Viharsh Hiring Regulatory Affairs Officer, Executive

BPharm MPharm RA Jobs Ahmedabad Viharsh

B.Pharm/M.Pharm apply for Regulatory Affairs vacancies in Ahmedabad at Viharsh Lifescience. 6 months–3 yrs experience, multiple openings.

Viharsh Lifescience Pvt. Ltd. is hiring Regulatory Affairs professionals at Officer to Executive levels for its Ahmedabad office. This is a focused opportunity for candidates aiming to build a strong career in global regulatory submissions, CTD dossier preparation, and pharmaceutical compliance.

If you are targeting high-growth pharma careers in Regulatory Affairs, clinical documentation, or global submissions (ROW markets), this role offers hands-on exposure to end-to-end dossier preparation and regulatory lifecycle management.

Company Overview

Viharsh Lifescience Pvt. Ltd. operates in the pharmaceutical and life sciences domain with a strong focus on regulatory compliance, quality systems, and global submissions. The company supports API and finished formulation businesses through structured regulatory strategies and documentation aligned with international guidelines.

Working with Viharsh provides exposure to CTD/ACTD dossier preparation, DMF lifecycle management, pharmacovigilance documentation, and regulatory compliance frameworks. The organization emphasizes quality, integrity, and timely submissions—core pillars for success in global pharmaceutical markets.

Job Role & Responsibilities

Regulatory Affairs – Officer / Executive

• Prepare and compile CTD and ACTD dossiers for ROW (Rest of World) markets
• Draft and manage query responses from regulatory authorities
• Prepare pharmacovigilance documents such as PSUR, RMP, and PSMF
• Handle opening, updating, and closing sections of Drug Master Files (DMF)
• Support BE study protocols and clinical regulatory documentation
• Develop Analytical Method Validation (AMV) protocols, reports, and chromatograms
• Prepare Nitrosamine risk assessment reports and regulatory documentation
• Develop Process Validation (PV) protocols and reports
• Manage stability study documentation and regulatory submissions
• Prepare Product Development Reports (PDR)
• Draft and review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR)
• Create SmPC leaflets, package inserts, and labeling documentation
• Support preparation and review of technical dossiers for global submissions

These responsibilities directly contribute to pharmaceutical product approvals, regulatory compliance, and global market access—making this role critical in the drug development and commercialization lifecycle.

Eligibility / Qualifications

Required Education:

• B.Pharm
• M.Pharm

Relevant Courses:

Regulatory Affairs, Pharmaceutical Analysis, Pharmaceutics, Industrial Pharmacy, Clinical Research, Pharmacovigilance, Drug Regulatory Affairs, GMP, GLP, Quality Assurance

Experience Required:

• 6 months to 3 years (ROW regulatory experience preferred)

Skills Required:

• Strong understanding of CTD/ACTD dossier structure
• Knowledge of global regulatory guidelines and submissions
• Experience with DMF, AMV, PV, and stability documentation
• Good documentation and technical writing skills
• Analytical thinking and attention to detail
• Ability to handle multiple regulatory projects simultaneously

Location & Salary

• Location: Ahmedabad, Gujarat (Bopal)
• Salary: Best in industry (based on experience and skillset)
• Preference: Local candidates and immediate joiners

Application Process

Interested candidates can apply by sharing their updated resume.

• Email: director@viharshlifescience.com
• Contact: +91 8320731621

Office Address:

Viharsh Lifescience Pvt. Ltd. Office No. 514, 5th Floor, Satyamev Elite, Opp. BRTS Junction, Bopal, Ahmedabad, Gujarat

Why Join Viharsh Lifescience?

• Work on global regulatory (ROW) projects
• Hands-on exposure to CTD dossier preparation and regulatory submissions
• Opportunity to build expertise in pharmacovigilance and compliance documentation
• Career growth in high-demand domains like Regulatory Affairs and Clinical Documentation
• Collaborative environment focused on quality and integrity

This role plays a direct part in ensuring that safe and effective medicines reach international markets through compliant regulatory pathways.

FAQs

Who can apply for this Regulatory Affairs role?

Candidates with B.Pharm or M.Pharm qualifications and 6 months to 3 years of experience.

What kind of regulatory work is involved?

CTD/ACTD dossier preparation, DMF handling, AMV, PV documents, and global submissions.

Is prior experience mandatory?

Yes, basic experience in Regulatory Affairs or related documentation is required.

Are freshers eligible?

Candidates with at least 6 months of relevant experience are preferred.

How to apply?

Send your updated CV to director@viharshlifescience.com or contact via phone.

Final Thoughts

This Viharsh Lifescience hiring opportunity is ideal for professionals looking to specialize in Regulatory Affairs, one of the highest-paying and fastest-growing domains in the pharmaceutical industry. With increasing global demand for compliance, dossier preparation, and regulatory approvals, this role provides strong exposure to high-CPC pharma skills.

If you want to build a long-term career in global pharmaceutical regulations, submissions, and compliance, this opportunity offers the right foundation.

Company	Viharsh Lifescience Pvt. Ltd.
Vacancies	Regulatory Affairs Officer, Regulatory Affairs Executive
Required Education	B.Pharm, M.Pharm
Experience	6 Months – 3 Years