Regulatory Affairs Associate Consultant - Project Coordinator

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:

• Coordinate regulatory projects from initiation to completion ensuring adherence to timelines and milestones.

• Assist in the preparation and submission of regulatory documents including applications reports and filings.

• Monitor regulatory developments and communicate updates to relevant stakeholders.

• Maintain regulatory documentation and ensure accuracy and completeness.

• Collaborate with cross-functional teams to gather information and support regulatory activities.

• Participate in regulatory meetings and provide support as needed.

• Assist in the preparation of responses to regulatory agencies and support regulatory inspections as required.

• Contribute to process improvement initiatives to enhance regulatory compliance efficiency and effectiveness.

• Participate in Global Planning Meetings to get update of upcoming demand/ planned requests. Share the anticipated demand with stakeholder (fulfillers Point of Contact)

• Receive requests in Triage and allocate them according to the guidelines. Facilitate discussions on due dates and manage communication with requesters to ensure adherence to the agreed-upon plan.

• Allocate the requests to the fulfillers team provide assistance wherever needed.

• Prepare/review and coordinate routing of documents requiring Company’s representative’s signatures

• Coordinate notarization apostille and/or legalization of regulatory documents as necessary

• Ensure accuracy checks and consistency of documents intended for submissions

• With minimal oversight prepare and review different letters used for submission

• Provide assistance with data/document/information retrieval from searching through internal Company tools.

Education and Experience:

• Bachelor's degree in a related field (e.g. regulatory affairs life sciences chemistry biology).

• Minimum of 1 year of experience in regulatory affairs or a related role.

• Strong understanding of regulatory requirements and processes.

• Excellent organizational and time management skills.

• Attention to detail and ability to manage multiple priorities simultaneously.

• Strong written and verbal communication skills.

• Ability to work independently and collaboratively in a fast-paced environment.

• Proficiency in Microsoft Office Suite and regulatory software/tools (e.g. regulatory databases document management systems) preferred.

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 Project Coordinator Project Management Regulatory Compliance Regulatory Submission.

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