Regulatory Affairs Executive & Manager

Regulatory Affairs Executive & Manager; Mumbai; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Healthnova Pharma in Mumbai invites applications for Regulatory Affairs Executive and Manager roles. The positions oversee EU regulatory activities across product lifecycle, from registrations to post-approval maintenance, with hands-on experience in EU dossiers and liaising with EMA and national authorities.

Applicants should hold BPharm or MPharm, with 2–5 years (Executive) or 6–10+ years (Manager) EU regulatory experience; in-depth knowledge of eCTD/NeeS formats; and ability to work

Qualifications

• 2–5 years EU regulatory experience for Regulatory Affairs Executive.
• 6–10+ years EU regulatory experience for Regulatory Affairs Manager.

Responsibilities

• Plan and manage EU regulatory strategies across the product lifecycle.
• Prepare, review, and submit dossiers via eCTD and NeeS formats.
• Coordinate submissions with EMA and EU national authorities.
• Manage variations, renewals, and post-approval changes.
• Liaise with CMOs for regulatory impact and site changes.
• Monitor EU GMP, GDP updates and regulatory intelligence.

Skills

EU regulatory experience

Education

BPharm/MPharm

MSc Life Sciences

Job description

Healthnova Pharma hiring Regulatory Affairs Executive & Manager in Mumbai. MPharm, Pharmacy graduates with EU RA experience eligible.

Healthnova Pharma Kft is hiring experienced Regulatory Affairs professionals to support its European regulatory portfolio. The company is inviting applications for Regulatory Affairs Executive and Regulatory Affairs Manager roles based in Mumbai. This opportunity is ideal for candidates with hands-on EU regulatory experience who want to work across the full lifecycle of medicinal products and contribute directly to regulatory compliance and market access in Europe.

Company Overview

Healthnova Pharma Kft is a pharmaceutical organization focused on delivering high-quality, compliant medicinal products across regulated markets. With a strong presence in European regulatory activities, the company works closely with EU CMOs, MAHs, and regulatory authorities to ensure that its product portfolio meets stringent EU legislation and compliance standards.

The organization emphasizes regulatory excellence, quality-driven operations, and strong cross-functional collaboration. Healthnova Pharma plays an important role in improving patient access to safe and effective medicines by ensuring timely approvals, lifecycle maintenance, and regulatory compliance across the European Union.

Job Role & Responsibilities

The Regulatory Affairs Executive / Regulatory Affairs Manager will manage and support EU regulatory activities throughout the product lifecycle, from new registrations to post-approval maintenance.

EU Regulatory Strategy & Submissions

• Planning and execution of EU regulatory strategies for new marketing authorization applications
• Handling line extensions, renewals, and variations (IA, IB, II)
• Preparing, reviewing, and submitting dossiers through eCTD and NeeS formats
• Managing submissions via National, DCP, MRP, and Centralised procedures
• Liaising with the European Medicines Agency and EU national competent authorities

Regulatory Lifecycle Management

• Maintaining approved dossiers throughout the product lifecycle
• Managing SmPC, PIL, and labeling updates
• Supporting PSUR and PBRER activities where applicable
• Tracking regulatory commitments and submission timelines

CMO & Partner Coordination

• Coordinating with EU CMOs for Module 3 updates and manufacturing changes
• Supporting site transfers and manufacturing variations
• Reviewing CMO documentation for regulatory impact
• Providing regulatory input for quality agreements

Variations, Renewals & Compliance

• Classifying and managing variations as per EU Variations Regulation
• Preparing and submitting marketing authorization renewals
• Handling sunset clause justifications
• Ensuring compliance during manufacturing, artwork, labeling, and supply chain changes

Authority Communication & Regulatory Intelligence

• Acting as the primary contact for EU authority queries and deficiency letters
• Coordinating clock-stop responses with QA, QP, CMOs, and internal teams
• Monitoring changes in EU GMP, GDP, EMA, and national authority guidelines
• Assessing regulatory impact on the existing product portfolio

Cross-Functional Collaboration

• Working closely with Quality Assurance, Qualified Person, Supply Chain, and Business Development teams
• Supporting regulatory input for in-licensing, out-licensing, due diligence, and product feasibility assessments

Eligibility / Qualifications

Educational Qualifications:

Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or Chemistry

Relevant courses include:
BPharm, MPharm, MSc Pharmaceutical Sciences, MSc Life Sciences, MSc Chemistry

Experience Requirements:

• Regulatory Affairs Executive: 2 to 5 years of EU regulatory experience
• Regulatory Affairs Manager: 6 to 10+ years of EU regulatory experiencespang>