Dr. Reddy's
Laboratories Hiring Regulatory Affairs Analyst – API Apply Now M.Pharm / M Sc
Job Description:
Knowledge of
the regulatory guidance available with FDA, ICH, EMA, with expertise in ANVISA,
other regulatory agencies for APIs and fair understanding of the drug products
approval cycle.
Search &
review the regulatory assessment reports (RLD / SBOA/EPAR/other literature
evidences) available in regulatory websites or public domain and share the
inputs with HPT for fixing the limits for impurities or defining the control
strategy based on the maximum daily dosage.
Must have
sufficient chemistry knowledge to evaluate the synthetic schemes and aid in
selection of appropriate regulatory starting materials for these complex APIs
and define regulatory requirements for the selected starting materials in
consultation with their managers.
Participate
in the technical discussions with the HPT for defining & finalizing the
specifications for starting materials/intermediates/drug substance.
Ensure GTI
evaluation is carried out and necessary control strategies are put in place
based on purge study, purge factors and/or routine or non-routine testing of the
PGIs at appropriate stages.
Responsible
for communicating the global & region specific regulatory requirements to
HPT for a global development.
Review the
documents received from CFTs and ensure quality of the technical reports and
DMF.
Responsible
for responding to the regulatory deficiencies with adequate data and within
stipulated timeline.
Co-ordinate
with GMO teams Plant documentation needed for DMF preparation/deficiency
responses/customer support.
Stay
well-informed of the regulatory procedures and the changing regulatory
requirements. Must be aware of QbD principles, ICH guidelines to ensure their
applications during product development and preparation of DMF submissions.
Share the
learning from regulatory deficiencies and updated regulatory guidelines with
CFTs periodically during the daily meeting to integrate the requirements.
Provide
customer support by arranging technical packages, open part DMFs, and
addressing customer queries in timely manner.
Must have
basic computer knowledge eg.MS-office, Chem Draw, etc.
Maintain
records to comply with regulatory requirements. Update and maintain
paper/electronic document archival systems
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