Regulatory Affairs Consultant

ClinChoice•Holtsville, NY

2d•Hybrid

About The Position

This position is directly responsible for supporting global market access including ensuring products dossiers address regulatory requirements (both existing and emerging). The role involves assembling all necessary technical and registration documentation in conformity with legal regulations of the marketing countries to meet local on counter dates. It also includes coordinating and ensuring the maintenance of Brand/Market Registration Tracking databases in cooperation with affiliate, law firm and distributor counterparts, ensuring consistency and timely registrations and data integrity. The consultant will 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. Partnering with a seasoned mentor, the role provides appropriate support and follow-up with markets to secure registration and achieve market launch timelines. Maintaining and updating registration databases is crucial for end-to-end registration compliance and consistency. Regular follow-up with markets ensures accuracy of data and compliance with expiry/re-registration timelines. The position interfaces with trade associations and health authorities to secure brand/product and market specific Certificates of Free Sale. It also coordinates additional data and information requests with R&D and Regulatory Compliance, obtaining efficacy reports to support product registration, package claims and durability reports. Liaising with brand GBSC and Marketing to track and obtain final product/shade names and codes, and performing 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, are also key responsibilities.

Requirements

Directly responsible for supporting global market access.
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.

Responsibilities

Supporting global market access including ensuring products dossiers address regulatory requirements (both existing and emerging).
Assembling all necessary technical and registration documentation in conformity with legal regulations of the marketing countries in order to meet local on counter dates.
Coordinating and ensuring maintenance of Brand/Market Registration Tracking databases in cooperation with affiliate, law firm and distributor counterparts, ensuring consistency and timely registrations and data integrity.
Researching, generating and distributing registration documentation; including formulas, specifications, Certificates of Free Sale, durability, claims substantiation, supporting declarations and artwork – according to specified local market regulations.
Providing appropriate support and follow-up with markets to secure registration and achieve market launch timelines.
Maintaining and updating registration databases in order to ensure end-to-end registration compliance and consistency.
Providing regular follow-up with market to ensure accuracy of data and compliance with expiry/re-registration timelines per market.
Interfacing with trade associations and health authorities to secure brand/product and market specific Certificates of Free Sale.
Coordinating additional data and information requests with R&D and Regulatory Compliance, obtaining efficacy reports to support product registration, package claims and durability reports.
Liaising with brand GBSC and Marketing to track and obtain final product/shade names and codes.
Performing 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.