Executive – Regulatory Affairs Openings at Lyka Labs Mumbai
Apply for Executive – Regulatory Affairs role at Lyka Labs, Mumbai. Openings for pharma professionals with 5–7 years’ experience.
Lyka Labs, a leading pharmaceutical company, is inviting applications for the role of Executive – Regulatory Affairs at its Grant Road, Mumbai location. This full-time role is ideal for experienced regulatory professionals eager to contribute to global compliance and product registrations.
Company Overview
Lyka Labs is a trusted name in the Indian and global pharmaceutical industry, recognized for its innovative formulations, compliance-driven operations, and international market presence. With a focus on quality and patient safety, Lyka Labs has earned approvals from major regulatory bodies like USFDA, MHRA, and WHO-GMP. Joining Lyka Labs means advancing your career in a company committed to excellence and innovation in healthcare.
Job Role & Responsibilities
As an Executive – Regulatory Affairs, your responsibilities will include:
- Preparing, reviewing, and submitting regulatory dossiers for domestic and international markets.
- Ensuring compliance with global regulatory guidelines (USFDA, EMA, MHRA, WHO, CDSCO).
- Handling lifecycle management of approved products including variations and renewals.
- Collaborating with cross-functional teams (F&D, QA, QC, Manufacturing) to support regulatory submissions.
- Maintaining regulatory intelligence and monitoring updates from global agencies.
- Supporting audits and inspections by regulatory authorities.
Eligibility / Qualifications
- Education: B.Pharm, M.Pharm, or M.Sc (Pharmaceutical Sciences, Biotechnology, Chemistry).
- Experience: 5–7 years in Regulatory Affairs within the pharmaceutical industry.
- Skills Required:
- Strong knowledge of dossier preparation (CTD/eCTD formats).
- Familiarity with ANDA, DMF, and MAA submissions.
- Excellent communication and documentation skills.
Location & Salary
- Location: Grant Road, Mumbai.
- Job Type: Full-time (5 days working).
- Salary: Competitive, as per industry standards.
Application Process
Interested candidates may send their updated CVs to:
- Emails: manasi.gaidhani@lykalabs.com, ashish.sawant@lykalabs.com
(Use subject line: Executive – Regulatory Affairs)
Apply before 23rd August 2025 to secure your chance to join Lyka Labs’ Regulatory Affairs team!
FAQs
1. Who can apply for this role?
Pharma professionals with 5–7 years’ experience in Regulatory Affairs and relevant educational qualifications.
2. Is prior experience mandatory?
Yes, candidates must have hands-on experience in regulatory submissions and product lifecycle management.
3. What is the job location?
Grant Road, Mumbai.
4. What is the work schedule?
Full-time role with a 5-day work week.
5. How do I apply?
Send your CV to manasi.gaidhani@lykalabs.com and ashish.sawant@lykalabs.com.
Summary Table
Category | Details |
---|---|
Company | Lyka Labs Ltd. |
Vacancies | Executive – Regulatory Affairs |
Required Education | B.Pharm, M.Pharm, M.Sc (Pharma Sciences, Biotechnology, Chemistry) |
Experience | 5–7 Years |
To apply for this job email your details to ashish.sawant@lykalabs.com