Associate Director UK&IE Regulatory Affairs
Join to apply for the Associate Director UK&IE Regulatory Affairs role at Teva Pharmaceuticals
Who We Are
Teva Pharmaceuticals is a leading manufacturer of innovative and generic medicines. We are on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives.
The Opportunity
* Develop the regulatory strategy, preparation, and execution of regulatory submissions for Teva's innovative products.
* Represent Innovative Medicines Regulatory Affairs in local and global teams and provide regulatory filing strategy and guidance.
* Oversee and take ownership of Regulatory activities and strategies for Innovative medicines projects.
* Prepare and submit new UK and IE Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar, and OTC products.
* Ensure high-quality data and standards are used in support of all regulatory applications.
* Dossier Risk Assessment (Due Diligence).
* Work proactively with internal and external stakeholders to ensure work is prioritized in accordance with business needs.
* Assess business development opportunities from a regulatory perspective.
* Mentor and train other regulatory professionals as required.
Your Experience And Qualifications
* BSc/MSc in pharmacy, chemistry, or Life Sciences.
* A strong understanding and knowledge of local regulatory requirements, and actual experience of leading regulatory activities in the United Kingdom.
* Substantial regulatory new submission and post-approval submissions experience for a wide range of dosage forms and legal basis.
* 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.
* Good leadership, project management, and communication skills, as well as managerial capability, with excellent attention to detail.
What We Offer
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.
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.
#J-18808-Ljbffr