Regulatory Affairs Executive

Job Title: Regulatory Affairs Specialist

Department: Regulatory Affairs

Location: HO Office, Gota Ahmedabad

Company name : Noronic pharmaceutical

Job Summary:
The Regulatory Affairs Specialist is responsible for ensuring compliance with regulatory requirements, overseeing the preparation of technical documents, and supporting product registration and lifecycle management. The role involves working on stability studies, product development reports (PDR), analytical method validation (AMV), process validation (PV), Summary of Product Characteristics (SmPC), artwork checks, and other technical and regulatory documentation.

Key Responsibilities:
1. Regulatory Documentation Management:
Prepare, review, and submit regulatory dossiers to health authorities, ensuring compliance with global and local regulatory requirements.

Develop and review Product Development Reports (PDR), Analytical Method Validation (AMV) protocols, and Process Validation (PV) reports.

Ensure the accurate completion of technical documents, including SmPC, Certificate of Analysis (COA), and Method of Analysis (MOA).

2. Stability Studies:
Design and monitor stability studies in accordance with ICH guidelines.

Interpret stability data to determine product shelf-life and recommend storage conditions.

Prepare stability reports for regulatory submissions.

3. Process Validation (PV):
Collaborate with manufacturing and quality teams to prepare and review Process Validation (PV) protocols and reports.

Ensure PV activities are conducted in compliance with regulatory requirements.

Analyze PV data to verify consistency and reproducibility of manufacturing processes.

4. Artwork Review and Approval:
Review and approve product artwork and labeling to ensure compliance with regulatory and company guidelines.

Coordinate with design teams to incorporate regulatory updates into packaging materials.

Verify alignment between artwork and approved SmPC or product dossiers.

5. Specifications and Analytical Methods:
Review and approve analytical method protocols, validation reports, and product specifications.

Ensure specifications meet pharmacopeial standards and regulatory expectations.

6. Comparative Documentation and Bioequivalence Studies:
Review Comparative Documentation Packages (CDP) to ensure compliance with dossier requirements.

Support Bioequivalence (BE) studies by reviewing protocols and analyzing results for submission.

7. Regulatory Support for Product Lifecycle Management:
Monitor and implement updates to product information, labeling, and regulatory documents.

Stay informed on regulatory changes and their impact on ongoing and future submissions.

Key Skills and Competencies:
Strong understanding of regulatory guidelines (e.g., ICH, FDA, EMA, WHO).

Expertise in stability, process validation (PV), PDR, AMV, and artwork checks.

Analytical and problem-solving skills for interpreting stability, PV, and BE study data.

Attention to detail and proficiency in technical document preparation.

Strong communication, organizational, and time-management skills.

Qualifications and Experience:
Education: Master’s degree in Pharmacy, Chemistry, or a related field.

Experience: 3-5 years of experience in regulatory affairs or a related role in the pharmaceutical industry.

Technical Knowledge: Experience with stability, process validation, artwork review, and dossier preparation (eCTD expertise preferred).

Pay: ₹12,263.53 - ₹47,669.47 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift
- Fixed shift

Supplemental Pay:

- Performance bonus
- Yearly bonus

Work Location: In person