Regulatory Affairs Senior Manager

Cencora; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A global health organization based in Spain is looking for a Senior Manager Regulatory Affairs to strengthen client relationships and drive regulatory processes for human and veterinary medicinal products. The ideal candidate will have a degree in Life Science, extensive experience in regulatory affairs, and excellent communication skills in English and Spanish. This remote role allows you to lead teams and ensure compliance with regulatory standards while supporting business development activities.

Formación

• Proven in-depth professional experience in regulatory affairs.
• Ability to translate strategic goals into tactical milestones.
• Very good communication skills in English and Spanish.

Responsabilidades

• Develop and maintain client relationships.
• Participation in regulatory processes for marketing authorizations.
• Preparation and review of regulatory documents.
• Support scientific advice procedures.

Conocimientos

Project management

Analytical skills

Leadership

Communication

Regulatory knowledge

Strategic planning

Client relationship management

Educación

University degree in Life Science

Descripción del empleo

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

Pharmalex, a Cencora company, is looking for a Senior Manager Regulatory Affairs to join the team, remote based in Spain.

Key Responsibilities

• Develop and maintain strong client relationships and help drive opportunities for increased service support to Line Manager.
• 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.
• Ensure personal leadership in supporting VDC strategy implementation and optimization.
• Comply with, maintain and contribute to optimizing internal processes.
• Provide day to day operational support for colleagues.
• Support with VDC led commercial, marketing and business development activities including proposal input.
• Oversee project team to ensure delivery to budget and manage resolution of any invoicing queries.
• In agreement with 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 their Line Manager/Practice Area Lead/Head of VDC REG.
• Leadership and coaching of the direct reports; conduct of probation period, annual employee evaluation, personal development and goal setting meetings where applicable.
• Maintain oversight of direct reports utilization, capacities and capabilities and communicate to Team Lead. Escalation of issues to LM/HR accordingly.

Education & Experience

• University degree in Life Science.
• Proven in-depth professional experience in area of responsibility; extensive knowledge of discipline or department, solves complex problems, strong understanding of the business.

Minimum Skills, Knowledge & Ability requirements

• Ability to translate strategical goals of partnerships/customer or internal projects into tactical goals and implement concrete milestones; ability to define appropriate escalation process.
• Structured, analytical, systematic and independent way of working; wide discretion to take action consistent with operating policies; determine priorities.
• Lead extensive project reengineering activities and provide consultation related to change management. Proactively identify up/cross selling opportunities. Ensure that the team identifies, documents, and drives resolution for program issues.
• Demonstrable ability in leading, mentoring, managing and motivation of staff.
• Ability to lead project teams, distribute work equally and according to team member's strengths as well as to achieve commitment according project milestones.
• Ability to manage internal and external (client) relationships on level of client's department heads; ability to discuss and align mid-term goals of collaboration.
• Very good communication skills (written and verbally); proven capability to communicate critical issues and propose appropriate (cross-divisional) solutions to decision makers. Good presentation skills, confident appearance.
• English business fluent & Spanish

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.

Affiliated Companies

PharmaLex Spain S.L.U.