Are you a Regulatory Affairs Specialist with experience in dossier preparation, ICH guidelines, and LATAM regulations? Swiss Parenterals Ltd, a leading pharmaceutical company, is looking for a skilled Regulatory Affairs Specialist to join their team in Ahmedabad, Gujarat.
This is a full-time, on-site opportunity for professionals with 3 to 15 years of experience in regulatory affairs. If you have expertise in dossier compilation, deficiency response, and regulatory compliance, this could be the perfect role for you!
Job Details
- Position: Regulatory Affairs Specialist
- Company: Swiss Parenterals Ltd
- Location: Ahmedabad, Gujarat (On-site)
- Experience: 3 to 15 years
- Job Type: Full-time
Key Responsibilities
As a Regulatory Affairs Specialist, your role will include:
- Dossier Review & Compilation: Preparing and reviewing dossiers in ACTD, CTD, and country-specific formats as per regulatory guidelines.
- Deficiency Response: Addressing MoH deficiencies, queries, and Notices of Deficiency (NoD) from regulatory authorities.
- Regulatory Compliance: Ensuring adherence to ICH and LATAM country-specific guidelines.
- Document Coordination: Working with QC, QA, and Production teams to gather necessary regulatory documents.
- License Management: Handling license renewals, updates, and re-registrations.
- Artwork Review: Checking Package Inserts, SmPCs, labels, and cartons for regulatory compliance.
- Tender Documentation: Compiling technical dossiers for tender submissions.
- Change Control: Reviewing changes in SOPs, BMRs, stability protocols, and validation reports for regulatory impact.
Required Skills & Qualifications
- Experience: 3+ years in pharmaceutical regulatory affairs.
- Dossier Expertise: Strong knowledge of ACTD, CTD, and country-specific dossier formats.
- Regulatory Guidelines: Familiarity with ICH, LATAM, and other international regulations.
- Deficiency Handling: Ability to respond to MoH queries and deficiencies effectively.
- Cross-functional Coordination: Collaboration with QC, QA, and Production teams.
- Attention to Detail: Ensuring accuracy in documentation and compliance.
Why Join Swiss Parenterals Ltd?
- Industry Leader: Work with a reputed pharmaceutical company.
- Growth Opportunities: Enhance your career in global regulatory affairs.
- Dynamic Work Environment: Engage in challenging and rewarding projects.
How to Apply?
If you meet the eligibility criteria, send your updated resume to hroffice1@swiss.in.
