Description

JOB DESCRIPTION

Candidate with robust expertise in clinical pharmacology and pharmacokinetics (PK) to identify and evaluate drug candidates suitable for development via the 505(b)(2) regulatory pathway. The role focuses on leveraging existing clinical, safety, and efficacy data of approved products to propose differentiated formulations addressing unmet clinical needs.

Essential Functions

- Identify potential drug molecules suitable for 505(b)(2) development based on scientific, clinical, and commercial rationale.
- Critically review published and regulatory data (PK, safety, efficacy, bioavailability) from approved products, literature, and databases.
- Assess clinical unmet needs and define opportunities for improved formulations (e.g., long-acting injectables, depot systems, novel delivery platforms).
- Propose formulation strategies aligned with pharmacokinetic and therapeutic objectives.
- Support development of clinical and regulatory strategies for 505(b)(2) submissions.
- Collaborate with formulation R&D;, regulatory, and business teams to prioritize development candidates.
- Prepare scientific justifications, gap analyses, and development proposals for internal decision-making.

Additional Responsibilities

QUALIFICATIONS

Education

- MBBS

Experience

- 5 years or more

About Us

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.

About The Team

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.

📌 Assistant Manager, Medical Affairs - R&D Injectable (Ahmedabad)
🏢 Amneal Pharmaceuticals
📍 Ahmedabad