Manager regulatory affairs – São Paulo/SP e Brasília/DF

Responsibilidades

• Develop and maintain strong client relationships and actively explore opportunities for increased service support to Local Affiliate Services.
• Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products.
• Preparation, review and compilation of documents within the framework of regulatory affairs projects.
• Communication with clients and Health Authorities.
• Support with scientific advice procedures and representation of clients with health authorities.
• Responsible for the planning and execution of client projects in accordance with KPIs. Coordination of project teams with colleagues and qualified external partners.
• General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management.
• Regulatory intelligence – develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues.
• Present seminars and lectures for colleagues, clients and professional audiences. Active contribution and distribution of department relevant expertise.
• Support with VDC strategy implementation and optimization.
• Comply with, maintain and contribute to optimizing internal processes.
• Support with VDC led commercial, marketing and business development activities including proposal input.
• Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries.
• In agreement with PharmaLex contact persons, e.g. Head of VDC REG providing on-site regulatory support to GCS clients.
• The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with the Service Line Lead Local Affiliate Services/Practice Area Lead/Head of VDC REG.

Requisitos

• Proven experience, or demonstrable capability, in area of responsibility or similar field at least 4 – 5 years in similar role.
• Advanced knowledge and insights required to perform complex tasks.
• Strong practical knowledge of service area and how it impacts the related areas.
• Advanced English and Portuguese. Spanish desired.
• Education:
  • University degree in Life Science or similar.
• Skills and Knowledge:
  • Ability to implement tactical goals of customer or internal projects within daily work.
  • Ability to prioritize parallel tasks, identify potential road blocks and initiate appropriate counter measures.
  • Structured, analytical, systematic and independent way of working; some discretion to take action consistent with operating policies, determines own priorities.
  • Ability to analyze and solve problems and to develop pragmatic solutions for a given task or project.
  • High service orientation.
  • Ability to train and support junior/new PharmaLex members in daily activities; ability to lead small project with clearly defined scope.
  • Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client’s team lead level.
  • Good communication skills (written and verbally); capability to communicate issues and propose appropriate solutions to decision makers. Good presentation skills and confident appearance.

Marcado como: Assuntos Regulatórios, Indústria Farmacêutica