Regulatory Affairs Sr Executive

# Job Role: QRA / IRA Sr. Executive

## Eligibility & Qualifications

* Only experienced candidates can apply.

* Required qualifications: BSc, MSc, B.Pharm, M.Pharm

share your cv on hr@noronicpharma.com

## Key Responsibilities

### 1. Dossier Preparation

* Independently prepare ACTD and CTD dossiers.

* Compile prepared and review modules including:

 * Pharmacovigilance (PV)

 * PVP prepared

 * Stability prepared

 * SPECT, COA, and MOA prepared

 * Stability data

 * Product Development Report (PDR)

 * Specifications (SPECT)

 * Certificate of Analysis / Method of Analysis (COA / MOA)

 * Summary of Product Characteristics (SMPC)

 * Bioequivalence (BE) study review

 * CDP matching

 * BIT form preparation

 * Analytical Method Validation (AMV) preparation

 * Drug Master File (DMF) preparation

 * Batch Manufacturing Record (BMR) preparation

 * Batch Packing Record (BPR) preparation

### 2. Regulatory Documentation & Compliance

* Prepare, draft, and submit all legal documentation including:

 * COPP

 * PP

 * FSC certification

* Ensure timely application, follow‑up, and completion of approval processes.

### 3. Regulatory Queries & Communication

* Handle and resolve regulatory queries from various countries.

* Coordinate with international regulatory bodies, authorities, and internal departments.

### 4. Coordination & Support

* Work closely with QA, QC, Production, R&D, and marketing teams to gather and verify required documents.

* Maintain accurate regulatory records and ensure documentation meets global regulatory standards.

### 5. Continuous Improvement

* Keep updated with regulatory guidelines of different countries.

* Support in upgrading dossier quality and compliance processes.

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If you'd like to add qualifications, skills, salary range, or responsibilities in more detail, I can update this further.