Swiss Hiring IRA Head & Regulatory Leads

B.Pharm M.Pharm PhD Regulatory Jobs | Swiss Ahmedabad

Swiss Parenterals hiring IRA Head & Regulatory Leads in Ahmedabad. B.Pharm, M.Pharm, PhD eligible. Senior leadership roles.

Swiss Parenterals Ltd. is hiring senior regulatory leadership professionals to strengthen its global Regulatory Affairs function at its corporate location in Ahmedabad, Gujarat. These openings are designed for highly experienced professionals who can lead complex regulatory strategies across injectable, oral solid dosage, and biotechnology portfolios for European and ROW markets.

This hiring initiative reflects Swiss Parenterals’ continued expansion in regulated markets, where robust regulatory leadership plays a critical role in ensuring timely approvals, compliance excellence, and global access to life-saving pharmaceutical products.

Company Overview

Swiss Parenterals Ltd. is a globally respected pharmaceutical company specializing in sterile injectables, complex formulations, and regulated-market pharmaceutical manufacturing. With a strong footprint across Europe, the UK, and ROW markets, the company operates with a sharp focus on regulatory compliance, quality systems, and patient safety.

Driven by the philosophy of “Empowering Growth through Collective Strengths,” Swiss Parenterals has built regulatory and manufacturing capabilities aligned with EMA, MHRA, WHO, and other global health authority requirements. Its leadership-driven regulatory structure ensures sustainable growth across multiple therapeutic and dosage platforms.

Job Role & Responsibilities

IRA Head – Regulatory Affairs (Injectables)

The IRA Head will lead and manage the global regulatory strategy for sterile injectable products across European and ROW markets.

Key responsibilities include:

• Defining and executing global regulatory strategies for injectable portfolios
• Planning, preparing, reviewing, and submitting CTD and eCTD dossiers for EU, UK, and ROW agencies
• Acting as the primary regulatory interface with EMA, MHRA, and other health authorities
• Managing lifecycle activities including variations, renewals, PSURs, and post-approval changes
• Coordinating with CMC, formulation, analytical, QA, QC, and manufacturing teams to ensure dossier readiness
• Addressing regulatory deficiencies, commitments, and agency queries related to injectables
• Supporting regulatory inspections, audits, and sterile facility approvals
• Monitoring regulatory intelligence and ensuring compliance with evolving global guidelines

Regulatory Affairs – Injectable Lead

The Injectable Lead will handle regulatory submissions and compliance activities for sterile injectable products.

Key responsibilities include:

• Managing CTD/eCTD dossier preparation for injectable products across global markets
• Coordinating with formulation, analytical, QA, and manufacturing teams
• Handling post-approval changes, variations, and supplements
• Responding to agency queries related to sterility assurance, aseptic processing, and stability
• Supporting regulatory inspections and audits for injectable manufacturing sites

Regulatory Affairs – Oral Solid Dosage (OSD) Lead

The OSD Lead will oversee regulatory strategies and submissions for tablets, capsules, and modified-release formulations.

Key responsibilities include:

• Leading regulatory strategy for oral solid dosage products for EU and ROW markets
• Managing CTD/eCTD submissions for tablets, capsules, and MR products
• Overseeing post-approval lifecycle management activities
• Ensuring CMC documentation compliance with EU and ROW guidelines
• Coordinating with R&D, QA, QC, and manufacturing teams
• Managing deficiency responses and agency communications

Regulatory Affairs – Biotech Lead

The Biotech Lead will manage global regulatory activities for biologics, biosimilars, and biotechnology products.

Key responsibilities include:

• Developing and executing regulatory strategies for biologics and biosimilars
• Managing clinical and commercial biotech dossier submissions
• Ensuring compliance with EMA, WHO, and global biotech regulatory frameworks
• Coordinating with clinical, non-clinical, CMC, quality, and manufacturing teams
• Managing health authority interactions and regulatory query responses
• Supporting regulatory pathways for clinical trials, approvals, and lifecycle management
• Tracking global regulatory intelligence related to biotech products

Eligibility / Qualifications

Educational Requirements

• B.Pharm
• M.Pharm
• Ph.D (Pharmaceutical Sciences or related disciplines)

Relevant courses include: Regulatory Affairs, Pharmaceutics, Pharmaceutical Technology, Quality Assurance, Biotechnology, Clinical Regulatory Sciences

Experience Criteria

• 15–20 years of relevant Regulatory Affairs experience
• Proven leadership exposure in EU and ROW regulatory markets
• Mandatory experience with injectables, OSD, or biotech portfolios depending on role

Location & Salary

Work location: Bodakdev, Ahmedabad, Gujarat.

Salary will be offered at senior leadership levels and will be commensurate with experience, portfolio responsibility, and regulatory expertise. Compensation aligns with industry benchmarks for global regulatory leadership roles.

Application Process

Senior professionals interested in these leadership roles can apply by sharing their updated resume via email:

• hroffice1@swiss.in
• hroffice@swiss.in

Candidates are advised to mention the applied leadership position clearly in the email subject line.

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Why Join Swiss Parenterals in a Leadership Role

Leadership roles at Swiss Parenterals offer the opportunity to influence global regulatory outcomes for complex injectable, oral solid, and biotech products. Professionals in these positions directly contribute to faster approvals, sustained compliance, and global patient access to advanced pharmaceutical therapies across regulated markets.

FAQs

Who can apply for these leadership positions?

Candidates with B.Pharm, M.Pharm, or Ph.D qualifications and 15–20 years of regulatory affairs experience can apply.

Is injectable experience mandatory?

Yes. Strong injectable regulatory exposure is mandatory for the IRA Head and Injectable Lead roles.

Which markets are covered?

European Union, UK, and multiple ROW markets including Africa, CIS, ASEAN, LATAM, and MENA.

Can candidates from biotech backgrounds apply?

Yes. The Biotech Lead role is specifically designed for professionals with biologics and biosimilar regulatory experience.

How can I apply?

You can apply by emailing your resume to the provided Swiss Parenterals HR email IDs.

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Company	Swiss Parenterals Ltd.
Vacancies	IRA Head – Regulatory Affairs, Regulatory Affairs Injectable Lead, Regulatory Affairs OSD Lead, Regulatory Affairs Biotech Lead
Required Education	B.Pharm, M.Pharm, Ph.D
Experience	15–20 years