"Regulatory Affairs Officer Job in Ankleshwar | Icpa Health Products Ltd Hiring B.Pharm/M.Pharm (1–4 Years Exp)"
Regulatory Affairs Officer Job in Ankleshwar – Icpa Health Products Ltd Hiring (Plant RA)
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(Regulatory Affairs Officer Job in Ankleshwar) |
Introduction
Are you searching for a Regulatory Affairs Officer job in Ankleshwar, Gujarat? Icpa Health Products Ltd has announced exciting openings for Plant Regulatory Affairs professionals with formulation experience and expertise in global regulatory markets such as the EU, UK, Australia, and Ukraine.
This Pharmaceutical Regulatory Affairs job is ideal for B.Pharm and M.Pharm candidates who have 1–4 years of experience in dossier preparation, CTD/ACTD documentation, and ICH guideline compliance. If you are looking to build a strong career in global regulatory submissions and plant-level regulatory compliance, this opportunity can be a valuable step forward.
About The Company
Icpa Health Products Ltd is a well-established Indian pharmaceutical company founded in 1972. The company is headquartered in Mumbai, Maharashtra, India, and has a strong manufacturing presence in Ankleshwar, Gujarat.
Icpa is a leading name in the Indian oral healthcare segment, offering a wide portfolio of dental care and pharmaceutical products. Over the years, the company has built a strong reputation for quality manufacturing, regulatory compliance, and innovation in oral healthcare solutions.
Icpa operates across India with a wide distribution network and employs more than 1,000+ professionals across manufacturing, quality assurance, regulatory affairs, research & development, and marketing departments. The company continues to expand its presence in international markets, focusing on regulatory approvals in the EU, UK, Australia, and other global regions.
Job Overview Summary
The Regulatory Affairs Officer (Plant RA) role at Icpa Health Products Ltd is focused on managing plant-level regulatory documentation and supporting global market submissions.
The selected candidate will handle CTD and ACTD dossier preparation, ensure compliance with ICH guidelines, coordinate regulatory submissions, and maintain documentation systems. This position requires strong knowledge of formulation-based regulatory documentation and experience in handling international regulatory standards.
Immediate joiners with relevant Plant Regulatory Affairs experience will be given preference.
Vacancy Details (Official Information)
Position: Regulatory Affairs Officer (Plant RA)
Company: Icpa Health Products Ltd
Location: Ankleshwar, Gujarat
Experience Required: 1–4 Years
Qualification: B.Pharm (Mandatory), M.Pharm (Preferred)
Industry: Pharmaceutical & Life Sciences
Employment Type: Full-Time, Permanent
Openings: 3
Salary: ₹2.5 – ₹4.5 LPA (Approx.)
Responsibility Explanation (Detailed)
The Regulatory Affairs Officer will play an important role in ensuring that pharmaceutical products manufactured at the plant meet international regulatory standards.
Key responsibilities include:
• Preparing and compiling regulatory dossiers in CTD (Common Technical Document) and ACTD formats
• Managing regulatory documentation for international markets, including the EU, UK, Australia, and Ukraine
• Ensuring strict compliance with ICH guidelines and international regulatory frameworks
• Supporting regulatory submissions and post-approval lifecycle management activities
• Maintaining plant-level documentation control systems
• Coordinating with QA, QC, and Production departments for compliance-related documentation
• Supporting regulatory audits and inspections
• Ensuring timely renewal and variation submissions
This role demands close attention to detail, documentation accuracy, and strong knowledge of pharmaceutical regulatory guidelines.
Eligibility Criteria (Official)
UG: B.Pharm (Mandatory)
PG: M.Pharm (Preferred)
Experience: 1–4 years in Regulatory Affairs (Plant RA)
Mandatory Requirement: Formulation experience
Strong knowledge required in:
CTD & ACTD Dossier Preparation
EU & UK Regulatory Requirements
ICH Guidelines
Regulatory Documentation & Submissions
Skills Required (Expanded)
Candidates applying for this Pharma Regulatory Affairs job should possess:
• Strong understanding of global regulatory guidelines
• Expertise in CTD documentation structure
• Hands-on experience in dossier compilation
• Knowledge of plant regulatory compliance procedures
• Good documentation and record management skills
• Strong coordination skills with cross-functional teams
• Ability to handle regulatory audits
• Effective written and verbal communication skills
Salary Estimate
The offered salary range is ₹2.5 – ₹4.5 LPA, depending onthe candidate's experience and regulatory exposure.
Fresh RA professionals (1 year experience) may start at ₹2.5–3 LPA, while candidates with strong EU/UK dossier experience and 3–4 years of experience may negotiate closer to ₹4.5 LPA.
International market exposure significantly improves salary negotiation potential.
Interview Details (Official Process)
Application Mode: Online through Naukri Portal
Shortlisting: Based on qualification and Plant RA experience
Interview Rounds: HR Round + Technical Regulatory Round + Final Discussion
Immediate joiners may be preferred during final selection
Required Documents
Candidates should keep the following documents ready:
Updated Resume with detailed RA experience
Educational Certificates (B.Pharm / M.Pharm)
Experience Letters
Salary Slips (if required)
CTD/ACTD dossier exposure details
Government ID proof
Location
Job Location: Ankleshwar, Gujarat
Ankleshwar is one of India’s largest pharmaceutical manufacturing hubs with multiple API and formulation companies operating in the region.
Apply Method
Interested candidates can apply online via the official job listing portal:
Application Link:
Candidates are advised to apply early, as only 3 openings are available.
Frequently Asked Questions (FAQs)
Q1. Is formulation experience mandatory?
Yes, formulation experience is mandatory for this Plant Regulatory Affairs role.
Q2. What is the required experience for this job?
Candidates must have 1–4 years of experience in Regulatory Affairs.
Q3. Is M.Pharm compulsory?
No, B.Pharm is mandatory. M.Pharm is preferred but not compulsory.
Q4. Which markets are handled in this role?
EU, UK, Australia, and Ukraine regulatory markets.
Q5. What is the job location?
Ankleshwar, Gujarat.
Final Conclusion
The Regulatory Affairs Officer (Plant RA) position at Icpa Health Products Ltd offers a strong opportunity for early-career regulatory professionals to gain exposure in global pharmaceutical markets.
With responsibilities in CTD dossier preparation, international regulatory submissions, and plant-level compliance management, this role is suitable for candidates looking to build a long-term career in pharmaceutical regulatory affairs.
If you have strong knowledge of ICH guidelines and global submission formats, this opportunity in Ankleshwar’s pharmaceutical hub can significantly strengthen your professional profile.
Note: Pharma Duniya does not charge any money for job information.
Candidates are advised to verify details from the official company website.
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