Job Title: Regulatory Associate - International Regulatory Affairs
Department: International Regulatory Affairs
Reports to: Head - International Regulatory Affairs
Location: HGRC, Dubai
Position Overview
The Regulatory Associate will play a key role in supporting the global regulatory compliance and intelligence functions for the company's herbal wellness, food supplement, and cosmetic product portfolio. The role involves ensuring ingredient and formulation compliance across multiple global markets, maintaining regulatory databases, and providing timely updates on global regulatory developments that may impact the company's product strategy and operations.
Key Responsibilities- Regulatory Compliance
- Review the regulatory acceptability of herbs, botanicals, and other active ingredients across key global regions - US, EU, APAC, and GCC, to ensure compliance with local regulations.
- Evaluate excipients and other inactive ingredients for their acceptability and permissible use in pharmaceutical, nutraceutical, or cosmetic dosage forms.
- Monitor global safety alerts, market withdrawals, and updates related to herbal medicines, food supplements, and cosmetics.
- Provide technical and regulatory input for global product registration dossiers, renewals, and product claims.
- Support internal stakeholders by interpreting and applying applicable regional standards, including FDA (US), EMA (EU), TGA (Australia), SFDA (Saudi Arabia), ESMA (UAE), and ASEAN frameworks.
- Regulatory Intelligence
- Global Regulatory Monitoring:
- Continuously track and interpret emerging regulations, directives, and guidance across US, EU, APAC, and GCC for herbal, cosmetic, and supplement categories.
- Monitor updates from key frameworks such as:
- EU: Regulation (EC) 1223/2009 on Cosmetic Products, EU Novel Food Catalogue, Directive 2002/46/EC on Food Supplements, and HMPC herbal monographs.
- US: FDA DSHEA, OTC Monograph updates, California Proposition 65, and AHPA (American Herbal Products Association) alerts for botanicals.
- APAC: ASEAN Cosmetic Directive, and national authorities such as TGA (Australia), NPRA (Malaysia), HSA (Singapore), and FSSAI/AYUSH (India).
- GCC: SFDA (Saudi Arabia), ESMA (UAE), and GSO standards.
- Trade Association and External Collaboration:
- Liaise with global regulatory and trade associations (e.g., AHPA, IADSA, Cosmetics Europe, ASEAN Cosmetic Committees etc.) to gather early insights on regulatory developments.
- Participate in association forums and working groups to remain informed of regulatory interpretations, ingredient restrictions, and harmonization initiatives.
- Engage with local partners, consultants, and notified bodies to verify interpretations and confirm compliance strategies for new product markets.
- Reporting and Dissemination:
- Develop and maintain a Regulatory Intelligence Tracker summarizing new regulations, safety alerts, labeling updates, and ingredient restrictions.
- Circulate monthly or quarterly intelligence briefs summarizing:
- Ingredient-related safety alerts (e.g., RASFF, RAPEX, FDA enforcement, AHPA botanical alerts)
- Additions or changes to the EU Novel Food Catalogue
- Revised limits or banned lists for cosmetic or herbal actives.
- Coordinate with formulation, R&D, and marketing teams to communicate the impact of regulatory updates and advise on required product or documentation changes.
- Internal Communication and Strategic Input:
- Maintain a Regulatory Intelligence Library or internal dashboard providing real-time updates to key functions.
- Assist the Head of Regulatory Affairs in developing regulatory strategy briefs and impact assessments for new or revised laws.
- Establish an early warning mechanism for major regulatory transitions to enable proactive business planning.
- Regulatory Data Management
- Regulatory Alerts & Compliance Database:
- Update and manage a centralized Regulatory Alerts and Compliance Database that records ingredient-specific and product-specific compliance information.
- Capture all global regulatory alerts, market recalls, and ingredient restrictions relevant to herbal, supplement, and cosmetic categories.
- Communicate key changes to relevant teams and ensure appropriate action is taken.
- Formulation & Ingredient Compliance Review:
- Review formulation compliance requests submitted by Formulation and Phytochemistry teams for new or reformulated products. Verify herbs, excipients, colors, and preservatives against regulatory listings (e.g., EU Annexes, FDA IID, ASEAN Positive Lists) and confirm their permissible use.
- Issue written clearance or justifications, supported by regulatory or scientific references, and ensure traceability of decisions for audits.
- Support dossier compilation and product information files (PIFs) with accurate ingredient data.
- Global Collaboration:
- Collaborate with regional regulatory teams to harmonize ingredient data and compliance requirements across markets.
- Track and document country-specific variations in ingredient status, allowable limits, and labeling conditions.
- Develop regulatory dashboards and summaries to give leadership visibility into global compliance status.
- Regulatory Ingredient Database (RID):
- Maintain and continuously update the Regulatory Ingredient Database (RID) for cosmetics.
- Lead the launch and development of the RID for supplements, ensuring inclusion of ingredient identity, function, concentration limits, regional compliance, and references.
- Partner with IT/digital teams to enhance the RID platform's functionality, data integrity, and accessibility.
- Prepare quarterly updates summarizing new entries, delistings, and changes that impact product formulations.
- Documentation & Audit Readiness:
- Maintain comprehensive and traceable documentation of all regulatory communications, alerts, and database updates.
Qualifications And Experience- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Science
- Min 3 years of experience in Regulatory Affairs within pharma, herbal, nutraceutical, or cosmetic sectors.
- Working knowledge of international regulatory frameworks such as:
- FDA (US) - DSHEA, OTC Monographs
- EU - EC 1223/2009, Food Supplement Directive, Novel Food Regulation
- APAC - ASEAN Cosmetic Directive, TGA, NPRA, FSSAI/AYUSH
- GCC - SFDA, ESMA, GSO.
- Familiarity with ingredient classification, safety assessments, and technical documentation requirements.
- Experience in managing or developing regulatory databases is desirable.
Key Skills And Attributes
- Strong analytical and research skills with high diligence.
- Excellent communication, coordination, presentation, and documentation abilities.
- Proficiency in regulatory intelligence tools, database management, and MS Office / SharePoint systems.
- Ability to interpret complex regulatory information and translate it into practical guidance.
- Organized, initiative-taking, and capable of managing multiple global projects simultaneously.
