The Regulatory & Compliance Specialist is responsible for ensuring that all products, processes, documentation, and business operations comply with USFDA, European, and other international regulatory requirements. This role supports product registrations, dossier preparation, audits, labeling compliance, and regulatory strategy for new and existing products of our Private label and Guar Gum business.
Job Highlights
- Hands-on US FDA regulatory experience with strong knowledge of CFR 21
- Manage NDC filings, FDA registrations, and compliance activities
Role & responsibilities
US FDA Submissions & Registrations
- Manage NDC filings for OTC and prescription drug products, including annual renewals
- Handle Drug Establishment Registration and facility compliance under CFR 21
- Manage GDUFA, OMUFA, and MoCRA-related filings and renewals
- Request and maintain FEI and DUNS registrations
Cosmetic & OTC Compliance
- Manage MoCRA cosmetic facility registrations and product listings
- Review and approve artworks and labels as per US FDA and US Cosmetics Act
- Handle cosmetic ingredient listings and labeler code requests
Port & Import Compliance
- Handle FDA shipment holds at US ports and coordinate resolution with customs brokers and FDA
- Respond to FDA queries including IR, DRL, ECD, and CRL
- Manage controlled correspondence and documentation with US FDA
Lifecycle & Ongoing Compliance
- Manage post-approval lifecycle activities including Annual Reports, PADER, CBE-0, CBE-30, and PAS
- Track and file OMUFA and other recurring compliance fees
- Manage WDD and 3PL registrations and renewals
- Submit one-time marketing reports and CDER Direct NextGen Portal reporting
- Handle CMC and labeling-related queries from FDA
- Support medicated animal feed facility registrations where applicable
Systems & Tools
- Work with SPL and eCTD software for regulatory submissions
- Maintain regulatory trackers, documentation, and compliance calendars
Customer & Internal Coordination
- Act as regulatory point of contact for customers and internal stakeholders
- Communicate regulatory status, timelines, and FDA feedback clearly
- Coordinate regulatory inputs during audits, inspections, or customer discussions
Cross-Functional Coordination
- Liaise with QA, Production, R&D, Packaging, & Export teams for regulatory requirements.
- Coordinate with third-party consultants, testing labs, and regulatory agencies as needed.
Compliance & Audit Management
- Ensure compliance with applicable USFDA CFR, EU Regulations, GMP, and quality systems.
- Support internal and external regulatory audits including USFDA inspections, EU audits, and cGMP audits.
- Conduct periodic compliance checks and gap assessments; recommend corrective actions.
NON-NEGOTIABLE REQUIREMENTS
- Hands-on US FDA regulatory experience (not academic-only)
- Strong working knowledge of CFR 21
- Prior exposure to NDC filings, renewals, and FDA correspondence
- Experience handling FDA import holds or live regulatory issues
- Comfort working in a fast-paced, export-driven environment
Preferred candidate profile
- 5-7 years of relevant US FDA regulatory experience
- Strong English communication skills (written and verbal)
- Detail-oriented with strong documentation discipline
- Ability to manage multiple timelines independently. Practical, compliance-first mindset
Qualifications & Skills
- Bachelor's or Master's in Pharmacy, Life Sciences, Biotechnology, Chemistry, or related field.
Experience
- 5-6 years of hands-on experience in regulatory affairs and compliance.
- Strong knowledge of USFDA regulations, EU regulatory guidelines, GMP, and global regulatory frameworks.
Technical Skills
- Understanding of USFDA CFR (21 CFR parts relevant to product category).
- Knowledge of EU directives/regulations (MDR, IVDR, REACH, CLP, EU Cosmetics Regulation, etc.).
- Proficiency in preparing regulatory documents and responding to agency queries.
- Familiarity with quality management systems (ISO 13485/ISO 9001/ISO 22716 depending on industry).
Equal Opportunity Employer
As a multi-category organization which caters to a wide range of customers across geographies; we believe a diverse workforce is an essential asset to cater to the business environment we operate in.
As an equal opportunity employer, We at Dabur don't support and accept any kind of discrimination on the ground of colour, race, age, gender, religion, nationality, marital status, sexual orientation, etc. We promote and practice equal opportunities for every member of the Dabur family.
