Regulatory Affairs Consultant

Posted 5 Days Ago
Be an Early Applicant
Long Island City, New York, NY, USA
In-Office
Entry level
Pharmaceutical
The Role
Support global market access by preparing and maintaining regulatory dossiers and registration documentation; manage registration tracking databases; coordinate with affiliates, law firms, R&D, and marketing; obtain Certificates of Free Sale and other market-specific documents to meet launch timelines and compliance.
Summary Generated by Built In

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. 
The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step.  Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

 

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.

Skills Required

  • Experience supporting global market access and preparing regulatory product dossiers
  • Ability to assemble registration documentation (formulas, specifications, Certificates of Free Sale, claims substantiation, artwork)
  • Experience maintaining registration tracking databases and ensuring data integrity
  • Experience liaising with affiliates, law firms, distributors, trade associations, and health authorities
  • Ability to coordinate data requests with R&D and Regulatory Compliance (efficacy reports, durability reports)
  • Experience managing product registration at SKU or family level and handling artwork/country-of-origin research
  • Strong communication, follow-up, and project coordination skills to meet market launch timelines
  • Experience in pharmaceutical, biotechnology, medical device, or consumer health regulatory affairs

ClinChoice Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ClinChoice and has not been reviewed or approved by ClinChoice.

  • Flexible Benefits Flexible arrangements, including telecommuting and flextime with no core hours in some regions, are highlighted for many roles. Feedback suggests flexibility is commonly available but depends on role and location.
  • Leave & Time Off Breadth Vacation, personal, and sick days are part of the core package, with some markets granting paid leave from the date of hire. Feedback suggests time off is standard-to-decent across locations, though specifics vary.
  • Healthcare Strength Health coverage is positioned as a core benefit, with some accounts describing overall benefits as full or good. In the U.S., healthcare sits within a conventional CRO package alongside medical, dental, and vision.

ClinChoice Insights

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The Company
HQ: Fort Washington, PA
5,000 Employees
Year Founded: 1995

What We Do

ClinChoice is a global full-service Contract Research Organization (CRO) specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies, aiming to accelerate the development and commercialization of innovative drugs and devices.

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