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Director, Regulatory Affairs - CMC Job in Cincinnati, Ohio US
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Job Summary

Company
Medpace, Inc.
Location
Cincinnati, OH
Industries
Government and Military
Job Type
Full Time
Employee
Years of Experience
7+ to 10 Years
Job Reference Code
43361230

Director, Regulatory Affairs - CMC

About the Job

Director, Regulatory Affairs - CMC



Job Locations

United States-OH-Cincinnati






Category


Regulatory Affairs



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 approximately 3,500 people across almost 40 countries.



Job Summary





Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based or home-based Director, Regulatory Affairs - CMC to join our 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.



Responsibilities





Manage relationship with international regulatory agencies;
Provides program oversight and CMC regulatory strategy in various stages of development;
Demonstrates leadership and comprehensive understanding of CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to identify, communicate, address, and overcome challenges that arise during development;
Plan, review, approve required documents from various departments for filing of required information to FDA, including Chemistry, Manufacturing, and Controls (CMC) reports and CMC sections of eCTD filings;   
Provide regulatory review of study protocols, investigator’s brochures, labeling, and integrated summary documents;
Provide regulatory advice and guidance to project teams to ensure submissions meet regulatory requirements; and
Maintain up-to-date knowledge of regulatory requirements and CMC.



Qualifications





Master’s Degree or higher in Pharmacy, Chemistry, Biochemistry, or a related field, or a suitable professional degree (i.e. PharmD);
At least 8 years of global drug development experience in the CRO, Biotechnology or Pharmaceutical industries working in CMC;
Strong computer skills, project management skills, and a high attention to detail; and
Strong communication skills (both written and oral).
Must be a team player

Travel: Less than 10%



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 historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next:

A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.

*WARNING: Please beware of phishing scams that offer opportunities with Medpace in exchange for sending money.  These scammers pose as legitimate employees from actual companies.  Please be advised that a Medpace employee will never ask you for a credit card, send you a check, or ask you for any type of payment as part of consideration for a role with our company. All of our careers require that you first complete an online application and go through some sort of interview process.

EO/AA Employer M/F/Disability/Vets
 

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