Lyrus Life Sciences Hiring for Senior Officer / Executive Regulatory Affairs professionals in Bangalore for global dossier preparation and international regulatory submissions.
Lyrus Life Sciences Hiring for Senior Officer / Executive – Regulatory Affairs in Bangalore | Apply Online
The pharmaceutical industry continues to witness rapid expansion in global markets, and regulatory affairs professionals play a critical role in ensuring safe, compliant, and timely product approvals. In line with this growing demand, Lyrus Life Sciences, a fast-growing global specialty pharma CDMO, has announced new hiring for the position of Senior Officer / Executive – Regulatory Affairs at its Bangalore location.
This opportunity is ideal for experienced regulatory professionals who possess strong expertise in dossier preparation, international regulatory submissions, lifecycle management, and compliance with global regulatory authorities. If you have hands-on exposure to EU, Australia, GCC, South Africa, or ROW submissions and are seeking a growth-oriented role with a research-driven organization, this opening at Lyrus could be the right step in your career.
This is a verified job opportunity, and the company is accepting applications through online application mode.
🟩 Key Highlight Box – Lyrus Life Sciences Regulatory Affairs Job 2025
- Company Name: Lyrus Life Sciences
- Job Title: Senior Officer / Executive – Regulatory Affairs
- Job Location: Bangalore
- Industry Type: Global Specialty Pharma CDMO
- Educational Qualification: B.Pharm / M.Pharm
- Experience Required: 3 to 4+ Years
- Dosage Forms: Oral Solid Dosage (OSD) and Liquid
- Regulatory Markets: Europe, Australia, US, GCC, South Africa, ROW
- Key Skill Area: Dossier Preparation, eCTD Publishing, Global Submissions
- Employment Type: Full-Time, Permanent
- Application Mode: Online Application
- Job Status: Verified Job Opening
About Lyrus Life Sciences
Lyrus Life Sciences is a research-driven global specialty pharmaceutical Contract Development and Manufacturing Organization (CDMO), well recognized for its innovative drug delivery platforms, advanced formulation expertise, and robust regulatory capabilities. The company supports pharmaceutical partners across the entire product lifecycle — from early-stage formulation development to commercial manufacturing and global product registration.
What sets Lyrus apart is its:
- Differentiated drug delivery technologies
- Strong regulatory science expertise
- End-to-end formulation and manufacturing capabilities
- Compliance with global cGMP standards
- Leadership team with 300+ years of combined pharmaceutical industry experience
With a growing international footprint, Lyrus continues to expand its regulatory affairs division to support global filings, lifecycle maintenance, and compliance strategies across regulated and semi-regulated markets.
Overview of the Role – Senior Officer / Executive (Regulatory Affairs)
The Senior Officer / Executive – Regulatory Affairs position at Lyrus Life Sciences is a high-impact role focused on global dossier preparation, regulatory submissions, and lifecycle management for multiple international markets.
This role is best suited for candidates who:
- Have hands-on experience in CTD and eCTD dossier preparation (Modules 1–5)
- Are well-versed in EU and Australia regulatory submissions for Oral Solid Dosage (OSD) products
- Possess strong understanding of ICH, EMA, TGA, GCC, SAHPRA, and WHO guidelines
- Enjoy working in a compliance-driven, documentation-intensive, and cross-functional environment
You will work closely with R&D, QA, QC, Packaging, Analytical Development (ADL), and other internal teams to ensure timely and compliant regulatory submissions.
Mandatory Technical Skills & Experience
To be considered for this role, candidates must possess the following mandatory technical expertise:
- Minimum 4 years of hands-on Regulatory Affairs experience
- Strong proficiency in dossier preparation and lifecycle management (CTD Modules 1–5)
- Practical experience in regulatory submissions to Europe and Australia for Oral Solid Dosage (OSD) products
- Experience in dossier preparation for US, South Africa, GCC, and ROW markets is considered a strong advantage
- Sound working knowledge of electronic CTD (eCTD) software including:
- Publishing
- Compiling
- Validation
- Strong understanding of global regulatory guidelines including ICH, EMA, TGA, and regional authorities
Other Important Professional Skills Required
In addition to technical RA expertise, candidates must demonstrate the following professional attributes:
- Strong verbal and written communication skills
- Ability to collaborate effectively in cross-functional team environments
- A positive, solution-oriented attitude with strong deadline management
- High level of organizational discipline and documentation accuracy
- Ability to work efficiently in a fast-paced, audit-ready, compliance-driven environment
Detailed Key Responsibilities
As a Senior Officer / Executive – Regulatory Affairs at Lyrus Life Sciences, your core responsibilities will include:
1. Cross-Functional Coordination
You will coordinate with multiple internal departments such as:
- Research & Development (R&D)
- Quality Assurance (QA)
- Quality Control (QC)
- Analytical Development Laboratory (ADL)
- Packaging and Manufacturing
Your role will be to ensure timely collection, review, and compilation of documents required for regulatory submissions.
