Regulatory
Affairs Associate I @ Teva Pharmaceuticals Degree in science/life sciences/Pharmacy
or equivalent Apply Now
Company
Info
Teva
is a global pharmaceutical leader and the world's largest generic medicines
producer, committed to improving health and increasing access to quality health
solutions worldwide. Our employees are at the core of our success, with
colleagues in over 80 countries delivering the world's largest medicine cabinet
to 200 million people every day. We offer a uniquely diverse portfolio of
products and solutions for patients and we've built a promising pipeline
centered around our core therapeutic areas.
We are continually developing patient-centric solutions and
significantly growing both our generic and specialty medicines business through
investment in research and development, marketing, business development and
innovation. This is how we improve health and enable people to live better,
healthier lives. Join us on our journey of growth!
Job
Description
Prepare,
compile, review and submit high quality submissions for all required
post-approval activities in accordance with EU legislation and in-house
standards.
Ensure
approvals are secured within the stipulated timelines and maintain
registration.
Documentation
and associated electronic databases, in line with in-house procedures.
Provide
regulatory support and product information for all internal and external
customers, stakeholders and TEVA project teams.
Priorities,
plan and monitor submissions for allocated procedures while documenting and
informing involved parties of progress.
Communicate
with other Teva departments across Europe and European Agencies regarding
proposed and pending submissions.
Maintain
and develop awareness of current/pending regulatory legislation and guidelines.
Fulfilling
other allocated department duties and ad-hoc needs at the direction of Senior
Regulatory Affairs personnel.
To
complete the assigned tasks for new MA approvals and post-approval activities
in accordance with the Work Instructions to achieve regulatory compliance.
Ensure
task completion within the stipulated timelines for designated projects.
Provide
regulatory support for EU and Growth markets.
Qualifications
Degree
in science/life sciences/pharmacy or equivalent qualification(s).
Experience:
3-4
years experience in the Pharmaceutical Industry, ideally within Regulatory
Affairs but R&D, Development or QA would be considered.
Desirable
to have experience with preparation and submission of variations within Europe
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