NOVARTIS Specialist, DRC (Development Regulatory Centers) Bachelors
degree in Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology Apply Now
Your responsibilities:
Your responsibilities include, but are not limited to:
Authoring/responsible for preparation of regulatory submissions
(e.g. ANDS, ANDA, SANDS) with support and guidance, applying agreed global
regulatory strategies, assuring technical congruency, and regulatory
compliance, meeting agreed upon timelines and requirements throughout project life
cycle.
Identify the required documentation for global submissions and
communicate expected delivery dates of technical source documents in accordance
with project timelines given by project management and SDC departments.
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 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 requirements
What you’ll bring to the role:
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 5 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.
Ability to work successfully with extended, multinational project
teams and coordinate activities simultaneously on multiple projects under
pressure of time and workload.
Effective planning, organizational and interpersonal skills.
Excellent written/spoken communication and negotiation skills.
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