Senior Regulatory Affairs Manager (d/f/m)

The Senior Regulatory Affairs Manager (m / f / d) will be the regulatory representative for assigned projects, programmes and processes, responsible for securing stakeholder alignment.

The tasks and responsibilities include :

• Leading regulatory affairs activities for assigned projects and programs and for leading affiliate RA to identify and complete the respective national regulatory requirements so as to support commercialisation. The task will include
• Oversight of regulatory vendors, including their activities on a day-to-day basis, ensuring successful execution of operational activities, tracking, and archiving for assigned products.

Deciding on activity prioritization for vendor

• Implementation of vendor oversight plans, including establishment and management of KPIs, and, tracking and monitoring of deviations, and reporting of metrics
• Leading the vendor(s) and driving identified innovative process change for improved efficiency
• Provide training and support to regulatory colleagues, in-country RA leads, and vendors as applicable, ensuring In-country RA leads training and access is maintained
• Management and oversight of regulatory contracts, SOWs, and PO's including renewal activities, working closely with procurement, finance and medical operations
• Planning and implementing defined regulatory strategies, and co-ordination and filing of all appropriate regulatory submissions for assigned projects and programs
• Oversight and management of regulatory in-country A&Ds, workload assignments & deliverables, prioritisation, and troubleshooting.

Working closely with affiliate and distributor teams to ensure successful execution of biosimilar regulatory responsibilities

Development of core aRMMs and for leading their customisation, submission, approval and dissemination across markets incl.

implementation of updates to approved aRMMs

In order to be considered for the role, you must have :

• 6 to 8+ years pharmaceutical / biotechnology industry with 4 to 6+ years regulatory experience
• SME in regulatory processes
• Good knowledge of applicable regulations, and submission standards / requirements. Ability to interpret regulations and guidelines
• Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements
• Strong communication and project management abilities in global and virtual teams
• Strong interpersonal skills and the ability to collaborate effectively across project teams and external stakeholders
• Ability to work independently with minimal supervision
• Strong organisational skills to prioritize personal workload and to manage a large volume of complex tasks and attention to detail

The selected candidate will have a direct impact on the company s success in Europe and contribute to the optimisation of internal RA structures and activities.

Hybrid working model (3 home-office days).