Swiss Parenteral Ltd., a flagship company of TM Swiss, is a leading pharmaceutical manufacturer specializing in parenteral formulations such as small volume parenterals, dry powder injections, and pre-filled syringes.
With a USFDA-approved facility and exports to over 60 countries, we are committed to delivering high-quality medicines globally. We are hosting a Walk-In Interview for Regulatory Affairs Jobs (Formulation) at our Ahmedabad office on 4 May 2025.
If you have expertise in dossier preparation and regulatory compliance, join us to advance your career in the pharmaceutical industry.
Job Opening Overview for Regulatory Affairs Roles
We are hiring for the following positions in our Regulatory Affairs (Formulation) department:
- Designation: Executive to Assistant General Manager
- Qualification: B.Pharm, B.Sc, M.Pharm, M.Sc
- Experience: 5–12 years
- Location: Ahmedabad, Gujarat
- Interview Date: Sunday, 4 May 2025
- Interview Time: 10:00 AM to 4:00 PM
- Venue: ERIS (Shilp Accord), Opp. Times Square-2, Nr. Gwalia Bloom, Ramdas Road, B/s. Ice-cream Library, Sindhu Bhavan, Bodakdev, Ahmedabad-380054, Gujarat, India
Job Description for Regulatory Affairs Jobs
Qualifications
- B.Pharm, B.Sc, M.Pharm, or M.Sc in Chemistry, Pharmaceutical Sciences, or related fields from a recognized institution.
- Strong academic background with a focus on pharmaceutical regulatory affairs.
Experience
- 5–12 years of experience in Regulatory Affairs within the pharmaceutical industry, preferably in formulation (parenterals or OSD).
- Proven expertise in dossier preparation and handling Ministry of Health (MoH) deficiency responses.
Skills
- Proficiency in dossier preparation and review in ACTD (ASEAN Common Technical Document) and CTD (Common Technical Document) formats.
- In-depth knowledge of ICH guidelines and country-specific regulatory requirements for pharmaceutical formulations.
- Ability to address MoH deficiency responses and ensure compliance with global regulatory standards.
- Strong coordination skills to work with Quality Control, Quality Assurance, and Production teams for regulatory documentation.
- Expertise in reviewing technical documents, including:
- Batch Manufacturing Records (BMR)
- Stability protocols and reports
- Specifications and methods of analysis
- Process validation protocols and reports
- Familiarity with license renewals, updates, and re-registrations for pharmaceutical products.
- Excellent communication and organizational skills for timely document compilation.
- Knowledge of GMP and GLP standards in a regulatory context.
Responsibilities
- Prepare and review dossiers in ACTD and CTD formats for regulatory submissions to global health authorities.
- Address MoH deficiency responses and ensure compliance with ICH and country-specific guidelines.
- Coordinate with Quality Control, Quality Assurance, and Production departments to compile regulatory documents.
- Review technical documents such as BMR, stability protocols, specifications, method of analysis, and process validation reports for dossier submission.
- Manage timely submission of documents for license renewals, updates, and re-registrations.
- Ensure data integrity and regulatory compliance in all documentation processes.
- Support regulatory audits and provide technical expertise during inspections.
- Stay updated on evolving global regulatory guidelines to ensure submission readiness.
Walk-In Interview Details for Pharmaceutical Jobs
Join us to explore these pharmaceutical career opportunities and meet our recruitment team:
- Date: Sunday, 4 May 2025
- Time: 10:00 AM to 4:00 PM
- Venue: ERIS (Shilp Accord), Opp. Times Square-2, Nr. Gwalia Bloom, Ramdas Road, B/s. Ice-cream Library, Sindhu Bhavan, Bodakdev, Ahmedabad-380054, Gujarat, India
Documents to Bring:
- Latest resume
- Current CTC breakup
- One recent passport-size photograph
- Educational certificates (B.Pharm, B.Sc, M.Pharm, M.Sc)
- Experience certificates
- Aadhar and PAN card copies
- Contact:
- Phone: Riddhi Chauhan (63544 17493)
- Email: hroffice1@swiss.in
Note: Swiss Parenteral Ltd. does not charge any fees for recruitment. Beware of fraudulent offers requesting payments and report suspicious activities to hroffice1@swiss.in.
How to Apply for Regulatory Affairs Jobs
Candidates can attend the walk-in interview with the required documents or apply online:
- Email: Send your CV to hroffice1@swiss.in with the subject line “Application for Regulatory Affairs – Ahmedabad Walk-In.”
- Website: Visit www.swissparenteral.com for more details about Swiss Parenteral Ltd. and career opportunities.
- Online Application: Scan the QR code (if provided in the official job posting) to apply directly.
Why Join Swiss Parenteral Ltd. for Your Pharmaceutical Career
Swiss Parenteral Ltd., part of TM Swiss, is a USFDA-approved manufacturer with a robust portfolio of parenteral formulations, including small volume parenterals, dry powder injections, prefilled syringes, and lyophilized injections. With a state-of-the-art facility in Padra, Vadodara, and exports to over 60 countries, we are a trusted name in global healthcare. By joining our Ahmedabad team, you will:
- Work in a USFDA-approved environment with exposure to global regulatory standards.
- Contribute to a company rated 3.8/5 for work culture and 4.0/5 for career growth (based on employee reviews).
- Gain expertise in dossier preparation and regulatory compliance for international markets.
- Benefit from a collaborative culture that values innovation and precision in pharmaceutical manufacturing.
Don’t miss this opportunity to advance your career in regulatory affairs jobs with Swiss Parenteral Ltd. We look forward to meeting you at the walk-in interview on 4 May 2025 in Ahmedabad!