Job Opportunity: Executive / Sr. Executive – Regulatory Affairs at Akums Drugs & Pharmaceuticals Ltd

Job Summary

Akums Drugs & Pharmaceuticals Ltd is seeking a detail-oriented and experienced Regulatory Affairs professional to join our team in Andheri East, Mumbai. In this role, you will be responsible for the preparation, compilation, and submission of regulatory dossiers for the ROW (Rest-of-World) markets. This position is perfect for a dedicated professional with 3–6 years of experience looking to advance their career within a leading pharmaceutical manufacturing environment by handling complex lifecycle management, MOH query responses, and cross-functional regulatory compliance.

Job Details

• Position: Executive / Sr. Executive – Regulatory Affairs
• Company: Akums Drugs & Pharmaceuticals Ltd
• Location: Andheri East, Mumbai
• Experience: 3–6 Years
• Qualification: B.Pharm / M.Pharm
• Salary Range: ₹4 – ₹5.5 LPA
• Job Type: Full-Time

Key Responsibilities

Dossier Preparation & Submission

• Prepare, compile, and thoroughly review CTD and ACTD dossiers for various ROW markets.
• Ensure that all regulatory documentation meets international standards for completeness and compliance.
• Strictly adhere to country-specific submission requirements to facilitate smooth product registration.

Query Handling & Lifecycle Management

• Proactively manage and respond to Ministry of Health (MOH) queries and deficiency letters, ensuring all responses are accurate and submitted within strict timelines.
• Oversee post-approval lifecycle activities, including variations, renewals, and product retentions.
• Maintain updated regulatory submission trackers and comprehensive archives to ensure transparency and readiness for audits.

Cross-Functional Coordination

• Collaborate effectively with internal departments, including Quality Assurance (QA), Quality Control (QC), Production, and Research & Development (R&D), to gather essential documentation.
• Ensure that all product artwork and labeling strictly comply with registered dossiers and local regulatory guidelines.

Required Skills & Expertise

Technical Competencies

• Solid understanding and application of ICH Guidelines.
• Proven hands-on experience in preparing documentation in CTD and ACTD formats.
• Technical proficiency in DMF, COA, Stability Data, and GMP documentation.
• Practical knowledge of international regulatory submission processes, specifically for ROW markets.

Functional Competencies

• Expertise in navigating regulatory authority interactions and query resolution.
• Strong organizational skills with an ability to manage regulatory databases and trackers efficiently.
• Excellent written and verbal communication skills to facilitate cross-departmental collaboration.

Eligibility Criteria

• Education: A degree in B.Pharm or M.Pharm is mandatory.
• Experience: 3–6 years of demonstrated experience in a Regulatory Affairs role.
• Preference: Candidates with a track record of managing international regulatory submissions for ROW markets will be given preference.

Why Join Akums?

Joining Akums Drugs & Pharmaceuticals Ltd means becoming part of one of India’s premier pharmaceutical companies. We offer a dynamic work environment where you will gain significant exposure to global regulatory landscapes. This role is designed to provide substantial career growth, offering you the opportunity to work alongside cross-functional experts and deepen your expertise in global regulatory compliance and lifecycle management.

How to Apply

If you meet the requirements and are eager to take the next step in your career with Akums Drugs & Pharmaceuticals Ltd, please prepare your updated resume and apply via the company’s official career portal or the designated application link. We encourage all qualified applicants to submit their applications promptly to be considered for this position.