Associate Director UK&IE Regulatory Affairs

Together, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of innovative & generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.

• 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 that cross-functional activities to 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.   
• Provide regulatory support throughout 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 of RA documentation, policies and procedures to 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

We support our people through every stage of their journey with us. Our flexible reward platform puts you in control, empowering you to tailor your benefits to fit your lifestyle, priorities, and what matters most to you. With 25 days of annual leave that grows with your service, the flexibility to purchase additional days, and two dedicated volunteering days each year, your time off is truly yours to enjoy, recharge, and give back. We prioritise your health with private medical insurance, life assurance, critical illness cover, and income protection.

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

To help you grow with confidence, we offer a structured training and development programme tailored 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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Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.#TJ