Senior Regulatory Affairs Leadership Jobs at Swiss Parenterals
Swiss Parenterals Ltd. is strengthening its global Regulatory Affairs leadership team and invites highly experienced professionals to apply for senior-level regulatory positions at its corporate office in Ahmedabad, Gujarat. These leadership roles are intended for seasoned regulatory experts who can design, execute, and govern regulatory strategies across injectables, oral solid dosage forms, and biotechnology portfolios in regulated and semi-regulated markets.
This is a high-impact opportunity for regulatory leaders who want to influence global product approvals, compliance frameworks, and long-term regulatory sustainability within a rapidly expanding pharmaceutical organization. Senior Regulatory Affairs Leadership Jobs
Company Overview
Swiss Parenterals Ltd. is a globally respected pharmaceutical organization with deep expertise in sterile injectables, complex dosage forms, and regulated-market manufacturing. The company has established a strong presence across Europe, the United Kingdom, and multiple Rest of World (ROW) regions through consistent regulatory performance and quality-driven operations.
Swiss Parenterals operates with a strong focus on compliance excellence, regulatory foresight, and patient safety. Its regulatory framework is aligned with international health authorities such as EMA, MHRA, WHO, and other global agencies, enabling successful approvals and lifecycle management of complex pharmaceutical products. Senior Regulatory Affairs Leadership Jobs
Job Location & Employment Type
- Corporate Location: Bodakdev, Ahmedabad, Gujarat
- Employment Type: Full-Time
- Functional Area: Global Regulatory Affairs
- Level: Senior Leadership / Head / Lead Roles
Open Positions / Department Details
Swiss Parenterals is hiring for the following senior regulatory leadership positions:
- IRA Head – Regulatory Affairs (Injectables)
- Regulatory Affairs Lead – Injectables
- Regulatory Affairs Lead – Oral Solid Dosage (OSD)
- Regulatory Affairs Lead – Biotechnology
These positions are part of the central Regulatory Affairs leadership team and involve cross-functional and global regulatory responsibilities.
Key Roles & Responsibilities
IRA Head – Regulatory Affairs (Injectables)
The IRA Head will be responsible for defining and leading the global regulatory strategy for sterile injectable products across EU, UK, and ROW markets. Senior Regulatory Affairs Leadership Jobs
Key responsibilities include:
- Developing long-term regulatory strategies for injectable product portfolios
- Leading preparation, review, and submission of CTD and eCTD dossiers
- Acting as the primary regulatory representative with global health authorities
- Managing lifecycle regulatory activities including variations, renewals, and post-approval changes
- Overseeing regulatory responses to agency queries, commitments, and deficiencies
- Collaborating with CMC, formulation, analytical, QA, QC, and manufacturing teams
- Supporting regulatory inspections, audits, and sterile facility approvals
- Monitoring regulatory intelligence and implementing evolving global guidelines
- Mentoring and guiding regulatory teams across markets
Regulatory Affairs Lead – Injectables
This role focuses on hands-on regulatory leadership for sterile injectable submissions and compliance activities. Senior Regulatory Affairs Leadership Jobs
Key responsibilities include:
- Managing CTD/eCTD dossier compilation and submission for injectables
- Coordinating with internal technical and quality teams for dossier readiness
- Handling post-approval changes, supplements, and variations
- Responding to regulatory queries related to sterility, aseptic processing, and stability
- Supporting inspections and regulatory audits for injectable facilities
- Ensuring ongoing compliance with EU and ROW regulatory requirements
Senior Regulatory Affairs Leadership Jobs
Regulatory Affairs Lead – Oral Solid Dosage (OSD)
The OSD Regulatory Lead will oversee regulatory activities for tablets, capsules, and modified-release products. Senior Regulatory Affairs Leadership Jobs
Key responsibilities include:
- Driving regulatory strategy for oral solid dosage portfolios
- Managing submissions for EU and ROW markets
- Overseeing lifecycle management activities for approved products
- Ensuring CMC documentation compliance with global regulatory guidelines
