Regulatory Affairs Consultant
This position is directly responsible for supporting global market access, including ensuring product dossiers address regulatory requirements (both existing and emerging).
Responsibilities
- Assemble (gather/create) all necessary technical and registration documentation in conformity with legal regulations of the marketing countries to meet local on-counter dates.
- Coordinate and ensure maintenance of Brand/Market Registration Tracking databases in cooperation with affiliate, law firm, and distributor counterparts, ensuring consistency and timely registrations and data integrity.
- Research, generate, and distribute registration documentation—including formulas, specifications, Certificates of Free Sale, durability, claims substantiation, supporting declarations, and artwork—according to specified local market regulations.
- Partner with a seasoned mentor to provide appropriate support and follow-up with markets to secure registration and achieve market launch timelines.
- Maintain and update registration databases to ensure end-to-end registration compliance and consistency.
- Provide regular follow-up with markets to ensure accuracy of data and compliance with expiry/re-registration timelines per market.
- Interface with trade associations and health authorities to secure brand/product and market-specific Certificates of Free Sale.
- Coordinate additional data and information requests with R&D and Regulatory Compliance, obtaining efficacy reports to support product registration, package claims, and durability reports.
- Liaise with brand GBSC and Marketing to track and obtain final product/shade names and codes.
- Perform research with brand and/or PDS to obtain all variant/kit/set/size artwork and country-of-origin information required to complete product registration on a SKU and/or family level, depending on market requirements.
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. With over 28 years of proven high-quality delivery and results, ClinChoice employs over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are our most valuable asset, and we invest in their growth through continuous training to maintain highly qualified personnel. This approach keeps our resources competent and ensures they have the tools needed to manage both internal and client processes effectively.
ClinChoice is an equal opportunity employer. We celebrate diversity and inclusivity, recognizing that our strength lies in the varied backgrounds—gender, race, beliefs, and ethnicities—of our employees.