Regulatory Affairs Executive Job at Akums in Mumbai apply online for pharma dossier and ROW submission jobs IndiaPharmaJobs
Akums Drugs & Pharmaceuticals Ltd is hiring experienced professionals for the role of Executive / Senior Executive – Regulatory Affairs in Mumbai. This opportunity is well-suited for candidates with hands-on experience in dossier preparation, international regulatory submissions, and lifecycle management.
If you are looking to advance your career in regulatory affairs, particularly in ROW (Rest of World) markets, this position offers strong exposure and long-term growth in the pharmaceutical industry. Regulatory Affairs Executive Job at Akums
Company Overview
Akums Drugs & Pharmaceuticals Ltd is one of India’s leading pharmaceutical contract manufacturing organizations (CDMO), providing end-to-end solutions to domestic and international clients. The company is known for its robust manufacturing capabilities, regulatory expertise, and global presence across multiple therapeutic segments. Akums plays a key role in delivering high-quality pharmaceutical products and regulatory services worldwide. Regulatory Affairs Executive Job at Akums
Job Overview
| Job Details | Information |
|---|---|
| Company Name | Akums Drugs & Pharmaceuticals Ltd |
| Job Role | Executive / Sr. Executive – Regulatory Affairs |
| Location | Andheri East, Mumbai |
| Employment Type | Full-Time |
| Qualification | B.Pharm / M.Pharm |
| Experience | 3 – 6 Years |
| Industry | Pharmaceutical / Regulatory Affairs |
| Application Mode | Online |
| Salary | ₹4 – ₹5.5 LPA (Estimated) |
Job Location & Employment Type
- Location: Andheri East, Mumbai, Maharashtra
- Job Type: Full-Time
- Candidates should be comfortable working in a corporate regulatory environment with cross-functional teams.
Open Positions / Department Details
Executive / Senior Executive – Regulatory Affairs
The selected candidate will be responsible for managing regulatory documentation, dossier preparation, and submission activities for international markets, especially ROW regions.
Key Roles & Responsibilities
Dossier Preparation & Submission
- Prepare and compile CTD / ACTD dossiers for international submissions
- Review regulatory documents for completeness and compliance
- Ensure adherence to country-specific regulatory requirements
Query Handling & Lifecycle Management
- Respond to queries from regulatory authorities (MOH) within defined timelines
- Manage post-approval changes such as variations, renewals, and retentions
- Handle lifecycle management activities effectively
Cross-functional Coordination
- Collaborate with QA, QC, Production, and R&D teams
- Ensure labeling and artwork compliance as per approved dossiers
- Maintain submission trackers, documentation, and archives
Regulatory Affairs Executive Job at Akums
Eligibility Criteria
Education
- B.Pharm or M.Pharm (mandatory)
Experience
- 3 to 6 years of experience in regulatory affairs
- Experience in international submissions, especially ROW markets, is preferred
Skills Required
Technical Skills
- Strong knowledge of ICH guidelines
- Hands-on experience in CTD and ACTD dossier formats
- Understanding of regulatory documentation such as DMF, COA, stability data, and GMP
Functional Skills
- Experience in handling MOH queries and regulatory communications
- Strong coordination and documentation abilities
- Familiarity with regulatory databases and tracking systems
Regulatory Affairs Executive Job at Akums
Salary & Benefits
- Estimated Salary: ₹4 – ₹5.5 LPA
Additional benefits include:
- Opportunity to work with a leading pharmaceutical manufacturing company
- Exposure to global regulatory submissions and compliance practices
- Career growth in regulatory affairs and international markets
- Experience working with cross-functional pharma teams
Selection Process
The hiring process may include:
- Online application screening
- HR interview
- Technical interview focusing on regulatory knowledge
- Final selection and offer
How to Apply
Interested candidates can apply through the official online application link provided by Akums.
Ensure your resume highlights your experience in regulatory affairs, dossier preparation, and international submissions. Regulatory Affairs Executive Job at Akums
Important Dates
- Application Status: Open
- Last Date to Apply: Not specified (apply early for better chances)
Why Apply for This Pharma Job?
This role offers a valuable opportunity to work in international regulatory affairs, especially in ROW markets. It provides exposure to global submission processes, regulatory compliance, and lifecycle management, which are critical skills in the pharmaceutical industry.
Working with Akums will enhance your expertise in dossier preparation and regulatory strategy, opening doors to senior roles in regulatory affairs. Regulatory Affairs Executive Job at Akums
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Akums Drugs & Pharmaceuticals Ltd or any recruitment agency. Candidates are advised to verify all details from official sources before applying. We do not charge any fee for job applications. Regulatory Affairs Executive Job at Akums
Final Call-to-Action
If you have experience in regulatory affairs and want to grow in international submissions and compliance, this opportunity at Akums is worth applying for. Submit your application now and take the next step in your pharma career. Regulatory Affairs Executive Job at Akums
