Swiss Parenteral Limited hiring Regulatory Affairs Executive to Assistant Manager in Ahmedabad. Apply now for CTD, ACTD, eCTD dossier roles.
Company: Swiss Parenteral Limited (Swiss Pharma)
Position: Regulatory Affairs – Executive to Assistant Manager
Location: Sindhu Bhavan, Ahmedabad, Gujarat
Qualification Required: B.Pharm / M.Pharm
Experience Required: 3–8 Years
Job Type: Full-time
Application Mode: Email Application
Job Verification: Verified Job
About Swiss Parenteral Limited
Swiss Parenteral Limited, also known as Swiss Pharma, is one of India’s leading pharmaceutical manufacturers specializing in parenteral and injectable formulations. With a strong presence in both domestic and international markets, Swiss Parenteral is recognized for its commitment to quality, compliance, and patient safety. Swiss Parenteral Limited Hiring for Regulatory Affairs Job
The company manufactures and exports a wide range of sterile injectable products catering to Africa, LATAM, MENA, APAC, and other ROW (Rest of the World) markets. Swiss Parenteral operates with advanced manufacturing facilities and adheres strictly to international standards such as WHO-GMP, ISO, and ICH guidelines. Swiss Parenteral Limited Hiring for Regulatory Affairs Job
As part of its expansion in international markets, Swiss Parenteral Limited is inviting qualified professionals to join its Regulatory Affairs team at its corporate office in Sindhu Bhavan, Ahmedabad. The company is currently hiring for Executive to Assistant Manager positions within the Regulatory Affairs department. Swiss Parenteral Limited Hiring for Regulatory Affairs Job
This is a prime opportunity for professionals with experience in CTD, ACTD, eCTD, and dossier preparation who want to work in a globally recognized pharmaceutical organization.
Job Overview
| Position Title | Regulatory Affairs – Executive to Assistant Manager |
|---|---|
| Company | Swiss Parenteral Limited |
| Department | Regulatory Affairs |
| Location | Sindhu Bhavan, Ahmedabad, Gujarat |
| Qualification | B.Pharm or M.Pharm |
| Experience Required | 3 – 8 Years |
| Job Type | Full-time |
| Application Mode | Email Application |
| Salary Range | ₹5,00,000 – ₹10,00,000 per annum |
| Last Date to Apply | November 4, 2025 |
About the Role
The Regulatory Affairs (RA) Executive / Assistant Manager plays a crucial role in ensuring compliance with international regulatory requirements and supporting global market registrations for parenteral products. Swiss Parenteral Limited Hiring for Regulatory Affairs Job
The role demands in-depth knowledge of Common Technical Document (CTD), ASEAN Common Technical Dossier (ACTD), electronic CTD (eCTD), and experience in dossier preparation and submission for regulated and semi-regulated markets such as Africa, LATAM, MENA, and APAC.
If you are a pharmaceutical professional with 3–8 years of core regulatory experience and are looking for a challenging yet rewarding opportunity, this position at Swiss Parenteral Limited offers significant growth potential and international exposure.
Key Responsibilities
As part of the Regulatory Affairs team, your responsibilities will include the preparation, review, and management of regulatory submissions for multiple global markets. The role also involves close collaboration with cross-functional teams including R&D, QA/QC, Production, and Packaging departments to ensure regulatory compliance. Swiss Parenteral Limited Hiring for Regulatory Affairs Job
1. Dossier Preparation and Compilation
- Prepare, compile, and review regulatory dossiers in CTD, ACTD, and eCTD formats.
- Ensure completeness and accuracy of documents for submission to health authorities.
- Coordinate with technical teams to gather required data for dossier compilation.
- Maintain version control and documentation integrity during the dossier preparation process.
2. Regulatory Submissions
- Submit registration dossiers for ROW markets, focusing on Africa, LATAM, MENA, and APAC regions.
- Track submission status, respond to health authority queries, and ensure timely approvals.
- Prepare variation applications, renewals, and post-approval documentation as per regulatory requirements.
3. Compliance and Documentation
- Ensure that all submissions comply with international regulatory guidelines and ICH standards.
- Maintain and update internal databases for product registrations and renewals.
- Support internal and external audits by providing regulatory documentation.
- Collaborate with QA and Production teams to address compliance-related observations.
4. Market and Regulatory Intelligence
- Stay updated with evolving regulatory requirements across target markets.
- Monitor changes in guidelines from agencies like WHO, GCC, and regional health authorities.
- Communicate regulatory updates to internal stakeholders to align operations with new requirements.
5. Coordination and Cross-functional Support
- Work closely with formulation, analytical, and packaging development teams to ensure alignment with regulatory needs.
- Provide technical support during product development and variation filings.
- Support marketing and business development teams by providing regulatory inputs for new market launches.
Qualifications and Experience
| Criteria | Details |
|---|---|
| Educational Qualification | B.Pharm or M.Pharm from a recognized university/institution |
| Experience Required | 3–8 years in Regulatory Affairs within a pharmaceutical company |
| Core Expertise | CTD, ACTD, eCTD dossier preparation and review |
| Product Type | Parenteral / Injectable formulations |
| Market Exposure | Africa, LATAM, MENA, APAC regions |
| Computer Proficiency | MS Office, Document Management Systems, Regulatory software tools |
| Language Skills | Excellent written and verbal English communication |
Note: Freshers are not eligible for this position.
