The pharmaceutical regulatory landscape is evolving rapidly, and skilled professionals who can navigate global compliance standards are in high demand. Lyrus Life Sciences — a research-driven global specialty pharma CDMO — is now hiring experienced Regulatory Affairs professionals to join its expanding RA division.
If you excel in dossier preparation, regulatory compliance, and global submissions, this is a high-impact opportunity to work with a company backed by world-class R&D, cGMP manufacturing, and a leadership team with over 300+ years of combined expertise.
About Lyrus Life Sciences
Lyrus is a global specialty pharma CDMO known for its innovative and differentiated drug delivery platforms. With advanced formulation capabilities and strong global regulatory expertise, the company supports partners across the entire product lifecycle — from development to commercialization.
Role Overview — Senior Officer / Executive (Regulatory Affairs)
This role is ideal for candidates who are passionate about regulatory strategy, documentation excellence, and international market submissions.
Mandatory Technical Skills & Experience
- Minimum 4 years of hands-on experience in Regulatory Affairs
- Strong expertise in dossier preparation and lifecycle management (Modules 1–5)
- Hands-on regulatory submissions in Europe and Australia for Oral Solid Dosage (OSD) forms
- Experience in dossier preparation for US, South Africa, GCC, and ROW markets (added advantage)
- Proficiency in e-CTD software (publishing, compiling, and validation)
- Solid understanding of global regulatory guidelines (ICH/EMA/TGA/other regional)
Other Required Skills
- Strong verbal and written communication skills
- Ability to collaborate effectively with cross-functional teams
- Positive attitude with strong deadline management
- Good organizational and documentation skills
- Ability to work in a fast-paced, compliance-driven environment
Key Responsibilities
- Coordinate with cross-functional teams (R&D, QA, QC, ADL, Packaging) for timely document collection
- Review technical documents such as:
- Specifications
- Analytical Method Validation (AMV) reports
- Comparative Dissolution Profile (CDP)
- Stability reports
- Prepare and review product labels for Europe and other regulatory markets
- Prepare, compile, and submit IND dossiers for EU, TGA, and semi-regulated markets
- Prepare and submit variation sequences and handle lifecycle maintenance
- Prepare responses to regulatory queries within assigned timelines
- Maintain and update regulatory documentation & databases
- Develop and manage regulatory tracking systems for monitoring submission timelines and approvals
- Ensure compliance with global regulatory guidelines and regional filing requirements
- Support audits and provide regulatory documentation as required
Qualifications
- B.Pharm / M.Pharm (mandatory)
- 3–4+ years of experience in Regulatory Affairs
- Hands-on expertise in dossier preparation for oral or liquid dosage forms
- Experience with submissions in Europe / GCC / South Africa / ROW markets preferred
- Strong understanding of ICH, EMA, GCC, SAHPRA, and WHO guidelines
- Excellent attention to detail, documentation discipline, and cross-functional communication
Why Join Lyrus?
- Work with a fast-growing global specialty pharma CDMO
- Exposure to diverse international regulatory markets
- Opportunity to contribute to differentiated drug delivery innovations
- Collaborative and research-driven work culture
- Competitive compensation aligned with experience
How to Apply
