Amneal Hiring Pharmacy Graduates | Regulatory Operations Role
Amneal eCTD jobs offer aspiring Regulatory Operations professionals in India an opportunity to manage eCTD publishing and submissions in compliance with regulatory guidelines. The organization is seeking a Senior Officer with a background in B.Pharm and 1-4 years of experience.
About Amneal Pharmaceuticals
Amneal Pharmaceuticals is a global pharmaceutical company operating in the healthcare sector, dedicated to providing high-quality generic and specialty medications. With a strong focus on innovation and compliance, Amneal is committed to meeting the needs of patients and healthcare providers worldwide.
Company: Amneal Pharmaceuticals
Position: Regulatory Operations Senior Officer (eCTD)
Location: India
Education: B.Pharm (Required), M.Pharm (Preferred)
Experience: 1-4 years
Deadline: 29 September 2026
Note:: The application deadline stated in the source notification may have passed. Verify before applying.
Amneal eCTD Jobs: Job Description
This role, listed among Amneal eCTD jobs, requires good knowledge of regulatory guidelines related to eCTD publishing and submissions, primarily ICH M4, M8, and FDA eCTD guidances. Responsibilities include preparing, compiling, and publishing high-quality eCTD sequences for ANDAs, NDAs, Amendments, and Supplements in alignment with USFDA eCTD technical specifications and ICH guidelines.
Key Responsibilities
- Own Module 1 (US-regional) requirements and ensure correct placement/metadata for cover letters and forms (356h).
- Prepare and compile eCTD submissions in compliance with regulatory standards.
- Maintain up-to-date knowledge of eCTD publishing guidelines.
- Collaborate with cross-functional teams to ensure timely submissions.
- Review and validate eCTD sequences for accuracy and completeness.
Eligibility Criteria
- B.Pharm degree is required; M.Pharm is preferred.
- 1-4 years of relevant experience in regulatory operations.
- Familiarity with eCTD publishing and submissions.
How to Apply
Interested candidates can apply online by following the link: CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
Why Join Amneal Pharmaceuticals
Joining Amneal Pharmaceuticals offers a unique opportunity to be part of a dynamic organization that values innovation and compliance. The company is committed to fostering a collaborative work environment where employees can grow professionally while contributing to the health and well-being of patients globally.
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
For qualified candidates, Amneal eCTD jobs such as this role present a compelling opportunity to advance a career in regulatory operations. Interested individuals are encouraged to apply before the deadline to seize this chance to contribute to a leading pharmaceutical organization.
