Manager Regulatory Affairs

Cencora; São Paulo; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A healthcare consulting firm based in São Paulo is seeking a Regulatory Affairs Consultant to manage operational tasks within the Regulatory Strategy & Procedure Management area. Candidates should have 4-5 years of relevant experience, advanced knowledge in the field, and fluency in English and Portuguese. The role involves client interaction, regulatory processes, and project management. Benefits offered may vary based on local market practices.

Qualificações

• 4-5 years of experience in a similar role.
• Advanced English and Portuguese, Spanish is a plus.
• Strong practical knowledge of service area.

Responsabilidades

• Develop client relationships and explore service support opportunities.
• Participate in regulatory processes for marketing authorizations.
• Prepare and review regulatory documentation.
• Communicate with clients and health authorities.
• Plan and execute projects per KPIs.
• Provide consultancy in regulatory affairs.

Conhecimentos

Client relationship management

Regulatory processes knowledge

Project management

Communication skills

Problem-solving

Service orientation

Formação académica

University degree in Life Science or similar

Descrição da oferta de emprego

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

This role is in support of Cencora's global pharma consulting services marketed through our PharmaLex business

Summary

Accountability for the execution of operational tasks in the Regulatory Strategy & Procedure Management Practice Area that requires established experience and specific scientific expertise in the sector of human and veterinary medicinal products.

Responsibilities

• 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.

Requirements

• 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.

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies

Affiliated Companies : PharmaLex GmbH