- Coordinating with R&D, QA, QC, and manufacturing teams
- Preparing and managing responses to regulatory authority queries
- Supporting regulatory intelligence and change management initiatives
Regulatory Affairs Lead – Biotechnology
The Biotech Lead will manage regulatory strategies for biologics, biosimilars, and advanced biotech products. Senior Regulatory Affairs Leadership Jobs
Key responsibilities include:
- Developing regulatory pathways for biologics and biosimilar products
- Managing clinical and commercial biotech submissions
- Ensuring compliance with EMA, WHO, and global biotech frameworks
- Coordinating with clinical, non-clinical, CMC, and quality teams
- Handling health authority interactions and regulatory correspondence
- Supporting clinical trial approvals, marketing authorizations, and lifecycle activities
- Tracking global regulatory trends impacting biotechnology products
Eligibility Criteria
Educational Qualifications
Candidates must possess one of the following qualifications:
- B.Pharm
- M.Pharm
- Ph.D in Pharmaceutical Sciences or related disciplines
Relevant academic backgrounds may include Regulatory Affairs, Pharmaceutics, Pharmaceutical Technology, Quality Assurance, Biotechnology, or Clinical Regulatory Sciences.
Experience Requirements
- 15 to 20 years of progressive Regulatory Affairs experience
- Demonstrated leadership exposure in regulated markets
- Mandatory portfolio-specific expertise depending on the applied role:
- Injectables for IRA Head and Injectable Lead
- Oral Solid Dosage for OSD Lead
- Biologics / Biosimilars for Biotech Lead
- Proven experience with EU, UK, and ROW regulatory submissions
Senior Regulatory Affairs Leadership Jobs
Salary & Benefits
- Compensation: As per company norms (senior leadership level)
- Salary will be commensurate with experience, portfolio responsibility, and regulatory expertise
- Competitive package aligned with industry benchmarks for global regulatory leadership roles
Selection Process
The selection process may include:
- Profile screening based on regulatory expertise and leadership exposure
- Technical and strategic discussions with senior management
- Final HR and leadership interaction
Shortlisted candidates will be contacted directly by the Swiss Parenterals HR team. Senior Regulatory Affairs Leadership Jobs
How to Apply
Interested senior professionals can apply by emailing their updated resume to:
📌 Important: Clearly mention the applied position (e.g., IRA Head – Regulatory Affairs or Regulatory Affairs Lead – Injectables) in the email subject line.
Important Dates
- Job Posted: Recently
- Last Date to Apply: Not specified
Candidates are encouraged to apply at the earliest due to leadership-level shortlisting.
Why Apply for This Pharma Job?
Leadership roles at Swiss Parenterals offer unmatched professional influence and global exposure: Senior Regulatory Affairs Leadership Jobs
- Opportunity to lead regulatory strategy for complex and high-value portfolios
- Direct involvement in EU, UK, and ROW regulatory approvals
- High-impact decision-making role within a global pharmaceutical organization
- Exposure to injectables, OSD, and biotechnology regulatory frameworks
- Platform to mentor teams and shape long-term regulatory direction
- Contribution to global patient access through compliant and timely approvals
This is an ideal opportunity for regulatory leaders seeking strategic responsibility and global visibility. Senior Regulatory Affairs Leadership Jobs
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent pharmaceutical job information platform and is not affiliated with Swiss Parenterals Ltd. or its recruitment process. All job details are shared for informational purposes only. Candidates should independently verify role requirements and company details before applying. IndiaPharmaJobs.in does not charge any fee for job listings or applications. Senior Regulatory Affairs Leadership Jobs
Final Call-to-Action
If you are a senior Regulatory Affairs professional with extensive experience in injectables, oral solid dosage, or biotechnology portfolios and are ready to take on a leadership role influencing global regulatory outcomes, apply now to Swiss Parenterals. This is your opportunity to lead regulatory excellence at an international level. Senior Regulatory Affairs Leadership Jobs