Key Skills Required
To succeed in this role, candidates must possess the following competencies: Swiss Parenteral Limited Hiring for Regulatory Affairs Job
- Strong understanding of global regulatory submission processes.
- In-depth knowledge of dossier formats (CTD, ACTD, eCTD).
- Ability to interpret and implement international regulatory guidelines.
- Strong organizational and documentation skills.
- Effective communication and coordination with cross-functional departments.
- Detail-oriented with excellent time management.
- Experience with parenteral products will be an added advantage.
Salary and Compensation
| Position Level | Experience Range | Annual Salary (Approx.) |
|---|---|---|
| Executive | 3 – 5 years | ₹5,00,000 – ₹7,00,000 per annum |
| Assistant Manager | 6 – 8 years | ₹7,00,000 – ₹10,00,000 per annum |
The final offer will depend on the candidate’s experience, expertise, and current compensation structure.
Swiss Parenteral Limited provides a competitive salary package, along with career progression opportunities and exposure to international regulatory markets. Swiss Parenteral Limited Hiring for Regulatory Affairs Job
Benefits of Working with Swiss Parenteral Limited
Swiss Parenteral Limited offers a work culture built on trust, innovation, and global excellence. By joining the Regulatory Affairs team, you’ll benefit from:
1. Global Exposure
Work on regulatory submissions across Africa, LATAM, MENA, and APAC regions, gaining hands-on experience with multiple international authorities.
2. Career Development
Structured career growth opportunities with performance-based promotions and training programs designed to enhance regulatory knowledge.
3. Learning Opportunities
Access to industry-leading tools, regulatory training, and documentation systems to improve technical proficiency.
4. Work Environment
Collaborative and supportive workplace with a focus on professional integrity, innovation, and compliance.
5. Recognition and Rewards
Competitive salary packages, recognition programs, and a merit-based reward system for outstanding performance.
About the Work Location – Sindhu Bhavan, Ahmedabad
The Swiss Parenteral corporate office is located in the upscale Sindhu Bhavan area of Ahmedabad, Gujarat, offering a modern and professional work environment.
Ahmedabad is a major pharmaceutical hub of India, providing excellent connectivity, infrastructure, and growth opportunities for pharmaceutical professionals. Swiss Parenteral Limited Hiring for Regulatory Affairs Job
Employees at Swiss Parenteral enjoy a balanced work-life environment, modern facilities, and the chance to work alongside a team of dedicated experts in global regulatory affairs.
How to Apply
Interested candidates who meet the eligibility criteria can apply by following the steps below: Swiss Parenteral Limited Hiring for Regulatory Affairs Job
Application Process
- Email your CV to: hroffice1@swiss.in
- Subject Line: “Application for Regulatory Affairs – Executive/Assistant Manager (Ahmedabad)”
Important Instructions
- Ensure your resume highlights your expertise in CTD, ACTD, eCTD, and dossier preparation.
- Mention your experience in parenteral products and international regulatory submissions.
- Include your current CTC, expected CTC, and notice period in your email.
- Applications from freshers will not be considered.
- Application Deadline: November 04, 2025
Shortlisted candidates will be contacted by the HR department for the next stages of the selection process. Swiss Parenteral Limited Hiring for Regulatory Affairs Job
FAQs – Swiss Parenteral Regulatory Affairs Job
Q1. What is the job role for Regulatory Affairs at Swiss Parenteral Limited?
The role involves preparing, reviewing, and submitting regulatory dossiers (CTD, ACTD, eCTD) for international markets including Africa, LATAM, MENA, and APAC.
Q2. What experience is required for this position?
Candidates should have 3–8 years of experience in core regulatory affairs, particularly with parenteral or injectable products.
Q3. What qualifications are needed to apply?
Applicants must hold a B.Pharm or M.Pharm degree from a recognized institution.
Q4. Is this job open to freshers?
No, freshers are not eligible. This role requires prior experience in regulatory documentation and submissions.
Q5. What is the salary offered for this position?
The salary ranges between ₹5,00,000 – ₹10,00,000 per annum, depending on experience and position level.
Q6. What markets will I be working with?
You’ll focus on ROW markets—specifically Africa, LATAM, MENA, and APAC regions.
Q7. Where is the job located?
The position is based at the Swiss Parenteral corporate office in Sindhu Bhavan, Ahmedabad, Gujarat.
Conclusion
The Regulatory Affairs role at Swiss Parenteral Limited is a remarkable opportunity for experienced pharmaceutical professionals looking to build a global career in compliance and documentation. With a reputation for manufacturing excellence, a wide product portfolio, and exposure to diverse markets, Swiss Parenteral offers an enriching platform to advance your expertise in regulatory affairs. Swiss Parenteral Limited Hiring for Regulatory Affairs Job
If you are a detail-oriented professional with a strong understanding of international dossier formats and compliance standards, this position is an excellent fit to elevate your pharmaceutical career.
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