Aurobindo Pharma is hiring experienced professionals for its Regulatory Affairs department at APLRC1, Hyderabad. The company is looking for candidates with experience in US regulatory affairs, particularly in CMC documentation, ANDA filings, and post-approval activities for oral solid dosage (OSD) products.
Candidates with an M.Pharmacy qualification and relevant pharmaceutical regulatory affairs experience can apply for the available positions.
Job Details
Company Name: Aurobindo Pharma
Department: Regulatory Affairs
Market: US Market
Job Location: APLRC1, Hyderabad, Telangana
Qualification: M.Pharmacy
Application Mode: Email
Email ID: Sreeja.Yangam@aurobindo.com
Available Positions and Requirements
1. Regulatory Affairs – CMC Topical/Nasal
Required Experience: 3–6 years
Qualification: M.Pharmacy
Preferred Skills: Hands-on experience in CMC (Chemistry, Manufacturing and Controls) documentation and regulatory filings for topical and nasal products.
2. Regulatory Affairs – CMC M3 / ANDA
Required Experience: 2–4 years
Qualification: M.Pharmacy
Preferred Skills: Hands-on experience with ANDA (Abbreviated New Drug Application) filings for oral solid dosage (OSD) products and CMC Module 3 documentation.
3. Regulatory Affairs – Post Approvals, LCM – OSD
Required Experience: 2–4 years
Qualification: M.Pharmacy
Preferred Skills: Hands-on experience in post-approval regulatory activities, life cycle management (LCM), and regulatory documentation for oral solid dosage products.
Key Responsibilities
Depending on the position, selected candidates may be responsible for preparing and reviewing regulatory documents, supporting US FDA submissions, maintaining CMC documentation, coordinating regulatory responses, and managing post-approval changes for pharmaceutical products.
Candidates should have a good understanding of US regulatory requirements, submission procedures, and pharmaceutical product documentation relevant to their chosen role.
How to Apply
Interested and eligible candidates can share their updated CV with the recruitment contact below.
Email: Sreeja.Yangam@aurobindo.com
Applicants should mention the relevant Regulatory Affairs position in the email subject line and highlight their experience in CMC filings, ANDA submissions, or post-approval activities, as applicable.
Note: The recruitment poster does not specify a last date to apply. Candidates are advised to confirm the current vacancy status before applying.
Frequently Asked Questions (FAQs)
1. What qualifications are required for Aurobindo Pharma Regulatory Affairs jobs?
Candidates must have an M.Pharmacy qualification. Relevant hands-on experience in the specific regulatory affairs function is preferred.
2. What is the required experience for these positions?
The CMC Topical/Nasal position requires 3–6 years of experience. The CMC M3/ANDA and Post Approvals–LCM OSD positions require 2–4 years of experience.
3. What is the difference between CMC and ANDA in regulatory affairs?
CMC refers to Chemistry, Manufacturing and Controls information covering the composition, manufacturing process, quality controls, and product specifications. ANDA is an Abbreviated New Drug Application submitted to the US FDA for approval of a generic drug.
4. What does post-approval life cycle management (LCM) involve?
Post-approval LCM involves managing regulatory changes after a product is approved, such as manufacturing site changes, formulation updates, process changes, and revisions to approved product documentation, according to applicable regulatory requirements.
5. How can eligible candidates apply for these vacancies?
Candidates can email their updated CV to Sreeja.Yangam@aurobindo.com. They should clearly mention the relevant position and their related regulatory affairs experience.
Aurobindo Pharma Recruitment: Regulatory Affairs Jobs for US Market in Hyderabad
The post Aurobindo Pharma Recruitment: Regulatory Affairs Jobs for US Market in Hyderabad appeared first on The Jobs Post –Job Alerts for Freshers & Experts.
