Job Title Options: Regulatory Affairs & Compliance

Department: Regulatory Affairs / Legal & Quality

Reports To: Accounts & Finance Head & MD

Role Overview

We are seeking a detail-oriented Regulatory Affairs & Compliance Specialist to oversee end-to-end FDA licensing, CDSCO approvals, import clearances, and corporate legal documentation. The ideal candidate will act as the crucial link between internal teams (QA, Sales, Operations) and external regulatory bodies to ensure seamless product applications, certifications, and operational compliance.

Key Responsibilities

1. Regulatory Affairs & FDA Licensing

· Prepare, submit, and track FDA product applications and schedules for all new and existing products.

· Manage end-to-end certification lifecycle, including timely renewals for ISO, CE, and FDA certifications.

· Maintain complete regulatory audit readiness and update progress trackers for senior management.

2. Import & CDSCO Clearance

· File and acquire CDSCO NOCs (Central Drugs Standard Control Organisation) and PIMS (Paper Import Monitoring System) certificates to facilitate smooth import customs clearance.

· Ensure all import documentation aligns with national regulatory guidelines to prevent transit delays.

3. Cross-Functional Coordination

· With Quality Assurance (QA): Gather and verify technical files, including Ingredient Sheets, Certificates of Analysis (COA), and Methods of Analysis (MOA).

· With Sales & Marketing: Review and approve product artwork, labeling, and provide required FDA letters/certificates to support commercial operations.

4. Corporate Statutory & Legal Documentation

· Draft, execute, and renew office/warehouse rent agreements and lease deeds.





· Maintain up-to-date physical and digital archives of company statutory documents, trade licenses, and legal filings.

· Assist in general legal compliance, corporate filings, and operational regulatory matters as required.

Candidate Profile & Qualifications

· Education: Bachelor’s degree in Pharmacy (B.Pharm / M.Pharm), Life Sciences, Chemistry, or Law (LLB) preferred.

· Experience: 2–5 years of hands-on experience in Regulatory Affairs, CDSCO filing, and FDA documentation (Pharma, Medical Devices, Cosmetics, or Nutraceuticals).

· Technical Skills:

o In-depth knowledge of CDSCO online portals (SUGAM / National Single Window System), PIMS portal, and local FDA licensing norms.

o Practical understanding of ISO, CE marking guidelines, and QA document formats (COA, MOA, MSDS).

o Familiarity with basic legal agreement drafting and statutory documentation management.

· Soft Skills: Strong cross-functional coordination, assertive follow-up capabilities, keen attention to detail, and excellent written/verbal communication.

Pay: ₹20,000.00 - ₹30,000.00 per month

Advantages:

- Paid sick time
- Provident Fund

Application Question(s):

- Do you have degree in Bachelor’s degree in Pharmacy (B.Pharm / M.Pharm), Life Sciences, Chemistry, or Law (LLB) ?
- Do you have experience into Regulatory Affairs & FDA Licensing, Import & CDSCO Clearance, Cross-Functional Coordination, ?
- Do you have experience into Corporate Statutory & Legal Documentation ?
- i have read the JD carefully and i do qualify for this role ?
- Do you stay between bhayandar-virar and ready to travel between vasai-bhiwandi road with 06 working days ?

Work Location: In person

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