Sandoz-Novartis Biotech & Biology Specialist Recruitment

Your responsibilities include, but are not restricted to:

• Authoring/responsible for preparation of regulatory submissions (e.g. ANDS, ANDA, SANDS) with support and assistance, applying agreed global regulatory strategies, assuring technological congruency, as well as regulatory compliance, meeting agreed-upon timelines and requirements throughout the project life cycle.
• Identify the required documentation for global submissions and communicate expected delivery dates of technological source documents in accordance with project timelines given by project management as well as SDC departments.
• Prepare query responses to health authority questions during development and registration in close collaboration with relevant SDC departments. Identify as well as rise as appropriate web content, quality and/or issues with source documents, or any other potential authorizing issues that might impact submission quality or timelines, as early as possible.
• Maintain knowledge approximately date when it comes to regulatory guidelines and also requirements in all global regions in addition to for new technical trends. Active participation as a member of the development team by adding to the regulatory strategy, identifying critical issues and applying lessons learned.
• Establish and maintain a sound working relationship with all Sandoz Regulatory affairs departments and also as well SDC teams. Interact with cross-functional teams in SDC, India for assigned development projects and also prepare timely query responses, as appropriate.
• Support to DRC manager for a global regulatory strategy for developments projects with a focus on creativity as well as innovation, maximizing the business benefit balanced with regulatory compliance. Assume specialized assignments as assigned as well as represent own departments in cross-functional project teams.
• Various other tasks as assigned by the supervisor, as well as tasks based on a specific appointment. Various other tasks determined during the yearly objectives setting process and also by KPIs.Implementation of and also compliance with all the instructions and also requirements for safety at work, environment protection, and also property protection.

Minimum requirements:

What you’ll give the role:

• Minimum– Degree in Science (e.g. Bachelors degree in Biochemistry, Biotechnology, Biology) or equal Desired– Advanced Degree in Science (Bachelors/Masters/Ph. D. in Chemistry.
• Regulatory experience mandatory (minimum of 5 years), and/or experience in the pharmaceutical industry in the United States, EU, Most of the global market etc. Solid knowledge of ICH, EMA, US FDA standards and also regulatory procedures.
• Working knowledge of chemistry, analytics or pharmaceutical technology. Knowledge of the drug development of process desirable. Ability to critically assess data from a wide range of science disciplines.
• Capability to work successfully with prolonged, international project teams and also coordinate activities simultaneously on multiple projects under pressure of time and also work.
• Effective preparation, organizational and also interpersonal skills.
• Excellent written/spoken communication as well as negotiation skills.