Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Regulatory Affairs Manager or Associate Director

Company: Medpace
Location:
Reference: PLRAM1118
Closing Date: 23 Dec 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Medpace is looking for a Regulatory Affairs Manager or Associate Director to be based in Warsaw, Poland.

Requirements:

Regulatory Affairs Manager or Associate Director

Location: Warsaw, Poland

Overview

Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach. We leverage local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,700 people across 36 countries.

Job Summary

Our corporate activities are growing rapidly, and we are currently seeking a full-time Regulatory Affairs Manager to join our Regulatory Affairs team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. 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. This is an office based position in one of the following locations: London, Stirling, Munich, Maastricht, or Warsaw

Responsibilities

  • Project management focus to facilitate full global regulatory submissions which will include:
  • Tracking, compiling, and maintaining full regulatory applications including initial INDs and NDAs;
  • Maintaining timelines for full regulatory submissions;
  • Providing regulatory advice and guidance to other Medpace department to ensure compliance with EMA regulations and requirements;
  • Interaction with EMA and other regulatory agencies;
  • Developing scientific and regulatory briefing documents for pre-IND, end of phase II, and pre-NDA meetings with the EMA; and
  • Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges

Qualifications

  • Bachelor’s degree and 7 years regulatory affairs experience, OR Master’s degree and 5 years regulatory affairs experience;
  • CMC experience preferred;
  • Experience with EMA and other regulatory agencies is preferred;
  • Strong computer skills, project management skills, and a high attention to detail;
  • Strong communication skills (both written and oral); and
  • Must be a team player with a global regulatory mindset.
  • This position may require supervision of junior level staff.

 

Travel: 10-25%

Why Medpace?

When you join Medpace, you become part of a team dedicated to supporting the development of ground breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities. 

 

Awards

  • Medpace Named a Top Cincinnati Workplace for 2015, 2016, 2017 and 2018 by the Cincinnati Enquirer
  • Winner of the ACRP-Avoca CRO Quality Award in 2018
  • Recognized with six CRO Leadership Awards from Life Science Leader magazine
  • Eagle Award winner - which recognizes outstanding leadership, professionalism, integrity, and dedication to advancing the clinical research profession through strong site partnerships

 

What to Expect Next

We look forward to receiving your application.  A member of our recruitment team will review your qualifications and if interested, you will be contacted for an interview.

Apply for this job: Regulatory Affairs Manager or Associate Director

Contact Information:

Address:  Medpace Poland Sp. z o.o.
26 Iłżecka St. Wisniowy Business Park Build. E 02-135 Warsaw, Poland

Poland
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.