Regulatory Affairs Officer Job at Icpa Health in Ankleshwar. Apply online for plant RA role with CTD dossier experience opportunity.
Introduction
Candidates aiming to establish a solid career in Regulatory Affairs within pharmaceutical manufacturing can explore this promising opportunity. Icpa Health Products is hiring Regulatory Affairs Officers for its Ankleshwar facility. This role is particularly suitable for professionals with formulation experience and exposure to global regulatory standards.
Company Overview
Icpa Health Products is a recognized pharmaceutical company known for its focus on quality formulations and compliance-driven manufacturing practices. The organization operates across multiple therapeutic segments and maintains a strong presence in both domestic and international markets.
Job Location & Employment Type
- Location: Ankleshwar, Gujarat, India
- Job Type: Full-Time, Permanent
- Industry: Pharmaceutical Manufacturing / Regulatory Affairs
Job Overview (Job Details Table)
| Job Title | Regulatory Affairs Officer (Plant RA) |
|---|---|
| Company Name | Icpa Health Products |
| Qualification | B.Pharm / M.Pharm |
| Experience | 1 – 4 Years |
| Job Location | Ankleshwar, Gujarat |
| Employment Type | Full-Time |
| Salary | ₹2.5 LPA – ₹4.5 LPA |
| Application Mode | Online Application |
| Department | Regulatory Affairs / Compliance |
| Open Positions | 4 |
Open Positions / Department Details
The hiring is within the Regulatory Affairs (Plant RA) Department, where selected candidates will handle dossier preparation, regulatory submissions, and compliance activities linked to manufacturing operations. The role involves coordination with multiple internal teams including QA, Production, and R&D.
Key Roles & Responsibilities
As a Regulatory Affairs Officer, your day-to-day responsibilities will include:
- Preparing and submitting regulatory dossiers in CTD and ACTD formats
- Ensuring compliance with ICH guidelines and international regulatory standards
- Handling regulatory requirements for global markets such as:
- European Union (EU)
- United Kingdom (UK)
- Australia
- Ukraine
- Managing lifecycle activities related to regulatory submissions
- Maintaining accurate documentation and regulatory records
- Working with document management systems (DMS)
- Coordinating with internal departments for plant-level regulatory activities
- Supporting regulatory audits and inspections
- Ensuring timely updates and compliance with evolving regulatory requirements
Eligibility Criteria
Educational Qualification
- B.Pharm (Mandatory)
- M.Pharm (Preferred)
Experience Required
- 1 to 4 years of experience in Regulatory Affairs (Plant/Manufacturing)
- Experience with formulation-based products is mandatory
Skills Required
- Strong knowledge of CTD / ACTD dossier preparation
- Understanding of ICH guidelines
- Exposure to international regulatory frameworks (EU, UK, Australia, etc.)
- Experience in regulatory submission lifecycle management
- Good documentation and communication skills
- Ability to coordinate with cross-functional teams
Salary & Benefits
- Estimated Salary: ₹2.5 LPA – ₹4.5 LPA
- Opportunity to work on global regulatory submissions
- Hands-on experience in plant-based regulatory operations
- Exposure to international pharmaceutical markets
- Career growth in Regulatory Affairs domain
- Learning opportunities in compliance strategy and dossier management
Selection Process
The recruitment process is expected to include:
- Online Application Screening
- Technical Interview (Regulatory Affairs Focus)
- HR Interview
- Final Selection
Candidates with strong dossier preparation experience and global regulatory exposure will have an advantage.
How to Apply
Interested candidates can apply through the official online application link provided by the company.
Ensure your application highlights:
- Experience in dossier preparation (CTD/ACTD)
- Knowledge of ICH guidelines
- Exposure to international regulatory markets
Important Dates
- Application Deadline: Not specified (apply as early as possible)
Why Apply for This Pharma Job?
This role offers excellent exposure for professionals aiming to grow in Regulatory Affairs:
- Work on international regulatory submissions
- Gain practical experience in plant-level RA operations
- Build expertise in global compliance standards
- Collaborate with QA, Production, and R&D teams
- Strengthen career prospects in global pharmaceutical markets
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with any company or recruiter. Candidates are advised to verify all details independently before applying. We do not charge any fee for job applications.
Final Call-to-Action
If you have experience in Regulatory Affairs and want to grow in the global pharmaceutical compliance domain, apply online at the earliest. This opportunity at Icpa Health Products can be a strong step toward building a successful career in international regulatory affairs.
