Regulatory Specialist/Executive

4 weeks ago

Cambridge Cambridgeshire, United Kingdom AstraZeneca UK Full time

Join a place built on innovation and creativity. Where different views and perspectives are welcomed and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve.
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development.

QUALIFICATIONS
  • University degree from reputable universities (Preferably from Pharmacy, Chemistry, Chemical Engineering, Biology departments)
  • Advanced command of written and spoken English,
  • Preferably regulatory work experience in a pharmaceutical company:
    • Min 1 year of Regulatory Affairs experience for Specialist position
    • Min 4 years of Regulatory Affairs experience for Executive position
  • Advanced knowledge in MS Office applications,
  • High interpersonal, communication and presentation skills,
  • Good at teamwork,
  • Good at follow-up and strong planning skills,
  • No restriction for travel,
  • No military obligation for male candidates.
JOB DESCRIPTION
  • Preparation of registration and variation files according to current Ministry of Health requirements,
  • Approval of registrations and sales Permissions,
  • Preparation of SmPC/PIL submissions,
  • Manage the written correspondence with Ministry of Health before and after registration approval,
  • Follow up global and local regulatory requirements,
  • Maintain and update global and local regulatory systems.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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