Senior Regulatory Affairs Associate-Biologics
Bengaluru, India ID de la oferta R0000024721 Categoría Regulatory / Consulting Fecha de publicación 11/28/2024Overview
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
Senior Regulatory Affairs Associate
- Around 4-8 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets.
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
- Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
- Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
- Experience in handling CMC related health authority queries
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
- Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products (Orals & Parenterals) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
- Preparation of documentation for different types of Variation procedures like Super grouping,
- Grouping and Work-sharing to the Marketing Authorizations.
- Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements.
- Providing regulatory impact assessment for change proposals and identification of required documentation for EU submissions
- Liaise closely with cross-functional members with aligned product responsibilities.
- Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates.
- Working experience in Regulatory Information Management Systems like Veeva Vault.
- Strong communications skills and ability to guide and mentor team members.
Ability to work independently.
Perspectivas de los empleados
POR QUÉ TRABAJAR EN PAREXEL
