral skills, with proven ability to work efficiently as part of a team;
- Strong interpersonal skills.
Education:
University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD), a degree in Regulatory Affairs is advantageous.
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 writting 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.
This role offer exciting opportunities for growth and impact within a collaborative and forward-thinking team environment. Ideal candidates will be motivated by the chance to shape regulatory strategies, drive successful submissions, and ultimately contribute to bringing important medical advancements to patients worldwide.
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POR QUÉ TRABAJAR EN PAREXEL
