Regulatory Affairs Manager, Global Regulatory Affairs Pharmaceuticals, EU
il y a 4 semaines
At Elanco (NYSE: ELAN) – it all starts with animals
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today
Position Description:
This role contributes to the regional registration activities for new and existing products by planning, coordinating, and delivering registration documentation to the regulatory agencies for assigned portfolio of products registered in two or more EEA countries (or the UK).
The individual in this role is expected to work as a partner to support R&D, the EEA and UK affiliates and the line management to meet critical registration timelines in compliance with global regulatory standards and guidelines.
Functions, Duties, Tasks:
Key Leadership Responsibilities
Support submission preparation in execution of regulatory strategies for new and existing products to provide high quality submissions, reducing questions / hearings leading to optimal review times and speed to market.Understand and evaluate a proposed product concept to provide the best possible product for the customer.Collaborate with Marketing, R&D and any other relevant teams to develop and maintain product labelling text. Proactively search for solutions.Work effectively and flexibly within and across all Elanco teams and external collaborators to achieve overall Elanco deliverables.Complete new and existing registrations to gain regulatory clearance for the import, manufacture, and/or use of new and existing science and products to enable business growth.Proactively monitor, evaluate business impact, and communicate new and amended legislation and regulations.Create a positive work environment that is aligned with company objectives.Provide information to facilitate accurate and timely project and budget forecasts.Manage project timeline and budget deliverables, as needed.Support the preparation and execution of project meetings (pre and post approval) with regulatory authorities as well as other external partners/customers.In collaboration with Regulatory Policy and Intelligence group, participate and/or provide input in industry associations to influence adoption of best practices in animal health regulatory advocacy programs critical to Elanco business success.Key Technical Responsibilities
Deliver high quality and approvable technical submission packages to the competent authorities for EU regional procedures.Support the EU regulatory teams to ensure product compliance in EU markets.Engage with EU affiliate managers to complete national requirements for EU procedures, including translations and fee payment for inclusion in the submission package.Coordinate the publication of dossiers for submission.Contribution to on-time fulfillment of competent authorities post approval commitments.Understand the technical aspects and science of the products on the market in EU.Global and local regulatory support in coordination with line management, as appropriate.Manage submission planning, preparation and tracking of EU/GB regulatory procedures for innovation and established products in Vault RIM.Prioritize submissions where resource constraints require, in collaboration with supervisor and other functions.Maintain a positive business collaboration and partnership with regulatory authorities; Act as a point of contact for EU regulatory authorities, engaging with country/cluster Regulatory leaders on questions and responses.Participate in / contribute towards improvements in processes and procedures to deliver regulatory excellence in the new product development space as well as participate in post approval strategy and delivery globally. Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the employee has the necessary experience and/or training.Key Performance Indicators
Compliance with regulatory and company requirements.No interruption to product supply for regulatory reasons.Maintenance of existing marketing authorizations.Participate in creating a positive and motivating culture, with a "Play to Win" mentality.Successful cooperation and communication across countries and functions.Effective monitoring of the regulatory/competitive environment.Good relationship with colleagues in the teams at the hubs and affiliates.Minimum Qualification (education, experience and/or training, required certifications):
Education:
Bachelor’s degree in science related field or equivalent experience.Experience:
Demonstrated knowledge of EU regulatory processes – dossier preparation, submission and monitoring of post approval commitments.Additional Preferences:
Language Requirements: English. Any other language from EU region is an advantage.Other Information:
Limited Travel RequiredAny location in Europe with Elanco offices considered.-
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