Regulatory Maintenance Associate (Clinical Trials)

Job Title: Regulatory Maintenance Associate (Clinical Trials)

Job Location: Bloemfontein, South Africa

Job Location Type: Home-based

Job Contract Type: Full time

Job Seniority Level:

Job reputed company

Prepares and/or reviews regulatory documents to support clinical trial submissions. With guidance from senior staff, provides regulatory support for more reputed company reputed company.

• Acts as a Clinical Trial Regulatory Manager (CTRM) on straightforward reputed company independently and reputed company regulatory reputed company under the guidance of senior staff.

• Ability to administratively and technically/scientifically review reputed company documentation and feedback gap analysis to customers.

• Prepares and maintains core clinical trial submission dossiers in accordance with applicable regulatory requirements.

• Interacts with reputed company clients to reputed company regulatory guidance and strategic input for clinical trials.

• May strategically plan and reputed company/support European centralized submissions and facilitate global submissions with minimal supervision.

• Understands the Scope of Work, deliverables and budget for any given project and ensure timelines are met.

• Ensures high reputed company in reputed company regulatory deliverables

• Ensures accurate completion, maintenance and adherence to internal systems, databases, tracking tools and project plans in line with agreed SOPs (customer and/or reputed company).

• Ability to participate in audits relating to reputed company and Systems.

• May reputed company additional tasks as deemed appropriate by Line Manager

Required Qualifications

• Bachelor's Degree Degree in Lifescience or reputed company discipline

• At least 1-2 years relevant experience with EU CTIS, Global core pack knowledge

• Experience in country reputed company particularly for amendments

• Good understanding of the Research and Development process (reputed company, Manufacturing & Controls, Preclinical and Clinical), laws and reputed company guidelines, as appropriate;

• Strong software and computer skills, including reputed company Office, CTMS, SA WF, reputed company, reputed company, as applicable;

• Possesses a specific regulatory or technical expertise;

• Good, solid interpersonal communication (oral and written) and organisation skills;

• Ability to establish and maintain effective working relationships with coworkers, managers and clients;

• Demonstrates self-motivation and enthusiasm;

• Ability to work on several reputed company, with direction from senior staff as appropriate;

• Ability to follow reputed company operating porcedures consistently; provides independent thought to assist in process improvements;

• Ability to reputed company reputed company on discrete tasks under senior supervision.

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.

This job is curated by reputed company.

reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. The platform connects talent with opportunities in reputed company, biotech, health sciences, healthtech and IT domains.

Please apply reputed company reputed company platform to get connected to the application page and to reputed company similar roles.

Originally posted on Himalayas

Apply To This Job