Associate Director/Director – Regulatory Affairs (EMA expert)

Job title:

Associate Director/Director – Regulatory Affairs (EMA expert)

Company:

Medpace

Job description

Job Summary :Medpace is the leading CRO for Biotech companies that has continued its growth year-over-year. We are currently seeking a full-time Director / Associate Director, Regulatory Affairs to join our team. This position will lead & manage interactions with the European Medicines Agency (EMA) and provide strategic input into the global drug development plans of our clients. The ideal candidate possesses strategic leadership skills, has deep experience interacting with the EMA, and expert knowledge of global drug development processes and strategies. Responsibilities :

  • Provide expert regulatory strategy to satisfy expected industry standards, applying in-depth knowledge of regulatory requirements and guidelines, procedures, and agency precedent;
  • Advise project teams regarding the development and implementation of regulatory strategy throughout the clinical development processes;
  • Collaborate across development teams on strategic projects including gap analyses, meetings with regulatory authorities, protocol synopsis development and review, and other strategic deliverables;
  • Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate;Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges;
  • Interact with the appropriate national/regional government regulatory agencies; and
  • Provide regulatory advice and guidance to Clinical Operations, Medical Writing, Clinical Safety/Pharmacovigilance, Data Management, and Biostatistics.

Qualifications :

  • MD, PhD in Life Sciences, or other advanced degree;
  • Minimum of 5 years of experience or equivalent of regulatory drug development. Expert knowledge of regulatory affairs within one or more therapeutic areas;
  • Professional experience working at the EMA such as within a scientific committee, preferred; and
  • Extensive experience working/partnering with the EMA required.

Travel: Less than 10%. 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 5,000 people across 40+ countries. Why Medpace? :

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.Medpace Perks
  • Hybrid work-from-home options (dependent upon position and level)
  • Competitive PTO packages
  • Company-sponsored employee appreciation events
  • Employee health and wellness initiatives
  • Flexible work schedule
  • Competitive compensation and benefits package
  • Structured career paths with opportunities for professional growth

Awards

  • Recognized by Forbes as one of America’s Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect NextA Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.EO/AA Employer M/F/Disability/Vets

Expected salary

Location

Louvain, Brabant Flamand

Job date

Sat, 10 Aug 2024 03:24:17 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesineu.com) you saw this job posting.

Share
yonnetim

Published by
yonnetim
Tags: phd

Recent Posts

Sales Manager

vacanciesineu.com Mandarin Oriental, Lago di Como aims to become one of the most exclusive resorts…

2 minutes ago

Tecnico di laboratorio veterinario – part time

vacanciesineu.com In qualità di Lab technician presso IDEXX, sarai un contributore chiave presso una delle…

2 minutes ago

Hitrac Engineering Group – Contract Support Sicurezza – Roma in Rome Lazio, Italy

vacanciesineu.com Hitrac Engineering Group - Contract Support Sicurezza - Roma Job ID 195092 Posted 22-Nov-2024…

2 minutes ago

Quality Technician

vacanciesineu.com Description Build your Career with an Industry Leader  Join the new MCC and you…

2 minutes ago

SAFETY SPECIALIST

vacanciesineu.com Description Principali responsabilità Supporta attivamente i programmi di miglioramento continuo, promuovendone la cultura della…

2 minutes ago

Senior Creative Designer

vacanciesineu.com Company Description Publicis Groupe: win in the platform world! LePub is part of Publicis Groupe, the world’s third largest communications group.  What can we do as Publicis Groupe?  Known for…

2 minutes ago
If you dont see Apply Button. Please use Non-Amp Version