Unison Hiring Regulatory Affairs

B.Pharm/M.Pharm RA Jobs 3–6 Yrs | Ahmedabad | Unison Pharma

Unison Pharmaceuticals hiring Regulatory Affairs professionals with 3–6 years experience. B.Pharm/M.Pharm eligible. Ahmedabad location.

Unison Pharmaceuticals Pvt. Ltd. is expanding its Regulatory Affairs team and is inviting applications from experienced RA professionals looking to build long-term careers in international pharmaceutical regulatory submissions. This opportunity is ideal for candidates with hands-on exposure to EMB and ROW markets who want to work in a regulated, growth-oriented pharma organization based in Ahmedabad.

Company Overview

Unison Pharmaceuticals Pvt. Ltd. is a well-established Indian pharmaceutical company with a strong presence across regulated and semi-regulated global markets. Known for its focus on quality-driven formulations and robust regulatory compliance, Unison has built a reputation for delivering affordable and effective medicines across emerging and rest-of-world markets. The company follows stringent quality systems and maintains a professional work culture that supports continuous learning and regulatory excellence.

Job Role & Responsibilities

As part of the Regulatory Affairs team, the selected professional will be responsible for managing end-to-end regulatory activities for EMB and ROW markets. The role involves close coordination with internal teams to ensure timely submissions, approvals, and lifecycle management.

Key Responsibilities

• Preparation, review, and submission of regulatory dossiers for EMB and ROW markets
• Handling regulatory queries, deficiency responses, and approval follow-ups
• Lifecycle management activities including variations, renewals, and post-approval changes
• Coordination with QA, QC, R&D, and manufacturing teams for documentation support
• Ensuring compliance with country-specific regulatory guidelines and timelines
• Supporting product registrations across LATAM, Asia, and other ROW regions

Eligibility / Qualifications

Candidates must meet the following criteria to be considered for this role:

Educational Qualification

B.Pharm, M.Pharm

Experience

• 3 to 6 years of relevant Regulatory Affairs experience
• Mandatory exposure to EMB and ROW market submissions
• Experience exclusively in Regulatory Affairs is required; candidates from other departments will not be considered

Preferred Profile

• Strong understanding of international regulatory guidelines
• Good documentation and dossier compilation skills
• Ability to work independently on assigned markets

Location & Work Schedule

• Job Location: Vastrapur, Ahmedabad
• Local candidates preferred
• Work Schedule: 2nd & 4th Saturday off

Application Process

Interested and eligible candidates can apply directly by sharing their updated CV via email:

📧 maitrivakil@unisonpharmaceuticals.com

Please ensure your resume clearly highlights your Regulatory Affairs experience in EMB and ROW markets.

FAQs

Q1. Who can apply for this Regulatory Affairs position?
Candidates with 3–6 years of experience in Regulatory Affairs and a B.Pharm or M.Pharm qualification.

Q2. Are candidates from QA or QC eligible?
No. Only candidates with core Regulatory Affairs experience will be considered.

Q3. Which markets will this role handle?
Primarily EMB and ROW markets, including LATAM and Asia.

Q4. Is this a work-from-office role?
Yes. The position is based at the Ahmedabad office.

Summary Table

Company	Unison Pharmaceuticals Pvt. Ltd.
Vacancies	Regulatory Affairs Professionals
Required Education	B.Pharm, M.Pharm
Experience	3–6 Years