Executive - Drug Regulatory Affairs - US / Canada
Alkem Laboratories
- Posted: 4 months ago
- Openings: 10
- Applicants: 0
Job Description
- Prepare and submit ANDA postapproval submissions (CBE, CBE30, PAS, Annual Reports).
- Ensure timely responses to FDA deficiencies.
- Coordinate with internal and external stakeholders for postapproval and deficiency documentation.
- Follow up with crossfunctional teams to meet regulatory timelines.
- Review and support technical documents for deficiency responses (development reports, BMR, BPR, validations, specifications, change controls).
- Work as a team member to achieve department objectives.
More Info
Education
Any Graduate
Not Disclosed
Required Skills
Regulatory Affairs
anda
Dossier Preparation
Dossier
Regulatory
Canada
Drug
Drug Regulatory Affairs
Contact Details
Alkem Laboratories
+91 987654567
contact@alkem.com
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