Principal Scientist

2 weeks ago

Hyderabad, Telangana, India Sandoz Full time
Job Description

Key Responsibilities:

- Strategy and delivery of PCS deliverables for products under development and in-market.
- Independently provide PCS inputs in PSURs, DSURs, annual reports, registrations, renewals and label updates for the delegated products.Addresses regulatory queries on delegated products.
- Conducts literature searches and analyzes relevant non-clinical safety data and decide benefit-risk of new nonclinical information in collaboration with patient safety experts.
- Contribute to the objectives and deliverables of (Global Project Team) in cross-functional collaboration with other GPT representatives.
- Evaluates the toxicological profiles of impurities, degradants and assess the specification limits based on ICH guidelines.
- Provides to nonclinical scientific writing support fo regulatory submission documents such as, IB, IND/CTA, NDA/BLA/MAA and Health Authority briefing books.
- Organizes nonclinical scientific activities and timelines in collaboration with authors for planned submission to meet strategic objectives of nonclinical submission deliverables.
- Develop expertise in internal Document management system to facilitate timely completion of projects and meet compliance requirement.
- Act as a nonclinical scientific liaison to Submissions & Documentation (S&D) vendor supporting nonclinical submission document management.
- Ensure that all the activities and deliverables are compliant with Novartis animal welfare policies, in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations.
- Be a team player and support local implementation of Preclinical safety strategies and independently contribute to multidisciplinary project/program goals within the Preclinical safety team. Communication skill is critical to this role in forming strong working relationships with team members and across functional disciplines.

Essential Requirements:

- PhD in life sciences with 6+ years experiences in drug discovery, drug development and/or life cycle management studies with an exceptional understanding of nonclinical submission writing
- In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics / pharmacodynamics, experience working in project teams, and knowledge of drug development and regulatory environment
- Understanding of GLP principles in nonclinical studies and submission writing.
- Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development.
- Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred.
- Excellent communicators, strong team players and have a high level of logistical/planning ability.Strong written and verbal capabilities in English preferred.
- Registration and certification with one of the International Toxicology registers.

Desirable Requirement:

- Animal Models ,Communication Skills, Data Analysis.
- Ethics ,Laboratory, Problem Solving.
- Regulatory Compliance.
- Research.
- Risk Assessment.
- Toxicology.

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