Swiss Parenterals Hiring RA API Officer/Executive

BPharm/MPharm RA API Officer–Executive | Ahmedabad

Swiss Parenterals hiring RA API Officer/Executive in Ahmedabad. Requires 3–5 yrs experience with DMFs and ICH guidelines.

Swiss Parenterals Limited is hiring experienced Regulatory Affairs professionals for its API division in Ahmedabad. This role suits candidates who have hands-on experience with DMFs, global regulatory submissions, and ICH guideline interpretation.

Company Overview

Swiss Parenterals Limited is a globally recognised pharmaceutical manufacturer known for high-quality sterile and non-sterile products. With a strong API portfolio and an expanding regulatory footprint, the company works across EU, Brazil, Canada, and multiple ROW markets. The Regulatory Affairs team plays a central role in dossier development, compliance, and lifecycle management.

Job Role & Responsibilities

Officer/Executive – Regulatory Affairs (API)

Key responsibilities include:

• Preparing, compiling, and evaluating DMFs for EU, Brazil, Canada, and ROW markets.
• Applying ICH Q-series guidelines and ICH M7 principles, including structural assessment for genotoxic impurities.
• Preparing and reviewing 2.3S and 3.2S sections for API dossiers.
• Drafting and coordinating responses to regulatory queries from various Health Authorities.
• Ensuring technical accuracy and regulatory compliance of all submissions.
• Monitoring regulatory updates and applying changes to documentation.

Eligibility / Qualifications

• B.Pharm / M.Pharm (mandatory).
• 3–5 years of experience in API Regulatory Affairs.
• Strong understanding of DMF structures, submission formats, and global regulatory expectations.
• Knowledge in genotoxic impurity risk assessment and nitrosamine-related regulatory requirements.

Relevant courses: Pharmaceutics, Industrial Pharmacy, Pharmaceutical Chemistry, Regulatory Affairs, Quality Assurance, API Technology.

Note: Freshers are not eligible.

Location & Salary

• Location: Sindhu Bhavan, Ahmedabad.
• Salary: Competitive, aligned with experience and technical competency.

Application Process

Interested candidates may share their CV at:
hroffice1@swiss.in

FAQs

1. Are freshers eligible?
No. Only candidates with 3–5 years of API RA experience are considered.

2. What regions will the submissions cover?
EU, Brazil, Canada, and ROW markets.

3. What technical skills are essential?
DMF compilation, ICH Q guidelines, ICH M7, genotoxic impurity assessment, nitrosamine knowledge.

4. Will I work on query responses?
Yes, responding to MoH queries is a key part of the role.

5. Is API experience mandatory?
Yes. API dossier and DMF experience are required.

Summary Table