GlaxoSmith
Regulatory Specialist MSR Coordination Senior
Key
Responsibilities:
Minimum
5 years of experience in CMC variation in all the markets
Expertise
in CMC Authoring of Variation dossier (focus on Module 3 components authoring)
Experience
in authoring variation of Vaccines (preferable) , we can consider for Pharma
also
CMC
Variation experience for – EU and ROW / International markets
Knowledge
on Vaccines
With
minimal input from manager executes agreed dossier strategy
manages
multiple project assignments (e.g., Variations <CMC & Therapeutic>,
Product Expansion dossiers, Renewals, MSRs <CMC&non-CMC>)
simultaneously; dossiers will range in complexity
completes
data assessment to ensure dossier is fit for purpose.
identifies
risks associated with submission data and information packages.
Communicates
with line manager to identify issues that have business impact.
May
have dossier review responsibilities for peers and may identify improvement
opportunities for Regulatory processes, policies and systems.
Developing
an understanding of regulations, guidelines, procedures and policies relating
to registration and manufacturing of pharmaceutical products, to expedite
submission, review and approval of global regulatory applications.
Understands
internal/external Regulatory environment.
Actively
builds an organizational network.
Communicates
across GSK, with minimal input from manager regarding project and policy issues
ensuring optimum position for GSK.
Our
goal is to be one of the world’s most innovative, best performing and trusted
healthcare companies. We believe that we all bring something unique to GSK and
when we combine our knowledge, experiences and styles together, the impact is
incredible. Come join our adventure at GSK where you will be inspired to do
your best work for our patients and consumers. A place where you can be you,
feel good and keep growing.
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