Associate Director/Director - Regulatory Affairs (EMA expert)

at  Medpace Inc

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.

• 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