Labeling Strategist

As a key member of our team, you will be responsible for Pre-evaluation of Reference Country Strategies, Deviation creation, Pre-evaluation of DLs, CCDS Update process till Global Dispatch, Binder creation, Attending Product PET meetings, Literature search, GLS QA check for Labeling Deviations Dashboard, Internal GLM meetings, Labeling Support, Pre-Evaluation of Prior Submission Deviations, Internal QA Check of Global Labeling documents, Drafting of Global Response Documents, Drafting of PET Meeting Minutes and PET Written Reviews, Email Archiving activities.

• Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
• 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.
• Support with preparation, review and compilation of documents within the framework of regulatory affairs projects.
• Communicate with clients and Health Authorities in close cooperation with the respective lead.
• Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead.
• 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.
• Support with VDC strategy implementation and optimization.
• Comply with and support the maintenance of internal procedures.
• Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead.

To be successful in this role, you should have:

• 3-5 years of experience or demonstrable capability in area of responsibility or similar field.
• Advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks.
• University degree in Life Science.
• Ability to deliver on customer or internal projects processes within daily work.
• Ability to prioritize parallel tasks escalate issues where appropriate and to offer solutions for appropriate counter measures.
• Structured and systematic and independent way of working limited latitude within established set of procedures may determine priorities with little supervision.
• Ability to analyze and solve problems and to offer solutions for a given task or project.
• Attention to detail High service orientation.
• Ability to train and support junior new colleagues in daily activities ability to lead small projects 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 solutions Confident appearance.

We are committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.

Reasonable accommodations will be provided to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation please call or email.