Amneal Pharma hiring Regulatory Affairs (Post Approval) B.Pharm/M.Pharm, 2-7 yrs exp

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), a global pharmaceutical company, is seeking talented professionals to join our Regulatory Affairs – Post Approval team in Ahmedabad. We are looking for candidates with 2-7 years of relevant experience. If you are seeking Amneal Regulatory Affairs Ahmedabad opportunities, this is your chance to join a growing and dynamic organization.

These Amneal Regulatory Affairs Ahmedabad roles offer a chance to contribute to the post-approval activities of a diverse portfolio of high-quality medicines. We are looking for individuals with a strong understanding of ANDA submission activities and USFDA guidelines.

Why Join Amneal Pharmaceuticals in Ahmedabad?

Global Company: Be part of a leading global pharmaceutical company.
Diverse Portfolio: Work with a diverse portfolio of 270+ high-quality medicines.
Career Growth: Opportunities for professional development and advancement.
Impactful Work: Contribute to making healthy possible for patients worldwide.

Regulatory Affairs (Available Position and Requirements:

Department: Regulatory Affairs – Post Approval

Designation: Executive/Senior Executive
Location: Ahmedabad
Qualification: B.Pharm/M.Sc./M.Pharm
Experience: 2-7 Years
Required Skills:
- Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
- API DMF review with respect to USFDA regulatory requirements.
- Exposure to Solid oral dosage form/Sterile dosage form/complex dosage form/topical-Inhalation dosage form and brief manufacturing process and key regulatory aspects.
- Ability to preliminary review change cases with respect to ICH quality/post-approval USFDA guidance and awareness of post-approval submission guidelines and procedures for Annual reports/CBE 0/CBE 30 and PAS filings.
- Drafting of Annual Reports with required submission data as per USFDA guidance.
- Drafting controlled correspondence/Briefing Packages to the FDA on specific cases as needed for assigned projects.
- Awareness of FDA recommendations on commercial marketing status notification submissions in terms of content and time frames.

Detailed Role Descriptions

Regulatory Affairs Executive/Senior Executive (Post Approval):
- Manage post-approval activities for pharmaceutical products.
- Ensure compliance with USFDA and ICH guidelines.
- Review API DMFs and prepare regulatory submissions.
- Draft and submit annual reports, CBEs, and PAS filings.
- Communicate with the FDA on regulatory matters.

Qualifications and Skills

Candidates must possess a B.Pharm, M.Sc., or M.Pharm degree.
2-7 years of relevant experience in regulatory affairs, particularly post-approval activities.
Strong understanding of ANDA submissions and USFDA guidelines.
Excellent documentation and communication skills.
Ability to work in a team environment.

How to Apply

Interested candidates can share their CVs with [email protected] and [email protected].

Location and Company Information

Location: Ahmedabad
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) is a global pharmaceutical company.

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