Executive, Regulatory Affairs
Amneal Pharmaceuticals · Ahmedabad · onsite · Posted 45d ago
Not disclosed5–8 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
Job Description
QUALIFICATIONS
- Good knowledge of ANDA submission activities and post-approval procedures and related ICH and USFDA guidelines.
- API DMF and DMF Change Notification review with respect to USFDA regulatory requirement.
- Exposure of the 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 the change cases with respect to ICH quality / post approval USFDA guidance and aware for Post approval submission guideline and procedure for Annual report/CBE 0/CBE 30 and PAS filling
- Drafting of the Annual Report with required submission data as per USFDA guidance.
- Preliminary review of entire submission package.
- Drafting the controlled correspondence/Briefing Package to FDA on specific cases as needed for assigned projects.
- Awareness about the FDA recommendation on the commercial marketing status notification submission in terms of content and time frames.
- Coordination with Cross Functional teams for the documents availability as per regulatory submission plan.
- Ensure the no delay in drafting and compiling the regulatory submission.
- Maintain regulatory information as per allocated task.
- Having good Regulatory CTD modules drafting & preliminary review skills.
QUALIFICATIONS
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 5 years or more in 5 - 8 Years
Sourced from foundit
Skills
Manufacturing ProcessUSFDA guidelinesRegulatory aspectsANDA submission activitiescomplex dosage formpost-approval proceduresRegulatory CTD modules draftingSolid oral dosage formSterile dosage formtopical-Inhalation dosage formCBE 0CBE 30DMF Change Notification review
About Amneal Pharmaceuticals
Amneal Pharmaceuticals
Pharma
5.5k+
employees
2002
24 years old
Bridgewater, New Jersey
United States (USA)
About
Amneal Pharmaceuticals operates in the pharmaceutical sector, focusing on developing accessible and affordable medicines to address critical healthcare challenges.
Industries
PharmaBiotechnologyClinical Research
Employee ratings
1,455 reviews
4.2/ 5
Culture
4.0
Career growth
3.5
Work-life
4.2
Employees rate it well for
Work Culture190Senior Management93Work Life Balance87Work Environment69HR Policies65
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