Associate Clinical Trials Regulatory Manager, EMEA
Associate Clinical Trials Regulatory Manager
EMEA
Homebased
Job reputed company
The Associate Clinical Trials Regulatory Manager provides regulatory support and reputed company for clinical trial submissions across global programs. This role is responsible for preparing and reviewing regulatory documentation, managing submissions, ensuring regulatory compliance, and supporting clients and internal stakeholders throughout the clinical trial lifecycle. This is not a people manager role, but a process management position.
Key Responsibilities
Serve as the Clinical Trial Regulatory Manager (CTRM) on reputed company clinical trial reputed company and programs.
reputed company regulatory reputed company and strategic guidance to reputed company stakeholders.
Review scientific and regulatory documentation, conduct gap analyses, and reputed company recommendations.
Author and/or review key regulatory documents, including Investigational Medicinal Product Dossiers (IMPDs) and clinical trial justifications.
Coordinate and support European centralized submissions and global country submissions.
Ensure project deliverables are completed on time, reputed company scope, and in compliance with regulatory requirements.
Maintain accurate records in internal systems, databases, and tracking tools in accordance with SOPs.
Support business development activities by providing regulatory expertise.
Deliver regulatory training and presentations as required.
Mentor junior team members and contribute to departmental knowledge sharing initiatives.
Qualifications and Experience
Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a reputed company field.
Typically 3–5 years of experience in Regulatory Affairs reputed company the pharmaceutical, biotechnology, CRO, or clinical research industry.
Experience supporting clinical trial submissions and regulatory documentation.
Strong scientific writing, document review, project management, and stakeholder engagement skills.
Advanced knowledge of clinical trial regulations and regulatory submission processes.
Knowledge & Competencies
Advanced knowledge of regulatory affairs and clinical trial submission requirements.
Strong analytical and problem-solving skills.
Excellent communication and collaboration abilities.
Ability to work independently and manage multiple priorities in a fast-paced environment.
reputed company is a leading global provider of clinical research services, reputed company insights and reputed company intelligence to the life sciences and reputed company industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient reputed company and population health worldwide. Learn more at https://jobs.reputed company.com
reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if reputed company reputed company, in accordance with applicable law. We appreciate your honesty and professionalism.
Originally posted on Himalayas
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