Associate, DRC - Hyderabad / Secunderabad @ Novartis Healthcare

294936BR

Job Description

1886! We have more than 130 years of experience treating patients.
Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide. 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, ing 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 ing 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 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 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.
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.