M Pharm Job at Amneal | Regulatory Affairs Job
Looking for a Regulatory Affairs Job in the pharma industry? Amneal Career offers an excellent opportunity for candidates seeking an M Pharm Job as a Regulatory Executive in Ahmedabad. This role is ideal for professionals interested in eCTD Publishing Jobs and Pharma Jobs in Ahmedabad. Apply now to join Amneal Career and build expertise in FDA submissions, ICH guidelines, and regulatory operations in a dynamic pharmaceutical environment.
About Amneal Pharmaceuticals
Amneal Pharmaceuticals is a global pharmaceutical company focused on delivering high-quality medicines worldwide. Amneal Career provides excellent opportunities for candidates seeking M Pharm Jobs, Regulatory Affairs Jobs, and Pharma Jobs in Ahmedabad. With strong regulatory capabilities and global operations, the company offers a professional work environment where employees can grow in regulatory executive roles and contribute to international pharmaceutical submissions.
- Position: Executive/Sr. Executive, Regulatory Operations
- Location: Ahmedabad City, Gujarat, India
- Job Identification: 7710
Job Description
Having good knowledge of the regulatory guidelines related to eCTD publishing and submissions, mainly ICH M4, M8, and FDA eCTD guidance.
- Prepare, compile, and publish high-quality eCTD sequences for ANDAs/NDAs/Amendments/Supplements in alignment with USFDA eCTD technical specifications and ICH guidelines.
- Own Module 1 (US regional) requirements and ensure correct placement/metadata for cover letters, forms (356h), labeling (SPL), REMS, correspondence, and ESG submission properties.
- Ensure accuracy and consistency across Module 2 summaries and Module 3 (CMC/Quality), with correct granularity, file naming, and document locations per eCTD backbone.
- Execute precise PDF publishing standards: pagination, bookmarks, hyperlinks, table of contents, headers/footers, legibility, OCR, and accessibility compliance.
- Perform end-to-end pre-publish checks and validations; resolve all technical errors/warnings; troubleshoot link/file/path, STF, and schema issues prior to finalization.
- Manage lifecycle operations (new, replace, append, delete) with proper leaf tracking and sequence continuity, maintaining audit trails and version control.
- Define and maintain sequence metadata (submission type, sequence number, submission description, related sequence references) with zero defect accuracy.
- Coordinate cross-functionally with Regulatory, CMC, Nonclinical/Clinical, and Labeling teams to secure submission-ready documents on time.
- Prepare and submit through FDA ESG, monitor and interpret ACK1/ACK2/ACK3, and rapidly address transmission errors with IT/ESG support.
- Monitor and implement updates to USFDA eCTD Technical Conformance Guide, regional Module 1 specs, validation rules, and eCTD v4.0 transition requirements.
- Execute Study Tagging Files (STFs) where applicable; validate structure and relationships for quality/nonclinical/clinical study sections.
Qualifications
- Education: B. Pharm, M. Pharm
- Experience: 3 – 4 Years
This Regulatory Affairs Job at Amneal Career is a great opportunity for candidates seeking an M Pharm Job and a Regulatory Executive role in Pharma Jobs Ahmedabad. With hands-on experience in eCTD publishing, FDA submissions, and regulatory compliance, this role offers strong career growth in the pharmaceutical industry. If you are passionate about regulatory operations and global submissions, apply now and advance your career with Amneal.
