To support Global Toxicology and Non-Clinical Development for drug products across all dosage forms - including injectables, oral solids, topicals, ophthalmic and otic formulations -providing extended support to both R&D and non-R&D functions (all manufacturing sites) across all Amneal global locations, including India and the US.
Essential Functions:
- Closely and effectively collaborate with key cross-functional teams to drive the strategic execution of non-clinical and regulatory initiatives, ensuring alignment with overall project and organizational goals.
- Analytical R&D – for impurity qualification, method validation support, and extractables/leachables (E&L) assessments.
- Formulation R&D – to align on excipient safety, formulation-related toxicity concerns, and novel delivery system requirements.
- Regulatory Affairs – for synchronized planning and preparation of non-clinical components in global submissions (ANDA, NDA 505(b)(2), etc.).
- Clinical Teams – to support early clinical safety data interpretation and provide preclinical context.
- Manufacturing Plants/Sites – for setting health-based exposure limits (HBEL, OEL), supporting tech transfers, and ensuring compliance in production settings.
- Procurement Team – to support the identification, evaluation, and onboarding of CRO partners.
- Finance, Legal, and Project Management – to ensure timely contracts, budgets, and milestone management.
- Portfolio, Ideation, and Business Development Teams – to provide early nonclinical feasibility input during product selection and innovation pipeline evaluations.
Additional Responsibilities:
- Coordinate shipment logistics of test items (e.g., formulations) from various Amneal global sites to designated Contract Research Organization (CRO) facilities, ensuring compliance with study timelines and storage/transport conditions.
- Collaborate with Legal teams to draft, review, and finalize Confidentiality Disclosure Agreements (CDA), Master Service Agreements (MSA), and other project-specific contractual documentation.
- Liaise with Finance teams to track, manage, and resolve payment-related matters tied to CRO services and engagements.
- Partner with Quality Assurance teams to support and facilitate quality audits and compliance assessments of non-clinical CROs, reinforcing GLP standards and regulatory alignment.
- Actively participate in webinars, workshops, and scientific seminars to maintain subject matter expertise and stay current with industry trends, regulatory changes, and emerging methodologies in toxicology and nonclinical sciences.
Qualifications
- Master Degree (MS/MA) M.Pharm - Required
- Ph. D. Ph.D (Toxicology) - Preferred
- 5 years or more in 5-8 Years
About Company
The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key roles that the Human Resources team performs:
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.
Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.