Regulatory Affairs Associate Consultant - Labeling

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:

We are seeking a motivated individual to join our Regulatory Affairs team as an Entry-Level Regulatory Labeling Specialist. In this role you will play a crucial part in ensuring compliance with regulatory requirements related to product labeling. This position offers an excellent opportunity for recent graduates with an advanced life science degree (PharmD PhD MD or DVM) to gain valuable experience in a dynamic and growing industry.

• Assist in the development review and maintenance of product labeling documents including package inserts patient leaflets and prescribing information in accordance with regulatory guidelines and standards.

• Collaborate cross-functionally with Regulatory Affairs Clinical Development Medical Affairs and other departments to gather necessary information for labeling activities.

• Participate in labeling-related meetings and provide input on labeling strategies including proposed changes and updates.

• Support regulatory submissions by preparing labeling documents and ensuring compliance with relevant regulations and guidelines.

• Monitor regulatory requirements and industry trends related to labeling and communicate updates to the team.

• Assist in the coordination of labeling-related projects and initiatives as needed.

• Manage timelines and client expectations by clearly understanding and communicating requests.

Education and Experience:

• Advanced degree (PharmD PhD MD or DVM) in Pharmacy Life Sciences or a related field.

• Strong attention to detail and organizational skills with the ability to manage multiple tasks and prioritize effectively.

• Excellent written and verbal communication skills with the ability to convey complex information clearly and concisely.

• Ability to work both independently and collaboratively in a team environment.

• Familiarity with regulatory requirements and guidelines related to product labeling is preferred but not required.

• Ability to understand and interpret regulatory and technical documents.

• Self-starter with an ability to work in team environment and on problems of diverse scope where analysis of a situation or data requires evaluation of various factors with minimal supervision

• Strong critical thinking and analytical skills

• Proficient in oral and written communication and in Microsoft Office (Word Excel PowerPoint Outlook) with good planning and organization skills

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 Regulatory Compliance Regulatory Labeling Clinical Development Life Science

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