Manager Regulatory Affairs

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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 :

Education :

University degree in Life Science or similar.

Skills and Knowledge :

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