24 Aug
|
maya biotech private
|
Baddi
24 Aug
maya biotech private
Baddi
Are you an experienced
Drug Regulatory Affairs professional
looking to take the next step in your pharmaceutical career?
We’re looking for a detail-oriented and regulatory-focused professional to join our
Regulatory Affairs team
as a
DRA Executive
.
?
Location:
Baddi / Chandigarh
?
Department:
Regulatory Affairs
?
Designation:
DRA Executive
?
Reporting To:
Regulatory Affairs Manager / Head – Regulatory Affairs
?
Qualification:
B.Pharm / M.Pharm
⏳
Experience:
4–6 years in Pharmaceutical Drug Regulatory Affairs
? What You’ll Be Responsible For
As a DRA Executive, you will play an significant role in ensuring that our products and documentation remain
regulatory-compliant, accurate, and ready for approval and dispatch
.
Your key responsibilities will include:
• Managing and reviewing
regulatory dossiers
and ensuring completeness, accuracy, and alignment with approved product details.
• Reviewing critical regulatory documents including
manufacturing documents, specifications, COA, stability data, validation documents, licenses, approvals, CPP/COPP
,
and other applicable documents.
• Coordinating with
QA, QC, Production, Artwork, Commercial
, and other teams to ensure timely completion of regulatory documentation.
• Reviewing and maintaining documentation related to
product approvals, licenses, registrations, NOCs, and statutory requirements
.
• Reviewing
product artwork, labels, packing materials, and regulatory particulars
against approved documents and applicable guidelines.
• Verifying
MRP and pricing requirements
in accordance with
NPPA, DPCO, NLEM
, and other applicable regulations.
• Reviewing finished product packs/samples before dispatch to ensure correctness of
artwork, batch details, MRP, packing information, and regulatory declarations
.
• Assessing product approval requirements, including
DCGI/Central approvals and State Drug Authority approvals/NOCs
.
• Reviewing agreements from a regulatory perspective and ensuring appropriate product, man
📌 DRA Executive – Regulatory Affairs (Baddi)
🏢 maya biotech private
📍 Baddi