Regulatory Affairs Executive Job at Akums in Mumbai. B.Pharm/M.Pharm candidates with 3–6 years experience in CTD, ACTD, and ROW submissions apply now.
Company Overview
Akums Drugs & Pharmaceuticals Ltd is one of India’s leading pharmaceutical contract manufacturing organizations, known for its large-scale production capabilities and global presence. The company specializes in formulations, regulatory services, and international market expansion. With a strong reputation in quality and compliance, Akums offers excellent career opportunities in regulatory affairs and pharmaceutical operations.
Job Overview
| Job Title | Regulatory Affairs Executive / Sr. Executive |
|---|---|
| Company | Akums Drugs & Pharmaceuticals Ltd |
| Location | Andheri East, Mumbai |
| Employment Type | Full-Time |
| Experience | 3–6 Years |
| Qualification | B.Pharm / M.Pharm |
| Department | Regulatory Affairs |
| Salary | ₹4 – ₹5.5 LPA |
| Job Type | Permanent |
Job Location & Employment Type
- Location: Andheri East, Mumbai
- Employment Type: Full-time
- Work Mode: Office-based
Open Position / Department Details
This role is part of the Regulatory Affairs team, responsible for managing global dossier submissions, compliance activities, and lifecycle management for pharmaceutical products. The position focuses on ROW (Rest of World) markets, offering hands-on exposure to international regulatory processes.
Key Roles & Responsibilities
Dossier Preparation & Submission
- Prepare and compile CTD / ACTD dossiers for international markets
- Ensure regulatory documents meet compliance and submission standards
- Manage country-specific submission requirements
Query Handling & Lifecycle Management
- Respond to MOH (Ministry of Health) queries and deficiency letters
- Handle post-approval changes, including variations and renewals
- Maintain lifecycle activities as per regulatory timelines
Cross-Functional Coordination
- Collaborate with QA, QC, Production, and R&D teams for documentation
- Ensure compliance in artwork and labeling as per approved dossiers
- Maintain regulatory trackers, databases, and archives
Eligibility Criteria
Education
- B.Pharm or M.Pharm (Mandatory)
Experience
- 3 to 6 years of experience in Regulatory Affairs
- Experience in ROW market submissions preferred
Skills Required
Technical Skills:
- Strong knowledge of ICH Guidelines
- Hands-on experience with CTD and ACTD formats
- Understanding of DMF, COA, Stability Data, and GMP documentation
Functional Skills:
- Experience in handling MOH queries and regulatory authority communication
- Strong documentation and coordination abilities
- Familiarity with regulatory databases and submission tracking systems
Core Competencies:
- Attention to detail and regulatory compliance mindset
- Ability to manage multiple submissions and deadlines
- Effective communication and teamwork skills
Salary & Benefits
- Salary: ₹4 – ₹5.5 LPA (Expected Range)
- Additional benefits as per company norms
Selection Process
The hiring process may include:
- Resume screening
- Technical interview (Regulatory Affairs)
- HR discussion
- Final selection
How to Apply
Interested candidates can apply through the official application link provided by the company.
Important Dates
- Application Deadline: Not specified (apply early)
Why Apply for This Pharma Job?
- Work with a leading Indian pharmaceutical manufacturing company
- Gain exposure to global regulatory submissions (ROW markets)
- Hands-on experience in CTD/ACTD dossier preparation and lifecycle management
- Strong career growth in Regulatory Affairs and Compliance
- Opportunity to collaborate with multiple pharma departments
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Akums Drugs & Pharmaceuticals Ltd or any recruiter. We do not charge any fee for job postings or applications. Candidates are advised to verify details from the official company website before applying.
Final Call-to-Action
If you have experience in regulatory affairs and want to advance your career in global submissions and compliance, this is a great opportunity. Apply now and take your pharma career forward with Akums.
