Amneal Pharmaceuticals is now accepting applications from experienced Pharma professionals for Regulatory Affairs – MDI/DPI Inhalation roles.
Candidates must have a B.Pharm (mandatory) and would be preferred to have an M.pharm as well.
Applicants must have 4 to 8 years’ relevant experience in Regulatory Affairs, specifically in CMC submissions for inhaled products.
Any interested candidates with experience in US FDA ANDA submissions, EU regulatory requirements and MDI/DPI products are please to send through their updated CVS via email.
Candidates must have a B.Pharm (mandatory) and would be preferred to have an M.pharm as well.
Applicants must have 4 to 8 years’ relevant experience in Regulatory Affairs, specifically in CMC submissions for inhaled products.
Any interested candidates with experience in US FDA ANDA submissions, EU regulatory requirements and MDI/DPI products are please to send through their updated CVS via email.
Amneal Pharmaceuticals Recruitment – Job Overview
Amneal are looking for experienced Regulatory Affairs people to support their regulatory work on MDI and DPI products.
This is an opportunity for pharmaceutical professionals with experience in CMC Regulatory Affairs, regulatory submissions, product lifecycle and global regulatory compliance.
Job Details
| Particulars | Details |
| Company | Amneal Pharmaceuticals |
| Department | Regulatory Affairs |
| Job Role | Regulatory Affairs – MDI/DPI Inhalation |
| Qualification | B.Pharm (Mandatory), M.Pharm (Preferred) |
| Experience | 4–8 Years |
| Product Specialization | MDI / DPI Inhalation |
| Job Location | Not specified in the recruitment information |
| Application Mode | |
Amneal Pharmaceuticals Regulatory Affairs Job Responsibilities
Selected candidates will be responsible for the management of regulatory documentation, the preparation of submissions, the conduct of compliance assessments and the associated coordination activities relating to MDI/DPI inhalation products.
Key Responsibilities
- Compile, prepare, review and submit US ANDAS and EU Marketing Authorisation Applications for MDI/DPI inhalation products (original submissions and amendments).
- Carry out regulatory assessments to ensure compliance with US FDA, EU and all other relevant regulatory requirements.
- Prepare the Controlled Correspondence submissions and the pre-ANDA meeting packages for the CMC topics.
- Develop regulatory strategies for MDI/DPI products across the full lifecycle from development through to regulatory submission.
- Review Master Formula clearance, IIG clearance, device sameness, product specifications, stability protocols and CMC documentation.
- Review the Drug Master Files (DMFs) and work with the DMF holders and the procurement teams to deal with any regulatory comments in a timely fashion.
- Assess the Change Controls and their regulatory impact on approved and planned submissions.
- Work with cross functional teams, regulatory project managers and device suppliers to ensure we are ready to submit and that we file on time.
- Ensure compliance with the most up to date US FDA ANDA Checklist, EU requirements and applicable guidelines.
Eligibility & Qualifications
Candidates applying for the Amneal Pharmaceuticals Regulatory Affairs positions must meet the educational and experience requirements as set out for the MDI/DPI Inhalation role.
Educational Qualifications
- B.Pharm – Mandatory
- M.Pharm – Preferred
Experience Requirements
- 4 to 8 years of relevant professional experience.
- Experience in Regulatory Affairs and CMC activities with respect to MDI/DPI inhalation products.
- Familiarity with US ANDA’s and EU Marketing Authorisation Applications.
- Experience in regulatory documentation, submission preparation and compliance.
Required Skills for Amneal Regulatory Affairs Jobs
Candidates should possess knowledge and practical experience in the following areas:
- Regulatory Submissions and Compliance
- US FDA ANDA Requirements
- EU Regulatory Requirements
- CMC Regulatory Affairs
- Regulatory Intelligence
- Documentation and Data Governance
- Analytical Thinking and Problem-Solving
- Cross-functional Collaboration
- Strategic and Operational Planning
How to Apply for Amneal Pharmaceuticals Recruitment
Any interested and eligible candidates can apply by simply sending their up to date CVS directly to the recruitment email address.
Application Process
- Prepare your updated resume to highlight your Regulatory Affairs and CMC experience.
- Include your experience of US FDA ANDA and EU regulatory submissions.
- Highlight your exposure to MDI/DPI inhalation products.
- Mention your qualifications and total experience.
- Just send your updated CV to the recruitment email address provided below.
Email for Application: nandini.nair@amneal.com
Important Instructions
- B.Pharm qualification is mandatory.
- M.Pharm qualification is preferred.
- Candidates must have 4 to 8 years’ relevant experience.
- Relevant experience in MDI/DPI inhalation products is of course essential.
- Highlight your experience in US ANDA’s, EU submissions and CMC regulatory work on your CV.
Frequently Asked Questions
1. What roles are available at Amneal Pharmaceuticals?
Amneal Pharmaceuticals are recruiting for Regulatory Affairs – MDI/DPI Inhalation.
2. What are the qualifications required for Amneal Regulatory Affairs jobs?
B. Pharm is a must, M. Pharm is preferred. Pharm is preferred.
3. How much experience is required?
Candidates should have 4 to 8 years’ relevant experience.
4. Is MDI/DPI experience required?
The recruitment is specifically for MDI/DPI inhalation products. Relevant experience in that area is of course essential.
5. What are the key responsibilities?
Responsibilities include US ANDA and EU submission preparation, CMC documentation review, regulatory assessments, DMF coordination, Change Control evaluation and regulatory compliance.
6. How can candidates apply?
Eligible candidates can email their updated CVS to nandini.nair@amneal.com.
7. What is the final date to apply?
The recruitment ad doesn’t state an application deadline. Applicants should get in touch with the recruitment team for further information.
Job Summary
| Category | Details |
| Company | Amneal Pharmaceuticals |
| Vacancies | Regulatory Affairs – MDI/DPI Inhalation |
| Required Education | B.Pharm (Mandatory) / M.Pharm (Preferred) |
| Experience | 4–8 Years |