2. Review of Technical & Scientific Documents
You will be responsible for reviewing critical regulatory documents such as:
- Finished Product Specifications
- Analytical Method Validation (AMV) Reports
- Comparative Dissolution Profiles (CDP)
- Stability Study Reports
Ensuring scientific accuracy, regulatory compliance, and proper formatting is a key responsibility.
3. Labeling and Artwork Compliance
You will:
- Prepare and review product labels for Europe and other international regulatory markets
- Ensure compliance with regional labeling requirements and pharmacovigilance expectations
- Coordinate packaging artwork approvals and revisions
4. Regulatory Submissions & Lifecycle Management
You will independently or collaboratively:
- Prepare, compile, and submit IND dossiers for:
- Europe (EMA)
- Australia (TGA)
- Semi-regulated markets
- Handle post-approval lifecycle management, including:
- Variation submissions
- Change notifications
- Renewal applications
- Track queries from regulatory authorities and coordinate timely responses
5. Regulatory Query Responses
You will:
- Prepare technically sound responses to regulatory agency questions
- Coordinate with internal scientific teams for data clarification
- Ensure all responses are submitted within assigned regulatory timelines
6. Regulatory Data Management & Tracking
You will maintain:
- Regulatory documentation databases
- Submission trackers
- Approval status records
- Market-wise regulatory progress dashboards
These tools help ensure transparency and proactive regulatory planning.
7. Compliance & Audit Support
You will:
- Ensure ongoing compliance with global regulatory guidelines
- Support internal and external audits
- Provide regulatory documentation during inspections
- Assist in CAPA implementation related to regulatory findings
Educational Qualification
Candidates applying for this role must possess:
- B.Pharm or M.Pharm (mandatory qualification)
- 3–4+ years of relevant Regulatory Affairs experience
- Hands-on experience in dossier preparation for oral and/or liquid dosage forms
Preferred Regulatory Market Exposure
Candidates with experience in the following markets will be given strong preference:
- Europe (EMA)
- Australia (TGA)
- GCC Countries
- South Africa (SAHPRA)
- Rest of World (ROW) semi-regulated markets
- United States (added advantage)
Required Regulatory Knowledge Base
Applicants must have strong working knowledge of the following guidelines:
- ICH Guidelines (Q, E, M series)
- EMA Regulatory Framework
- TGA Regulations
- GCC Regulatory Guidelines
- WHO Technical Reports
- SAHPRA Requirements
Work Location
- City: Bangalore
- State: Karnataka
- Work Environment: Compliance-focused, documentation-intensive RA operations
This role offers excellent exposure to global regulatory submissions from India’s leading pharmaceutical regulatory hub.
Why Join Lyrus Life Sciences
Joining Lyrus Life Sciences offers several long-term professional and technical advantages:
- Opportunity to work with a high-growth global specialty pharma CDMO
- Strong exposure to multiple international regulatory markets
- Opportunity to contribute to innovative and differentiated drug delivery systems
- Collaborative, research-driven, and quality-focused work culture
- Competitive salary structure aligned with market standards
- Strong visibility in global regulatory strategy programs
- Long-term career progression in regulatory leadership roles
Career Growth Opportunities
This role can lead to future advancements such as:
- Manager – Regulatory Affairs
- Global Regulatory Strategy Lead
- CMC Regulatory Specialist
- Regulatory Submission Manager
- International Regulatory Program Leader
Lyrus actively supports internal growth, learning programs, and leadership development initiatives.
Who Should Apply
You should consider applying if:
- You have 3–4+ years of hands-on Regulatory Affairs experience
- You have independently handled CTD/eCTD dossier preparation
- You have exposure to EU and Australia submissions
- You are comfortable handling cross-functional coordination and tight regulatory timelines
- You want to build a long-term career with a global specialty pharma CDMO
✅ How to Apply for Lyrus Life Sciences Regulatory Affairs Job
Interested and eligible candidates can apply through the official online application link provided by the company.
Application Guidelines:
- Prepare an updated resume highlighting:
- Regulatory markets handled
- Dossier experience (Modules 1–5)
- eCTD tools knowledge
- Products and dosage forms worked on
- Mention clearly:
- Total years of RA experience
- Markets handled (EU, TGA, GCC, SA, US, ROW)
- Current and expected CTC
- Notice period
- Submit your application through the official Lyrus Life Sciences career portal using the online application option mentioned in the job listing.
Early applicants will be preferred as shortlisting will be done on a rolling basis.
Final Conclusion
The Senior Officer / Executive – Regulatory Affairs role at Lyrus Life Sciences, Bangalore, is a highly strategic opportunity for regulatory professionals who want to work on global dossiers, international submissions, and complex regulatory programs within a fast-growing specialty pharmaceutical organization.
With strong leadership, world-class R&D support, cutting-edge formulation technologies, and expanding global presence, Lyrus offers an ideal platform to build a powerful regulatory career.
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