ICPA Health Products is hiring for the position of Regulatory Affairs Officer (Factory) at its Ankleshwar, Gujarat manufacturing facility. This opportunity is suitable for B.Pharm and M.Pharm candidates with 1–4 years of relevant pharmaceutical industry experience, particularly in formulation regulatory affairs, dossier preparation, regulatory documentation and compliance.
The selected candidate will be part of the Factory Regulatory Affairs team and will coordinate with the Corporate RA team. Candidates with knowledge of ICH guidelines, CTD/ACTD dossier preparation and regulatory requirements for EU, Australia, Ukraine and UK markets are particularly relevant for this opening.
ICPA Health Products Regulatory Affairs Officer – Job Overview
| Particular | Details |
|---|---|
| Company | ICPA Health Products |
| Position | Regulatory Affairs Officer (Factory) |
| Department | Legal & Regulatory / Regulatory Affairs |
| Industry | Pharmaceutical & Life Sciences |
| Location | Ankleshwar, Gujarat |
| Experience | 1–4 Years |
| Qualification | B.Pharm / M.Pharm |
| Salary | ₹2.75–4.5 LPA |
| Openings | 1 |
| Employment Type | Full-Time, Permanent |
| Job Function | Regulatory Affairs & Compliance |
Job Responsibilities
As a Regulatory Affairs Officer at ICPA Health Products, the selected candidate will support regulatory activities at the Ankleshwar formulation manufacturing facility. Major responsibilities are expected to include:
- Prepare and manage regulatory documentation for pharmaceutical products.
- Support dossier preparation in ACTD and CTD formats.
- Ensure regulatory documents comply with applicable ICH guidelines.
- Coordinate regulatory activities between the Ankleshwar factory and Corporate Regulatory Affairs team.
- Maintain accurate regulatory documentation and compliance records.
- Support regulatory requirements for EU, Australia, Ukraine and UK markets.
- Work with formulation-related regulatory documents and manufacturing information.
- Ensure proper document management and timely availability of regulatory information.
- Communicate effectively with internal regulatory and manufacturing stakeholders.
Qualification & Eligibility
Candidates interested in the ICPA Health Products Regulatory Affairs Officer job should meet the following requirements:
Educational Qualification:
B.Pharm, particularly candidates with an Industrial Pharmacy background, and M.Pharm in Pharmacy can apply.
Experience:
Candidates should have approximately 1–4 years of relevant experience.
Important: Formulation experience is mandatory according to the provided job description.
Key Skills Required
Candidates should have knowledge or experience in:
- Regulatory Affairs
- Regulatory Compliance
- CTD Dossier Preparation
- ACTD Dossier Preparation
- ICH Guidelines
- Pharmaceutical Documentation
- Document Management
- Formulation Plant Regulatory Affairs
- EU Regulatory Requirements
- UK Regulatory Requirements
- Australia Regulatory Requirements
- Ukraine Regulatory Requirements
- Regulatory Coordination
- Communication Skills
Salary
The advertised salary range for the Regulatory Affairs Officer position at ICPA Health Products is approximately:
₹2.75 lakh – ₹4.5 lakh per annum
Final compensation may depend on the candidate’s relevant experience, current salary, regulatory expertise and company policies.
Why Consider This Regulatory Affairs Opportunity?
This position can provide relevant exposure to factory regulatory affairs and international pharmaceutical regulatory requirements. The role involves coordination with Corporate RA and work associated with multiple regulated or international markets.
Candidates may gain practical exposure to CTD/ACTD dossiers, ICH guidelines, regulatory documentation, formulation manufacturing and international regulatory requirements, making the position relevant for professionals building a career in pharmaceutical regulatory affairs.
Who Should Apply?
This opening is particularly suitable for candidates who:
- Hold a B.Pharm or M.Pharm
- Have 1–4 years of relevant experience
- Have pharmaceutical formulation experience
- Understand CTD and ACTD dossier formats
- Have knowledge of ICH guidelines
- Have experience in regulatory documentation
- Understand requirements for international pharmaceutical markets
- Can coordinate effectively between plant and corporate regulatory teams
How to Apply
