Executive/Sr. Executive, Regulatory Operations
Amneal Pharmaceuticals
Date: 2 weeks ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Description
QUALIFICATIONS
- 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
- B. Pharm
- M. Pharm
- 3 - 4 Years
How to apply
To apply for this job you need to authorize on our website. If you don't have an account yet, please register.
Post a resumeSimilar jobs
Inside Sales Specialist
Ingersoll Rand,
Ahmedabad, Gujarat
4 hours ago
Ingersoll Rand is committed to achieving workforce diversity reflective of our communities. We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion,...
Key Account Manager
BI Peru S.A.C.,
Ahmedabad, Gujarat
3 days ago
La P osición
El perfil de un Key Account Manager (KAM) para el área de acceso en Perú debe estar enfocado en buscar un profesional que lidere la implementación de las estrategias para lograr que los pacientes tengan acceso oportuno a los medicamentos y tecnologías de salud, trabajando con el sistema público y privado.
Tareas y Responsabilidades
Implementar estrategias de...
Project & Business Development Manager (m/f/d) — India
ICODOS,
Ahmedabad, Gujarat
1 week ago
ICODOS is a climate-tech startup developing deep-tech solutions to fight climate change — currently clean e-methanol plants. We're hiring a Project & Business Development Manager (m/f/d) based in India, focused on Gujarat and northern Maharashtra, our priority regions for Plant M's site and feedstock search.YOUR MISSIONSecure all required partners and sites for our clean e-methanol production plant (Plant M) in...
