Regulatory Affairs Jobs at Swiss Parenterals

Swiss, a third-generation family-owned business, leverages over 25 years of expertise in generic and specialty pharmaceuticals. Our proficiency extends to the development and manufacturing of a diverse range of sterile dosage forms. Operating globally, we export our products under our brand name, reaching over 80 countries.

Hiring Regulatory Affairs

IRA Head
Roles and Responsibilities :
• Lead and manage global regulatory strategy for injectable products across ROW and European markets.
• Plan, prepare, review, and submit CTD/eCTD dossiers for sterile injectables (EU, UK, ROW agencies)
• Act as the primary regulatory interface with EMA, MHRA, and ROW health authorities.
• Manage lifecycle activities including variations, renewals, PSURs, and post-approval changes.
• Co-ordinate with CMC, formulation, analytical, QA, QC, and manufacturing teams to ensure compliance.
• Address regulatory deficiencies, queries, and commitments related to injectables.
• Support regulatory inspections, audits, and facility approvals for sterile manufacturing sites.
• Monitor regulatory intelligence and ensure compliance with evolving guidelines.

Injectable Lead
Roles and Responsibilities :
• Handle regulatory submissions for sterile injectable products across global markets.
• Prepare, review, and manage CTD/eCTD modules related to injectables.
• Coordinate with formulation, analytical, QA, and manufacturing teams for dossier readiness.
• Manage post-approval changes, variations, and supplements.
• Address agency queries related to sterility, aseptic processing, and stability.
• Support regulatory inspections and compliance for injectable facilities.

Oral Solid Dosage Lead
Roles and Responsibilities :
• Lead global regulatory strategy for oral solid dosage products targeting European and ROW markets.
• Manage preparation and submission of CTD/eCTD dossiers for tablets, capsules, and modified-release products.
• Oversee post-approval submissions including variations, renewals, and line extensions.
• Ensure regulatory compliance of CMC documentation in alignment with EU and ROW guidelines.
• Coordinate cross-functionally with R&D, QA, QC, and manufacturing teams.
• Handle agency communications and deficiency responses.
• Support regulatory audits, inspections, and compliance initiatives.

Biotech Lead
Roles and Responsibilities :
• Lead and manage global regulatory strategy for biologies, biosimilars, and biotech products across Europe and ROW markets.
• Plan and execute regulatory submissions for clinical and commercial biotech dossiers.
• Ensure compliance with EMA, WHO, and ROW regulatory frameworks for biologies.
• Coordinate with clinical, non-clinical, CMC, quality, and manufacturing teams.
• Manage interactions with health authorities and responses to regulatory queries.
• Support regulatory pathways for clinical trials, approvals, and lifecycle management.
• Track regulator)' intelligence and evolving global biotech regulations.

Additional Information
Experience : 15 to 20 years relevant experience
Qualification : B.Pharm / M.Pharm / Ph.D
Functional Area : Regulatory Affairs
End Date : 10th February 2026