Novartis Pharma & Chemistry Regulatory Associate Vacancy – Apply
Novartis pharma and chemistry job opening 2022. M Pharma job opening 2022, Pharma job opening 2022, Development Regulatory Centers (DRC) Associate pharma job opening 2022. M Pharma & PhD chemistry job opening 2022, Chemistry associate job opening 2022. Intrested and eligible candidates may check out all the details on the same below:
Job ID: 345316BR
Job Title: Development Regulatory Centers (DRC) Associate
Eligibility Criteria:
What You’ll bring to the role:
• A minimum of 2 years of experience in regulatory affairs preferred. A postgraduate in pharmacy in regulatory affairs is desirable. Advanced Degree in Science (Bachelors/Masters/Ph.D. in Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent
• Working knowledge of chemistry, analytics, or pharmaceutical technology. Knowledge of the drug development the process is desirable. Ability to critically evaluate data from a broad range of science disciplines.
• Good knowledge of ICH, EMA, US FDA guidelines, and regulatory procedures.
• 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.
• Fluent English required (oral and written). Local Language
knowledge will be a benefitYour Responsibilities:
Your responsibilities include but not are limited to:
• Support DRC in preparation of regulatory submissions (e.g. ANDS, ANDA, SANDS) as well as query responses to health authority questions during development and registration in close collaboration with relevant SDC departments.
• 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.
• 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 the development team by contributing to the regulatory strategy, identifying critical issues, and applying lessons learned.
• Establish and maintain sound working relationships with all Sandoz Regulatory affairs departments and as well SDC teams. Support DRC manager/specialist for a global regulatory strategy for development projects with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.
• Assume specialized assignments as assigned and represent own department in cross-functional project teams. Other tasks as assigned by the supervisor and tasks based on a specific appointment.
• Other tasks are 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.
Apply Online
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