Tevapharm United Kingdom United Kingdom
1 month ago
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Date: Jul 23, 2023
Harlow, United Kingdom, CM20 2FB
Job Id: 47660
Who are we?
We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. Yet until today, you may not have heard of us.
We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world.
We are recruiting for an Associate Director, Regulatory Affairs UK&IE to have the ownership for all new UK (UK/GB/NI) and IE Marketing Authorisation submissions for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products, including support of all new product launch activities for both UK and IE.
Location: Harlow (Essex). Do you know that our Harlow office is the Centre of Excellence (CoE) for Regulatory Affairs within Teva , with teams covering both European and global licensing for medicines and... over-the-counter (OTC) products? The site is conveniently located half an hour commute from central London. To learn more about Teva UK, follow this link:
A Day in the Life of an Associate Director, Regulatory Affairs UK&IE...
• You will lead a team, having direct reports. You will provide a clear direction to our stakeholders, ensuring that the team and structure meet evolving needs to Teva UK/Teva Ireland
• You will have responsibility of all UK/IE assigned Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products
• You will 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
• You will provide regulatory support throughout product development to approval for local co-development initiatives and local in-license of new products
• You will formulate regulatory strategies for all products within the team for new submissions and post approval changes
• You will oversee the development and maintenance of RA documentation, policies and procedures
• You will deliver new submission work plan commitments for all allocated products, ensuring that regulatory approvals are secured in a timely manner for on-time launches
• You will ensure that regulatory post approval obligations are fulfilled to ensure compliance, deliver on time launches and maintain continuity of supply
• You will lead or participate in preparations for health authority meetings and effectively chair discussions
Who we are looking for
Do you have...?
• Pharmacy/Chemistry or Life Sciences degree
• Experience in regulatory affairs in pharmaceuticals and previous experience of managing teams (MUST HAVE)
• Demonstrated experience of contact and relationship with MHRA and HPRA
• Substantial regulatory new submission and post approval submissions experience for a wide range of dosage forms including generics, new chemical entities, devices and OTC products
• Experience in leading and chairing Scientific Advice meetings
• Detailed knowledge of CMC supporting data requirements for new Marketing Authorisations for generic/hybrid, OTC and new chemical entities
• A good understanding of the post Brexit MHRA requirements
Able to work under pressure and to tight time deadlines
Excellent oral and written communicator
Able to monitor and communicate change in the regulatory environment
Able to work effectively in a global matrix
What Teva can offer you
• Enjoying time with your families (25 days of annual leave, Hybrid approach to home working, Pension scheme, car or car allowance)
• Looking after your health (Life & Critical Illness Insurance, Private health insurance for you and your family, Sports and Health Programme – including health days and nutritional counselling, On-site Canteen)
• Recognizing your value (Recognition programs to reward our employees with our company bonus scheme)
• Well-being and D&I focused company
Director, UK&IE Regulatory Affairs
Teva's Equal Employment Opportunity Commitment
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. #TJ
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