Regulatory Affairs Consultant

Socket.dev; Long Island (KS); On-site; USD 89,000 - 134,000; Part time

Job summary

ClinChoice in New York is seeking a Regulatory Affairs Consultant for a 3-month hybrid contract to support global market access and regulatory submissions.

You will assemble technical dossiers, coordinate registration activities across markets, interact with R&D, Compliance, and external partners, and help secure timely product registrations and launches.

Qualifications

• Experience supporting global regulatory submissions.
• Knowledge of regulatory requirements across multiple markets.
• Ability to assemble and manage technical regulatory documentation.

Responsibilities

• Assemble and maintain regulatory documentation for market submissions.
• Coordinate registration activities with affiliates, law firms and distributors.
• Liaise with R&D, Compliance and Brand teams to secure data support and market approvals.
• Support timely product registrations and market launches across regions.

Skills

Regulatory affairs

Documentation management

Dossier coordination

Stakeholder coordination

Job description

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for an Regulatory Affairs Consultant Hybrid for 3 months Contract to join one of our clients.

Job Description:

This position is directly responsible for supporting global market access including ensuring products dossiers address regulatory requirements (both existing and emerging).

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.

Who will you be working for?

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.

Our 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 and 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.