Regulatory Affairs Consultant

This position is directly responsible for supporting global market access including ensuring products 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 in order 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 seasoned mentor to provide appropriate support and follow-up with markets to secure registration and achieve market launch timelines.
• Maintain and update registration databases in order to ensure end-to-end registration compliance and consistency.
• Provide regular follow-up with market 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 action and 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. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

Company Ethos

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 the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built. Close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

Schedule

• Hybrid work arrangement
• 3-month contract