Teva
Pharmaceuticals Regulatory Affairs Associate I B. Pharm/M. Pharm/ Master of
Life Sciences
Job
Description
Publish
and dispatch major and complex routine/lifecycle management eCTD submission
projects for EU, US and Canada.
Exposure
in handling initial submissions publishing and transmitting quality submissions
to agency.
Perform
document level publishing activities, troubleshoot document issues and perform
quality control checks for submission ready documents as per the agency
guidance.
Collaborate
with scientific personnel for planning, preparation, publishing and quality
control checks of submissions.
Hands
on expertise in EU and US submissions from pre-approval to post approval
activities like initial, variations, PSUR etc.
Participate
in Global Regulatory Affairs project teams
Maintain
working knowledge of internal and external publishing standards.
Knowledge
of ICH and eCTD related specification/guidelines governing regulatory
submissions (eCTD, NeeS, paper)
Must
be aware of Technical systems like Global Insight, ISI Toolbox, Adobe Acrobat,
Lorenz Validator
Sees
opportunities for creative problem solving while staying within the parameters
of good practice. Generates unique but workable and useful solutions to
difficult problems
Qualifications
B.
Pharm/M. Pharm/ Master of Life Sciences – M Pharm preferred
Experience:
Total
years of experience required for the role:
1-2 years (preferred - Regulatory Publishing experience in EU and US
market)
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