Experienced Regulatory Submissions Coordinator

Medpace; United States; Remote; USD 18,000 - 33,000; Full time

Benefits offered by this job

WFH flexibility

Job summary

Medpace is seeking a full-time, remote Regulatory Submissions Coordinator to support our Clinical Operations team in South Africa. The role focuses on preparing, reviewing, and filing regulatory submissions, coordinating with research sites, and ensuring adherence to regulations and timelines.

Ideal candidates will have a life sciences degree, at least one year of experience, strong organizational and communication skills, and proficiency with Microsoft Office and regulatory documentation

Qualifications

• Bachelor's degree preferably in life sciences
• At least one year of experience
• Excellent organization and communication skills
• Knowledge of Microsoft Office
• Hands-on experience preparing, reviewing, and submitting regulatory documentation
• Very good knowledge of English

Responsibilities

• Prepare, review, and file clinical trial applications to domestic and international regulatory agencies
• Communicate with research sites in South Africa
• Ensure submissions comply with applicable regulations and guidance documents
• Advise sponsors on changing regulations and compliance requirements
• Track submissions and ensure timely filing of documents
• Provide support for feasibility

Skills

Bachelors in Life Sciences

Organizational skills

Communication skills

Microsoft Office

Regulatory submissions

English proficiency

Education

Bachelor's degree in life sciences

Job description

Our clinical activities are growing rapidly, and we are currently seeking a full-time, remote Regulatory Submissions Coordinator to join our Clinical Operations team in South Africa. This position plays a key role in the clinical trial management process at the company. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

• Prepare, review, and file clinical trial applications to domestic and international regulatory agencies;
• Communicate with research sites in South Africa;
• Ensure submissions comply with applicable regulations and guidance documents;
• Advise sponsors on changing regulations and compliance requirements;
• Track submissions and ensure timely filing of documents; and
• Provide support for feasibility.

Qualifications

• Bachelor's degree preferably in life sciences;
• At least one year of experience;
• Excellent organization and communication skills;
• Knowledge of Microsoft Office; and
• Hands-on experience preparing, reviewing, and submitting regulatory documentation;
• Very good knowledge of English.

Travel: NoneWe kindly ask to submit applications in English. We would appreciate if you could indicate the status of your work permit if needed.

the company Overview

the company is a full-service clinical contract research organization (CRO) providing phase l-lV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why the company?

When you join the company, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

• Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellenceCollaborative Culture

• Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
• Leadership throughout the company is both accessible and approachable

Continuous Growth & Development

• Office based environment with on-site mentors
• Defined career paths with clear advancement opportunities
• Industry renowned onboarding and training programs designed to accelerate professional development
• Ongoing training and continuous learning opportunities throughout your career
• An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee Benefits

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events

Please note benefits may vary based on country.

What to Expect NextA the company team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.

Originally posted on Himalayas