Lykalabs Hiring Executive – Regulatory Affairs
- Executive Regulatory Affairs (B.Pharm/M.Pharm) – Mumbai
- Company Overview
- Job Role & Responsibilities
- Core Responsibilities
- Success Metrics
- Eligibility / Qualifications
- Preferred Education
- Experience
- Technical & Professional Skills
- Relevant courses (comma-separated)
- Location & Salary
- Application Process
- FAQs
- What is the required experience for this role?
- Which educational background is preferred?
- Is this an on-site role?
- What are the main responsibilities?
- How should I apply?
Executive Regulatory Affairs (B.Pharm/M.Pharm) – Mumbai
Lykalabs hiring Executive – Regulatory Affairs. 4–6 years’ experience required. Full-time role at Grant Road, Mumbai. Apply by email.
Lykalabs is seeking an experienced Regulatory Affairs Executive to join its Grant Road, Mumbai team. This full-time, five-day role suits hands-on RA professionals who can manage regulatory submissions, maintain compliance, and support product lifecycle activities for pharmaceutical products. If you have 4–6 years of practical RA experience and want a focused role with clear ownership, this opening is for you.
Company Overview
Lykalabs operates in the pharmaceutical manufacturing and regulatory services space, supplying quality products and regulatory expertise across domestic and international markets. The company emphasizes compliance, timely submissions, and robust documentation practices. Joining Lykalabs means working within a compact, process-driven team that values regulatory excellence and operational clarity.
Job Role & Responsibilities
The Executive – Regulatory Affairs will support end-to-end regulatory processes for marketed products and new filings. Expect a mix of dossier preparation, regulatory strategy execution, and cross-functional coordination.
Core Responsibilities
- Prepare, compile, and submit regulatory dossiers and product filings in line with national regulations.
- Coordinate labeling updates, packaging inserts, and regulatory text amendments.
- Manage timelines for periodic submissions, renewals, and variations.
- Respond to queries from regulatory authorities and prepare complete responses to information requests.
- Support new product registration and launch activities, including document collation and cross-functional sign-offs.
- Maintain regulatory trackers, submission logs, and filing records to ensure audit readiness.
- Liaise with manufacturing, QC/QA, regulatory consultants, and external agencies for timely dossier completion.
- Ensure compliance with current regulatory guidelines and recommend process improvements where needed.
Success Metrics
- On-time submission of dossiers and responses.
- Reduction in queries and rework through improved dossier quality.
- Accurate and audit-ready regulatory documentation.
Eligibility / Qualifications
Preferred Education
- B.Pharm, M.Pharm, M.Sc in Pharmaceutical Sciences, Pharmacy, Life Sciences, or a closely related field (preferred).
- Formal training or certification in Regulatory Affairs is an advantage.
Experience
- 4–6 years of relevant experience in Regulatory Affairs within the pharmaceutical industry.
- Hands-on experience in dossier compilation, label management, and authority interactions is essential.
Technical & Professional Skills
- Strong understanding of drug regulatory submissions and compliance requirements.
- Proven ability to prepare CTD/eCTD modules and manage lifecycle submissions.
- Good written communication and scientific documentation skills.
- Proficiency with MS Office and regulatory tracking systems.
- Collaborative working style and stakeholder management.
Relevant courses (comma-separated)
B.Pharm, M.Pharm, M.Sc Pharmaceutical Sciences, Postgraduate Diploma in Regulatory Affairs, Certificate in Drug Regulatory Affairs, Clinical Research Certification.
Location & Salary
- Location: Grant Road, Mumbai, Maharashtra.
- Work Mode: On-site, full-time (5 days week).
- Compensation: Competitive and commensurate with experience and skills. Exact salary will be discussed during the interview process.
Application Process
Interested candidates should email their CV and a brief cover note to both:
manasi.gaidhani@lykalabs.com and ashish.sawant@lykalabs.com.
Use the subject line: “Application – Executive Regulatory Affairs | Your Name | 4–6 yrs”
Include in your email: current CTC, expected CTC, and notice period. Shortlisted candidates will be contacted for a technical interview followed by HR discussion.
FAQs
What is the required experience for this role?
4–6 years in regulatory affairs within the pharmaceutical industry.
Which educational background is preferred?
Degrees in Pharmacy or Pharmaceutical Sciences (B.Pharm/M.Pharm) are preferred; related life-science degrees may be considered.
Is this an on-site role?
Yes. The role is based at Grant Road, Mumbai and follows a five-day working week.
What are the main responsibilities?
Dossier compilation, regulatory submissions, labeling updates, responses to regulatory queries, and maintaining submission trackers.
How should I apply?
Email your CV and cover note to manasi.gaidhani@lykalabs.com and ashish.sawant@lykalabs.com with the specified subject line.
| Category | Details |
|---|---|
| Company | Lykalabs, Grant Road, Mumbai |
| Vacancies | Executive – Regulatory Affairs |
| Required Education | B.Pharm, M.Pharm, M.Sc Pharmaceutical Sciences (preferred) |
| Experience | 4–6 years in Regulatory Affairs |
To apply for this job email your details to manasi.gaidhani@lykalabs.com
