Associate Director¸ Regulatory Affairs UK & Ireland

Harlow, England, gb
Company: Tevapharm
Category: Management Occupations
Published on 2021-06-20 18:02:59

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 looking for an Associate Director to join our UK & Ireland Regulatory Affairs team to be responsible for all new UK & Ireland Marketing Authorisation submissions for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products.

A Day in the Life of...

  • You will be responsible for a large portfolio of products regarding Marketing Authorisation applications for new Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products.
  • You will ensure that R&D receive the necessary regulatory guidance so that responses are submitted on time and are aligned with MHRA/HRPA data requirements.
  • 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 Regulatory Affairs documentation, policies and procedures.
  • You will ensure that regulatory post approval obligations are fulfilled to ensure compliance, deliver on time launches and maintain continuity of supply.
  • You will manage a team of around 6 people, providing effective leadership and clear direction to our stakeholders, ensuring that the team and structure meet the evolving needs of Teva UK & Ireland.
  • Who we are looking for

    Are you….

  • Able to work well under pressure and to tight deadlines?
  • A strong negotiator with the ability to influence with high levels of both written and verbal communication?
  • Used to training and coaching a team to allow them to develop?
  • Able to monitor and communicate change in the regulatory environment?
  • Do you have….

  • A Pharmacy / Chemistry / Life Sciences Degree or equivalent experience within Regulatory Affairs?
  • Experience managing a team including accountability for projects and regulatory strategy, ownership of team structure and line management of team members?
  • Experience contacting and maintaining a relationship with the MHRA and HPRA?
  • A working knowledge and experience in CTAs, paediatric investigation plans and orphan designations as well as leading and chairing Scientific Advice meetings?
  • Substantial regulatory new submission and post approval submissions experience for a wide range of dosage forms?
  • What do we offer you?

  • 25 days annual leave plus Bank Holidays
  • Company bonus scheme
  • Flexible benefits including health insurance, gymflex and cycle to work scheme
  • Programme of Wellbeing initiatives including on-site Creative Rooms, Employee Assistance Programme, Wellbeing Champions
  • Function

    Regulatory Affairs

    Sub Function

    Medical Regulatory Affairs

    Already Working @TEVA?

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    Teva’s Equal Employment Opportunity Commitment

    At Teva, we pride ourselves on being a company where we can all thrive, and where everyone feels comfortable being their true self.

    Diversity and inclusion sits at the heart of everything we do. By valuing difference, we can be a better employer for our colleagues, and provide a better service for our customers and patients. That’s why we’re constantly looking for ways in which we can learn from each other, embrace what makes us unique and contribute to a fairer society free from discrimination and prejudice.

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