Amneal Pharmaceuticals

Assistant Manager, Medical Affairs - R&D Injectable

Amneal Pharmaceuticals  •  State of Gujarāt, IN (Onsite)  •  2 hours ago
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Job Description

Candidate with strong 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:

Education:

  • MBBS

Experience:

  • 5 years or more

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.

Amneal Pharmaceuticals

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

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Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.

Industry
Chemicals & Materials
Company Size
5,001-10,000 employees
Headquarters
Bridgewater, New Jersey
Year Founded
2002
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