Assistant Manager – Biologics / Biosimilars at Amneal Pharmaceuticals
An Amneal careers opportunity has emerged for aspiring professionals in the field of Regulatory Affairs. Amneal Pharmaceuticals is seeking an Assistant Manager specializing in Biologics and Biosimilars to join their team in Ahmedabad, Gujarat. Candidates with relevant qualifications and experience are encouraged to apply promptly.
About the Company
Amneal Pharmaceuticals is a global pharmaceutical company dedicated to providing high-quality medicines to patients. The organization is involved in the development, manufacturing, and commercialization of a wide range of pharmaceutical products, including generics, specialty pharmaceuticals, and biosimilars. With a commitment to innovation and patient care, Amneal operates in various international markets, ensuring access to essential medications.
Job Details:
- Position: Assistant Manager – Biologics / Biosimilars
- Location: Ahmedabad, Gujarat, India
- Qualification: M.Pharm / M.Sc / Ph.D. in Biotechnology, Biochemistry, Life Sciences, or related discipline
- Experience: 3-10 years in Regulatory Affairs for Biologics/Biosimilars
Job Description
In this Amneal careers role, the Assistant Manager will support global regulatory activities for Biologics and Biosimilars across key international markets. This role includes collaboration with cross-functional teams on product development, registration, lifecycle management, and global regulatory strategy.
Key Responsibilities
- Prepare, review, and submit regulatory dossiers for global markets, including the US FDA and EMA.
- Author and review CTD/eCTD modules with a strong focus on CMC documentation for biologics and biosimilars.
- Support preparation and submission of IND, IMPD, BLA, MAA, and other regulatory applications as applicable.
- Coordinate and manage responses to regulatory agency queries, deficiency letters, and information requests within defined timelines.
- Contribute to regulatory strategies supporting development, registration, and lifecycle management of biologics and biosimilars.
- Monitor emerging regulatory requirements and assess the impact of new US FDA, EMA, ICH, and global guidelines on development programs.
- Manage post-approval regulatory activities including variations, supplements, renewals, annual reports, labeling updates, and change management submissions.
- Collaborate closely with R&D, Process Development, Analytical Development, Manufacturing, Quality Assurance, Clinical, and Pharmacovigilance functions.
Eligibility Criteria
- Hands-on experience in Regulatory Affairs for Biologics and Biosimilars.
- Strong understanding of biologics CMC requirements.
- Experience in preparing and reviewing submissions for US FDA and EMA markets.
- Familiarity with biosimilar regulatory pathways.
- Strong analytical, communication, and stakeholder management skills.
- Experience in sterile injectables, oncology, immunology, or specialty biologics will be an added advantage.
How to Apply
Interested candidates are encouraged to apply and share their CV at nandini.nair@amneal.com with a cc to pujas@amneal.com.
Why Join?
This role offers the opportunity to work on cutting-edge biologics and biosimilars programs while collaborating with global teams and contributing to products that impact patient lives worldwide.
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
This Amneal job opening provides a unique opportunity for qualified candidates to contribute significantly to the field of Regulatory Affairs. Those interested in advancing their careers in a dynamic environment are encouraged to apply before the deadline.
