Regulatory Affairs Associate Consultant

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 a Regulatory Affairs Associate Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality professional development and supportive culture. As a client-facing role we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Main Job Tasks and Responsibilities:

• Preparation compilation and coordination of high-quality regulatory submissions for new product launches product updates and throughout product lifecycle.

• Ensure that documents to be submitted to health authorities are ready by ensuring quality review is performed before forwarding to client regulatory personnel.

• Research draft and assemble the documents required to secure export certificates market specific product applications/ notification and health authority clearances

• Support for CMC dossier preparation and review

• Review of artwork changes and associated change controls including tracking of deliverables.

• Monitoring of new and changing regulatory standards and dissemination of information.

• Support coordination of label change initiation label reviews and changes in accordance with regional /country review system and procedure.

• Provide regulatory input review and approval related to change control

• Support product portfolio through execution of legal document activities as required

• Coordination with cross functional teams for collating labels and COA’s of API excipients and finished product.

• Coordination with cross functional teams manufacturing site and local affiliates for the required information to process the documents

• Search different internal tools for the required information to process the documents.

• Preparation and compilation of regulatory documentation for submission to local country

• Develop and manage regulatory action item tables for country specific requirements

• Mapping coordination of regulatory inputs and timing end to end for country requirements resulting from legal entity change e.g. documentation required timelines for registrations/notifications and phase-in of changes to meet compliance requirements

• Communicate internally and monitoring deliverables ensuring country requirements are met by specified timeframes

• Record and publish meeting notes. Incorporate follow-up items to project deliverable tracking ongoing monitoring and issue escalation to client local managers.

• Manage regulatory action item (task) tables including mapping coordination of regulatory inputs and timing

• Work with client regulatory managers to develop project implementation plans and manage workload planning to ensure on time completion of projects and tasks

• Support client regulatory managers in their registration procedure

• Complete market impact assessments

• Generation of databases and checklists for project monitoring

• Support in the creation of product history and archives

• Company systems update

• Provision of weekly updates (at a minimum) to relevant client regulatory managers

• Ensure regulatory standards and timelines are met

• Plan and track the status of ongoing regulatory projects

• Regulatory action item tables for country specific requirements and importation/ exportation needs for change in legal entity

• Presentation materials for management updates

• Ensuring documents for health authority are submission-ready

• Supporting coordination of label change initiation label reviews and changes in accordance with regional /country review system and procedure.

• Regulatory input review and approval related to Change Control.

Education and Experience:

• Regulatory professional with formal college or higher education in science related discipline

• Relevant work experience with minimum 3+ years in regulatory affairs

• Individuals must have fluency of English and local language.

• Good understanding of local regulations for OTCCosmetics and Medical devices

• Strong working knowledge of Microsoft Word Excel Power Point

• Good communication and follow up skills with country regulatory liaisons for clear understanding of country specific needs for registrations license updates and import/export 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 4000 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.

Key words: Regulatory Affairs OTC Cosmetics Labeling Products

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