Viharsh Lifescience Pvt. Ltd. has announced a new hiring opportunity for Regulatory Affairs professionals. The company is inviting applications from B.Pharm and M.Pharm graduates with 6 months to 1 year of experience in Regulatory Affairs (ROW). This is an excellent opportunity for candidates looking to build a career in global regulatory submissions and pharmaceutical documentation.

If you are an Ahmedabad-based candidate or an immediate joiner, this vacancy offers an excellent chance to work with a growing pharmaceutical organization focused on quality, compliance, and integrity.

Job Overview

Particular Details

Company Name

Viharsh Lifescience Pvt. Ltd.

Job Role

Regulatory Officer to Sr. Officer

Department

Regulatory Affairs

Industry

Pharmaceutical

Qualification

B.Pharm / M.Pharm

Experience

6 Months – 1 Year (ROW Regulatory)

Preferred Candidates

Ahmedabad Local Candidates & Immediate Joiners

Working Hours

9:00 AM – 6:00 PM

Job Location

Bopal, Ahmedabad, Gujarat

Employment Type

Full-Time

About Viharsh Lifescience Pvt. Ltd.

Viharsh Lifescience Pvt. Ltd. is a pharmaceutical company engaged in manufacturing Finished Dosage Formulations and Active Pharmaceutical Ingredients (API). The organization emphasizes Compliance, Quality, and Integrity while serving regulated and ROW markets through high-quality pharmaceutical products.

Key Responsibilities

Selected candidates will be responsible for:

Preparation and compilation of CTD/ACTD dossiers for ROW countries.

Preparation of regulatory query responses.

Preparation of PSUR, RMP, and PSMF documentation.

Opening and closing part of Drug Master Files (DMF).

Support for Bioequivalence (BE) study protocols and clinical regulatory documents.

Preparation of AMV protocols, reports, and chromatograms.

CDP preparation and review.

Nitrosamine risk assessment reports.

Process Validation (PV) protocols and reports.

Stability study documentation.

Product Development Report (PDR).

Batch Manufacturing Record (BMR) and Batch Packing Record (BPR) preparation.

SmPC and Patient Information Leaflet (Package Insert) preparation.

Review and preparation of other technical regulatory dossiers.

Eligibility Criteria

Candidates should possess:

B.Pharm or M.Pharm qualification.

6 months to 1 year of Regulatory Affairs experience.

Knowledge of ROW regulatory documentation.

Good documentation and communication skills.

Ability to work with international regulatory projects.

Immediate joining will be preferred.

Required Skills

CTD & ACTD Dossier Preparation

DMF Documentation

Regulatory Submission

Technical Writing

Pharmaceutical Documentation

Process Validation

Stability Documentation

Good Documentation Practices (GDP)

Regulatory Compliance

MS Office

Why Join Viharsh Lifescience?

Work on Global (ROW) Regulatory Projects.

Career growth with experienced professionals.

Exposure to international pharmaceutical documentation.

Quality-driven work environment.

Opportunity to develop technical regulatory expertise.

How to Apply

Interested candidates can share their updated resume through the official contact details provided in the recruitment advertisement.

Company: Viharsh Lifescience Pvt. Ltd.

Location: Office No. 514, 5th Floor, Satyamev Elite, Above Zudio, Opp. BRTS Junction, Bopal, Ahmedabad, Gujarat, India.

Technical FAQs

1. What is CTD/ACTD in Regulatory Affairs?

CTD (Common Technical Document) and ACTD (ASEAN Common Technical Document) are internationally accepted formats used for submitting pharmaceutical product registration dossiers to regulatory authorities.

2. What is a Drug Master File (DMF)?

A Drug Master File (DMF) is a confidential document submitted to regulatory agencies containing detailed information about the manufacturing process, facilities, quality control, and stability of pharmaceutical ingredients.

3. What is the purpose of PSUR and PSMF?

PSUR (Periodic Safety Update Report) provides updated information on the safety profile of a marketed medicine, while PSMF (Pharmacovigilance System Master File) describes the company’s pharmacovigilance system used for monitoring drug safety.

4. Why is Process Validation (PV) important in pharmaceuticals?

Process Validation ensures that manufacturing processes consistently produce products meeting predefined quality standards, regulatory requirements, and Good Manufacturing Practices (GMP).

5. What are SmPC and Patient Information Leaflets?

The Summary of Product Characteristics (SmPC) provides detailed scientific information for healthcare professionals, while the Patient Information Leaflet (PIL) contains medicine usage instructions, warnings, dosage, and precautions for patients.