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