Senior Executive Regulatory Affairs
- Company Overview
- Job Role & Responsibilities
- Senior Executive – Regulatory Affairs (US Injectables)
- Eligibility / Qualifications
- Educational Requirements
- Experience Requirements
- Required Skills & Capabilities
- Location & Salary
- Application Process
- Frequently Asked Questions
- Who can apply for this role?
- Is injectable experience mandatory?
- Where is the job located?
- Is this a pre-approval focused role?
- What is the application deadline?
- Additional SEO Title Options
- Summary Table
Amneal hiring Senior Executive Regulatory Affairs in Ahmedabad. M.Pharm with US Injectables ANDA experience required.
Amneal Pharmaceuticals is hiring a Senior Executive – Regulatory Affairs (US Injectables, Pre-Approval) at its Ahmedabad location. This role is designed for experienced regulatory professionals with strong hands-on exposure to US FDA ANDA submissions for sterile injectable dosage forms. The position plays a critical role in driving timely approvals, minimizing regulatory deficiencies, and supporting Amneal’s injectable portfolio across regulated markets.
Company Overview
Amneal Pharmaceuticals is a global pharmaceutical company with a strong presence in complex generics, specialty products, and injectables for regulated markets including the United States. The organization is known for its regulatory strength, vertically integrated operations, and consistent focus on compliance, quality, and affordability in healthcare.
Amneal’s India operations support global regulatory submissions, CMC documentation, and lifecycle management for a wide portfolio of products. The Ahmedabad regulatory team works closely with R&D, manufacturing, quality, and global regulatory counterparts to ensure successful approvals and post-approval compliance for US FDA submissions.
Job Role & Responsibilities
The Senior Executive – Regulatory Affairs will be responsible for end-to-end regulatory activities related to US injectable ANDAs during pre-approval and post-approval phases.
Senior Executive – Regulatory Affairs (US Injectables)
Key Responsibilities
- Compile, prepare, review, and submit ANDAs and amendments to the US FDA with focus on avoiding major deficiencies and achieving timely approvals
- Maintain complete awareness of regulatory activities and timelines for assigned projects
- Handle sterile dosage form ANDAs including injectables, ophthalmic, otic, and IV bags
- Support submissions involving aseptic sterilization, terminal sterilization, or both
- Review and prepare regulatory documents acceptable to FDA without Refuse-to-Receive (RTR) issues
- Evaluate change controls and determine appropriate filing strategies (CBE, CBE-30, PAS)
- Compile and submit post-approval supplements and controlled correspondence
- Coordinate with R&D, QA, QC, manufacturing, and stability teams to ensure timely document availability
- Prepare pre-submission meeting packages such as Pre-ANDA, Pre-IND, and Pre-NDA
- Assess FDA deficiency letters, perform detailed gap analysis, and develop response strategies
- Evaluate IIG compliance, proportionality criteria, and regulatory risk mitigation strategies
- Review API DMFs and coordinate with purchase teams and DMF holders for timely resolution
- Maintain systematic archiving and tracking of all regulatory submissions
- Support regulatory strategy development across product lifecycle stages
- Be available for US time-zone teleconferences as required
Eligibility / Qualifications
Educational Requirements
- M.Pharmacy
Relevant Courses (comma-separated): M.Pharmacy (Pharmaceutics), M.Pharmacy (Pharmaceutical Technology), Regulatory Affairs, Industrial Pharmacy
Experience Requirements
- Strong prior experience in US FDA ANDA submissions for sterile injectable products
- Hands-on exposure to pre-approval and post-approval regulatory activities
Required Skills & Capabilities
- Advanced knowledge of US FDA regulations, ICH guidelines, and 21 CFR
- Expertise in ANDA, IND, NDA submissions and FDA correspondence
- Strong experience in CMC documentation and product lifecycle management
- Proven ability to handle health authority queries and deficiency responses
- Excellent technical writing and communication skills
- Strong planning, prioritization, and multi-tasking abilities
- High attention to detail and problem-solving skills
- Proficiency in MS Word, Excel, PowerPoint, Outlook, and Adobe Professional
Location & Salary
- Job Location: Shapath-V, Near Hotel Crowne Plaza, Ahmedabad, Gujarat – 380015
- Employment Type: Full-time
- Salary: Competitive and aligned with industry standards (based on experience)
Application Process
Interested candidates should apply through Amneal’s official career portal using the link below:
https://hcfa.fa.us2.oraclecloud.com/hcmUI/CandidateExperience/en/sites/AmnealIndiaCareers/job/6500
Candidates are advised to apply before January 30, 2026.
Frequently Asked Questions
Who can apply for this role?
Candidates with M.Pharm qualification and strong experience in US injectable ANDA submissions can apply.
Is injectable experience mandatory?
Yes. Experience with sterile injectable dosage forms is mandatory.
Where is the job located?
The position is based in Ahmedabad, Gujarat.
Is this a pre-approval focused role?
Yes. The role focuses heavily on pre-approval ANDA activities along with post-approval supplements.
What is the application deadline?
Applications should be submitted before January 30, 2026.
Additional SEO Title Options
- Amneal Hiring Senior Regulatory Affairs Executive – US Injectables
- Regulatory Affairs Jobs in Ahmedabad – ANDA Injectables
- Amneal Pharma Careers – US FDA Regulatory Affairs
Summary Table
| Company | Amneal Pharmaceuticals |
|---|---|
| Vacancies | Senior Executive – Regulatory Affairs |
| Required Education | M.Pharmacy |
| Experience | US Injectables ANDA Experience |
To apply for this job please visit hcfa.fa.us2.oraclecloud.com.
