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Akums Pharmaceuticals is a leading contract manufacturer known for its high-quality formulations across diverse therapeutic segments. With multiple certifications and accolades, we provide an ideal platform for professionals who want to make a meaningful contribution to healthcare. Akums values diversity and encourages women candidates to apply, ensuring a work culture that promotes equal opportunities.
Role & Responsibilities of the DRA Officer
As a DRA (Drug Regulatory Affairs) Officer, you will play a key role in managing regulatory documentation and ensuring compliance with regulatory bodies like CDSCO and DCGI. Your responsibilities will include:
Coordinating with the R&D team for AMD, AMV, tech transfers, stability charging dates, and timelines.
Following up with the Purchase Department for vendor API documents and reviewing them.
Compiling and reviewing dossiers for both finished products and APIs.
Preparing technical documents such as package inserts, rationales, and drug-drug interaction summaries.
Reviewing artwork for DCGI submissions.
Preparing and submitting dossier modules (Module 1, 2, 3, 4 & 5) to CDSCO.
Compiling dossiers for IPC submissions and handling subsequent queries independently.
Managing applications for import of new APIs and RLDs (CT-16).
Handling Form-29 applications (CT-10, CT-12, and CT-12).
Responding to technical queries from the Business Development Department.
Communicating with CROs regarding BE, CT, and Toxicity Protocols (including site additions, site initiations, and IMP documentation).
Reviewing Clinical Trial (CT) and Bioequivalence (BE) protocols.
Managing Form-12 and CT-17 applications to CDSCO.
Required Qualifications
Degree: B.Pharm / M.Pharm
Experience: 0-1 year (Freshers are welcome to apply)
Skills and Attributes
Strong understanding of pharmaceutical regulatory requirements and processes.
Basic knowledge of dossier preparation and submission modules.
Good communication skills to coordinate with multiple departments and clients.
Familiarity with CDSCO guidelines and regulatory protocols.
Attention to detail in preparing and reviewing technical documents.
Kindly share your Resume nikita.sehgal@akums.net