Are you an experienced Regulatory Affairs professional looking to advance your career in the pharmaceutical industry? Acme Generics is currently hiring Regulatory Affairs Executive and Senior Executive professionals for its Ahmedabad location. This opportunity is ideal for candidates with experience in EU regulatory submissions, eCTD dossier preparation, lifecycle management, and pharmaceutical regulatory compliance.

Professionals with expertise in EU Market Regulatory Affairs, pharmaceutical dossier submissions, eCTD publishing, variations, renewals, and regulatory documentation are encouraged to apply.

Regulatory Affairs Executive Job Overview

Key Responsibilities

The selected candidates will be responsible for managing regulatory affairs activities related to the European pharmaceutical market.

Regulatory Submission Activities

• Preparation, review, and submission of pharmaceutical dossiers in eCTD and NeeS formats.
• Compilation and review of Modules 1 to 5 of CTD dossiers.
• Coordination of EU regulatory submissions and approvals.
• Management of regulatory databases and submission tracking systems.

Lifecycle Management

• Handling regulatory variations and post-approval changes.
• Managing renewal applications.
• Preparation and submission of responses to deficiency queries.
• PSUR and PBRER submissions.
• Support for CBE-30, CBE-0, and PAS filings to regulatory authorities.

Cross-Functional Collaboration

• Working closely with R&D, QA, QC, Production, and Packaging teams.
• Reviewing SmPC, PIL, labeling artworks, and packaging materials.
• Ensuring compliance with EU pharmaceutical regulations.
• Supporting regulatory audits and inspections.

Regulatory Compliance

• Monitoring updates to EU regulatory guidelines.
• Ensuring ongoing compliance with EMA and country-specific requirements.
• Communicating with European agents, partners, and health authorities.
• Supporting DCP and MRP regulatory procedures.

Required Skills

Candidates applying for this Regulatory Affairs Executive job in Ahmedabad should possess:

• Strong knowledge of EU regulatory guidelines and procedures.
• Experience in eCTD publishing and dossier submissions.
• Understanding of pharmaceutical formulation dossiers.
• Knowledge of lifecycle management activities.
• Strong documentation and communication skills.
• Ability to manage multiple regulatory projects simultaneously.
• Experience with EU country submissions and regulatory tracking.

Educational Qualification

Applicants must possess one of the following qualifications:

• Bachelor of Pharmacy (B.Pharm)
• Master of Pharmacy (M.Pharm)

Experience Required

• Minimum: 3 years
• Maximum: 10 years
• Relevant experience in Regulatory Affairs for EU Markets is mandatory.

Preferred Candidate Profile

Candidates with the following experience will receive preference:

• EU Regulatory Affairs experience in OSD or Injectable products.
• Experience with Decentralized Procedure (DCP).
• Experience with Mutual Recognition Procedure (MRP).
• Exposure to multiple European country submissions.
• Expertise in pharmaceutical lifecycle management.

Why Join Acme Generics?

• Opportunity to work on global pharmaceutical regulatory projects.
• Exposure to European regulatory submissions.
• Career growth in international regulatory affairs.
• Collaborative work environment.
• Hands-on experience with EU market compliance and lifecycle management.

Salary Information

Based on industry standards for Ahmedabad pharmaceutical regulatory affairs positions:

Estimated Salary Range: ₹6,00,000 – ₹18,00,000 per annum (depending on experience, expertise, and current compensation).

How to Apply

Interested candidates can share their updated resume directly with the recruitment team.

Email: pratik.joshi@acmegenerics.in

Applicants should mention “Regulatory Affairs Executive – EU Market” in the email subject line for faster processing.