Novartis India Associate, DRC (Development Regulatory
Centers) Bachelors degree in Chemistry, Pharmacy, Biochemistry, Biotechnology,
Biology) or equivalent
Prepare query responses to health authority questions during
development and registration in close collaboration with relevant SDC
departments. Identify and escalate as appropriate content, quality and/or
issues with source documents, or any other potential authorizing issues that
may impact submission quality or timelines, as early as possible.
• Keep knowledge up to date with regard to regulatory
guidelines and requirements in all global regions as well as for new technical
trends. Active participation as a member of development team by contributing to
the regulatory strategy, identifying critical issues and applying lessons
learned.
• Establish and maintain sound working relationship with all
Sandoz Regulatory affairs departments and as well SDC teams. Interact with
cross-functional teams in SDC, India for assigned development projects and
prepare timely query responses, as appropriate.
• Support to DRC Manager/Specialist for global regulatory
strategy for developments projects with a focus on creativity and innovation,
maximizing the business benefit balanced with regulatory compliance. Assume
specialized assignments as assigned and represent own departments in
cross-functional project teams.
• Other tasks as assigned by the supervisor, and tasks based
on a specific appointment. Other tasks determined during the annual objectives
setting process and by KPIs. Implementation of and compliance with all the
instructions and requirements for safety at work, environment protection, and
property protection
Minimum – Degree in Science (e.g. Bachelors degree in
Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
Desired – Advanced Degree in Science (Bachelors/Masters/Ph.D. in Chemistry
• Regulatory experience mandatory (minimum of 3 years),
and/or experience in pharmaceutical industry in US, EU, Most of world market
etc. Solid knowledge of ICH, EMA, US FDA guidelines and regulatory procedures.
• Working knowledge of chemistry, analytics or pharmaceutical
technology. Knowledge of the drug development of process desirable. Ability to
critically evaluate data from a broad range of science disciplines.
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