Teva Associate Director UK & IE Regulatory Affairs 

United Kingdom, England 

364576630

• Responsible for developing the regulatory strategy, preparation and execution of regulatory submissions for Teva's innovative products
• Represent Innovative Medicines Regulatory Affairs in local and global teams (Global Regulatory Strategy Team (GRST), project team, portfolio/commercial team, etc.) and provide regulatory filing strategy and guidance
• Oversee and take ownership for Regulatory activities and strategies for Innovative medicines projects
• Preparation and submission of new UK and IE Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products
• To ensure high quality data and standards are used in support of all regulatory applications
• Dossier Risk Assessment (Due Diligence)
• To work proactively with internal and external stakeholders (e.g. MHRA and HPRA) to ensure work is prioritise in accordance with business needs
• Assessment of business development opportunities from regulatory perspective.
• Mentoring and training of other regulatory professionals as required

• Portfolio of products:Responsibility of UK/IE assigned Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products.
• Ensure thatcross-functional activitiesto support submissions are in compliance with regulatory requirements, to achieve timely submissions. Identify gaps and propose/support solutions to address them that are consistent with regulatory requirements. Initiation and/or participation in teleconferences and/or meetings related to the topic/project (to clarify issues, solve issues, discuss changes and strategy, check timelines and availability of documents, etc.).
• Regulatory support to R&D:Ensure R&D receive the regulatory guidance necessary to ensure that responses are submitted on time and that content is aligned with MHRA/HPRA data requirements.
• Provideregulatory supportthroughout product development to approval for local co-development initiatives and local in-license of new products
• Strategy:Formulate regulatory strategies for products within the team for new submissions and post approval changes. Actively participate in gross-functional teams and contribute to Teva’s overall strategy through identification, development and implementation of business improvement initiatives.
• Oversee the development and maintenance ofRA documentation, policies and proceduresto implement local regulatory policies and procedures to assure compliance with Teva operating principles, SOP’s and other in house requirements.
• Stakeholder management: Build strong working relationships with key interfaces and provide regulatory support for interfaces where requested. Promote cross-functional working across the PV, medical, commercial, quality and supply chain teams.
• Marketing Authorisation Applications: Deliver new submission work plan commitments for all allocated products. Ensure that regulatory approvals are secured in a timely manner for on-time launches.
• Post Approval support: Ensure that regulatory post approval regulatory obligations are fulfilled to ensure compliance, deliver on time launches and maintain continuity of supply.
• External interactions: Lead or participate in preparations for health authority meetings and effectively chair discussions. Where requested, contribute to industry association projects and participate in regulatory professional body activities on request.
• Regulatory Intelligence: Maintain an in-depth understanding of legislative requirements, MHRA regulatory guidance and changes to the external environment that could affect the UK/IE market.
• Other:Other duties as required by the direction of the Director of Regulatory Affairs regarding project leadership/management, strategic planning, business process redesign and commercial implementation.

Do you have...?

• BSc/MSc in pharmacy, chemistry or Life Sciences
• A strong understanding and knowledge of local regulatory requirements, and also actual experience of leading regulatory activities in the United Kingdom (e.g. scientific advice, MAA submissions to MHRA, NICE technology appraisal)
• Substantial regulatory new submission and post approval submissions experience for a wide range of dosage forms and legal basis, especially for new chemical entities, but also generics, devices and OTC products.
• Regulatory strategy development with a focus on bringing innovative solutions to project teams and health authorities.
• Demonstrated experience of contact and relationship with health authorities, preferably with MHRA and HPRA.
• A good knowledge and experience in CTAs, paediatric investigation plans and orphan designations.
• Experience in leading and chairing Scientific Advice meetings.
• Management or mentoring of team members including accountability for projects and regulatory strategy, ownership of team structure and line management of team members.
• Good leadership, project management and communication skills as well as managerial capability, with excellent attention to detail.

Are you...?

• Able to strategically apply knowledge across a portfolio of products
• Excellent oral and written communication skills
• Negotiator
• Analytical
• Good trainer who loves coaching
• Able to monitor and communicate change in the regulatory environment
• Able to work effectively in a global matrix

Whether you're growing your family or pursuing new adventures, ourenhanced maternity and paternity leave, sabbaticals, and hybrid working policiesare here to support you through life’s most meaningful moments. Financial wellbeing matters too, which is why we offer anenhanced pension scheme, access to a discount store, and free financial coaching through Bippit.

To help you grow with confidence, we offer a structuredtraining and development programmetailored to your role and department, equipping you with the tools, knowledge, and support you need to thrive.

Director Regulatory Affairs UK&IE

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