USV Hiring Regulatory Affairs Executive

USV Pharma MSc MPharm RA Executive Jobs Mumbai

MSc, MPharm Regulatory Affairs Executive vacancies at USV Pharma Mumbai for API, US and ROW markets with 2–5 years experience.

USV Pharma has announced new career opportunities for experienced professionals in Regulatory Affairs (RA) for its Mumbai operations. The company is currently hiring Regulatory Affairs Executives across multiple regulatory domains including API regulatory affairs, US market submissions, and ROW (Rest of World) regulatory submissions. These positions are based at the company’s office in Govandi (East), Mumbai.

Regulatory Affairs professionals play a critical role in the pharmaceutical industry. They ensure that medicines, APIs, and healthcare products comply with international regulatory standards before entering global markets. Pharmaceutical companies rely heavily on RA specialists to prepare regulatory submissions, manage Drug Master File (DMF) filings, Common Technical Document (CTD/eCTD) submissions, Chemistry Manufacturing Controls (CMC) documentation, and handle regulatory queries from global health authorities.

USV Pharma is seeking candidates with M.Sc and M.Pharm qualifications who possess experience in regulatory documentation, dossier preparation, global regulatory submissions, and pharmaceutical compliance processes. The roles involve handling regulatory activities for USFDA, international regulatory authorities, and global pharmaceutical markets.

For professionals aiming to build long-term careers in pharmaceutical regulatory affairs, drug approval processes, international pharmaceutical compliance, and regulatory documentation, this opportunity offers exposure to global regulatory environments and advanced pharmaceutical submission systems.

Company Overview

USV Pharma is one of India’s leading pharmaceutical companies with a strong reputation in developing and manufacturing high‑quality pharmaceutical formulations and active pharmaceutical ingredients (APIs). The company has built a strong presence in domestic and international pharmaceutical markets through innovation, quality manufacturing, and regulatory compliance.

USV operates globally across several therapeutic segments and provides pharmaceutical products to healthcare markets worldwide. The company’s manufacturing facilities follow strict international quality standards and comply with regulatory agencies such as:

• USFDA (United States Food and Drug Administration)
• EMA (European Medicines Agency)
• WHO‑GMP regulatory standards
• ICH global regulatory guidelines

USV Pharma is known for maintaining strong compliance frameworks across its research, manufacturing, and regulatory operations. The company’s regulatory affairs teams are responsible for managing pharmaceutical submissions, maintaining global regulatory approvals, and ensuring compliance with international pharmaceutical regulations.

Working at USV Pharma provides professionals exposure to global pharmaceutical regulatory submissions, advanced drug approval processes, and international regulatory compliance frameworks.

Professionals joining the regulatory affairs department will gain experience working with CTD and eCTD submissions, DMF filings, regulatory lifecycle management, global dossier submissions, and post‑approval regulatory maintenance activities.

Job Role & Responsibilities

USV Pharma is hiring Regulatory Affairs professionals for three specialized roles within the RA team.

API Regulatory Affairs Executive

This role focuses on regulatory activities related to Active Pharmaceutical Ingredients (APIs) and global API documentation.

Key responsibilities include:

• Review and verification of API regulatory documentation
• Preparation and submission of Drug Master Files (DMF)
• Managing regulatory documentation related to CMC sections
• Ensuring regulatory compliance with international guidelines
• Supporting API regulatory lifecycle management

API regulatory professionals ensure that raw pharmaceutical ingredients meet global regulatory requirements before they are used in drug formulations.

Regulatory Affairs Executive – ROW Markets

This role focuses on regulatory submissions for Rest of World (ROW) pharmaceutical markets, including emerging and regulated global markets.

Key responsibilities include:

• Preparation and compilation of regulatory dossiers
• Handling regulatory submissions for international markets
• Managing pre‑approval and post‑approval regulatory activities
• Maintaining regulatory documentation and submission timelines
• Preparing CMC sections for pharmaceutical dossiers

Professionals working in ROW regulatory affairs must understand regulatory frameworks across multiple international markets.

Regulatory Affairs Executive – US Markets

This role focuses on regulatory submissions for the United States pharmaceutical market.

Key responsibilities include:

• Preparing and submitting regulatory dossiers for US regulatory authorities
• Managing regulatory lifecycle activities for US products
• Handling pre‑approval and post‑approval regulatory submissions
• Preparing CMC documentation for regulatory filings
• Supporting regulatory query responses and documentation updates

Regulatory affairs professionals working in the US market must maintain strict compliance with USFDA regulatory guidelines and ICH regulatory standards.

