Job Description

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.

Education:

• Master Degree (MS/MA) M.Pharm - Required

• Ph. D. Ph.D (Toxicology) - Preferred

Experience:

• 5 years or more in 5-8 Years

Specialized Knowledge: Licenses: Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.