Associate Director/Director - Regulatory Submissions

MEDPACE

London , United Kingdom

6d ago

Associate Director / Director - Regulatory Submissions (Technical Advisors)

Job Locations United Kingdom-London France-Lyon Poland-Warsaw

Job Summary

Our corporate activities are growing rapidly, and we are currently seeking a full-time Director / Associate Director to join our Regulatory Advisors team within the Regulatory Submissions department.

Possessing a strong clinical trial regulatory affairs background, you will support the submissions team and wider company in a wide range of regulatory activities and projects.

The successful candidate will also assist with the strategic development and management of the Advisors team and identify and support continuous process improvement.

Location flexible within Europe, home-based or flexible working options considered.

Responsibilities

Providing regulatory submissions strategic advice, guidance, support and planning to Sponsors and Medpace project teams;

Reviewing and interpreting regulations and guidance to develop proactive solutions to regulatory issues and challenges;

Developing and reviewing core regulatory submission documents to ensure compliance with global regulations;

Assisting in maintenance of Medpace regulatory intelligence systems;

Overseeing hiring, training, evaluation and retention of employees;

Identifying and implementing process improvements;

Supporting business development activities including proposal review and bid defences.

Qualifications

Bachelor’s degree in Life Sciences or a related field; Advanced degree preferred

At least 10 years job related experience; appointment commensurate with experience

Demonstrated global clinical trial regulatory affairs experience;

Strong computer skills, project management skills and a high attention to detail;

Excellent communication skills (both written and oral);

Excellent presentation, negotiation, leadership and interpersonal skills;

Experienced in line management and team leadership;

Must be a team player with a global regulatory mind-set.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV 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 its scientific and disciplined approach.

We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.

Headquartered in Cincinnati, Ohio, employing more than 4,000 people across almost 40 countries.

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