Eligibility / Qualifications

USV Pharma is seeking professionals with academic backgrounds in pharmaceutical sciences and regulatory affairs.

Required Educational Qualifications

M.Sc, M.Pharm

Relevant specializations include:

Pharmaceutical Sciences, Pharmaceutical Chemistry, Pharmaceutical Analysis, Regulatory Affairs, Pharmaceutical Technology, Life Sciences

These programs provide candidates with knowledge in drug development processes, pharmaceutical regulatory guidelines, pharmaceutical documentation, and global regulatory submission standards.

Experience Requirements

API Regulatory Affairs Executive

• Minimum 2.5 years experience in API Regulatory Affairs

ROW Markets Regulatory Affairs Executive

• Minimum 5 years experience in Regulatory Affairs for ROW markets

US Markets Regulatory Affairs Executive

• Minimum 2 years experience in Regulatory Affairs for US markets

Candidates must have hands‑on experience with regulatory documentation review, dossier preparation, DMF filings, and CMC regulatory documentation.

Required Skills

Ideal candidates should possess:

• Strong knowledge of global pharmaceutical regulatory guidelines
• Experience with CTD/eCTD dossier submissions
• Expertise in CMC documentation
• Understanding of regulatory lifecycle management
• Strong documentation and regulatory writing skills

Professionals with experience handling USFDA regulatory submissions, international regulatory dossiers, or API regulatory compliance will be preferred.

Location & Salary

Job Location

USV Pharma

Govandi (East), Mumbai

Mumbai is one of India’s largest pharmaceutical and biotechnology hubs with several global pharmaceutical companies and regulatory consulting organizations operating in the region.

Work Schedule

• 5‑day work week
• 2nd and 4th Saturdays off

Salary

Salary packages will be offered based on candidate experience, qualifications, and industry standards. Regulatory affairs professionals in pharmaceutical companies typically receive competitive compensation along with long‑term career growth opportunities.

Application Process

Interested candidates who meet the eligibility criteria can apply by sending their updated resume.

Send your CV to:

priyanka.n.raotole@usv.in

Applicants should include the following details when applying:

• Full name
• Educational qualifications
• Total regulatory affairs experience
• Current company and designation
• Notice period availability

Shortlisted candidates will be contacted by the HR team for further interview rounds.

Why Choose a Career in Pharmaceutical Regulatory Affairs

Regulatory Affairs is one of the most important functions in the pharmaceutical industry. Without regulatory approvals, pharmaceutical products cannot enter global markets. Regulatory professionals ensure that medicines meet strict safety, quality, and efficacy standards set by international health authorities.

Professionals working in regulatory affairs gain expertise in areas such as:

• Drug approval processes
• Global pharmaceutical regulatory guidelines
• Regulatory dossier preparation
• Drug Master File (DMF) submissions
• Pharmaceutical lifecycle management

These skills are highly valued across the pharmaceutical sector including:

• Pharmaceutical manufacturing companies
• Contract research organizations (CROs)
• Regulatory consulting firms
• Biotechnology companies
• Global pharmaceutical regulatory agencies

Career progression opportunities include:

• Senior Regulatory Affairs Manager
• Global Regulatory Strategy Specialist
• Regulatory Compliance Director
• Pharmaceutical Regulatory Consultant

Professionals working in regulatory affairs contribute directly to the availability of safe and effective medicines across global healthcare systems.

Frequently Asked Questions (FAQs)

Who can apply for the USV Pharma Regulatory Affairs roles?

Candidates with M.Sc or M.Pharm qualifications and relevant regulatory affairs experience can apply.

What roles are currently available?

USV Pharma is hiring Regulatory Affairs Executives for API, US market, and ROW market regulatory submissions.

Where is the job located?

The position is based at the USV Pharma office in Govandi (East), Mumbai.

What regulatory skills are required?

Candidates should have knowledge of DMF filing, CMC documentation, CTD/eCTD submissions, and pharmaceutical regulatory guidelines.

How can candidates apply?

Candidates can send their updated resume to the official HR email mentioned in the job posting.

Job Summary

Company	USV Pharma
Vacancies	Regulatory Affairs Executive – API / US Markets / ROW Markets
Required Education	M.Sc, M.Pharm
Experience	2 – 5 Years