Sr. Director, Regulatory Affairs

Medpace Cincinnati , OH 45201

Posted 2 months ago

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 3,000 people across 36 countries.

Job Summary

Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Affairs Leader to join our team. This position is accountable for the development and implementation of the regulatory strategy for specific Sponsor projects, for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the team. The RAD possesses strategic leadership skills, has deep experience in North American (US and Canada) regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of therapeutic areas and drug development is an important enabler to being able to influence cross-functional discussions Sponsors and relevant stakeholders.

Responsibilities

  • Accountable for the development and implementation, at a regional or global level, of the regulatory strategy for a product/ group of products and for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the Sponsor;

  • Leads and develops a regional and/or global regulatory strategy that is reflective of applicable domestic and international requirement;

  • Conducts assessments such as regulatory gap analyses, considerations and strategy, risk planning and mitigation;

  • Lead the development and implementation of innovative strategies to maximize the likelihood of regulatory success;

  • Serves as the single point of contact with Sponsor and internal Medpace teams for select projects, with key contributing members from department staff;

  • Accountable for the delivery of regulatory milestones including assessment of the probability of regulatory success together with risk mitigation measures;

  • Accountable for post-market application maintenance and compliance activities;

  • Partner with department staff to influence developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory more generally;

  • Lead the regulatory staff working on a product/project to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality;

  • Ensure effective regulatory representation in partnership with appropriate technical experts at all health authority meetings and clear documentation of the discussion and agreements;

  • Leads regulatory strategic development, communication and updates and ensures appropriate consultation and peer review;

  • Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise teams and department staff accordingly;

  • Provide regulatory leadership as needed in early development and due diligence review projects;

  • Participate in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project;

  • Manage relationships with competent authorities through frequent interaction;

  • Plan, review, approve required documents from various departments for filing of required information to FDA, including, pre-IND and other consultations with FDA, new IND's, updates to IND's, and original/supplemental NDA filings;

  • Provide regulatory review of study protocols, investigator's brochures, labeling, and integrated summary documents;

  • Collaborate with EU regulatory to develop global approval strategies;

  • Provide regulatory advice and guidance to project teams to ensure submissions meet regulatory requirements;

  • Maintain up-to-date knowledge of regulatory requirements; and

  • Supervise, develop, and mentor regulatory personnel.

Qualifications

  • Advanced degree required. Preferred degrees include, PharmD, MD, and/or PhD. Other degrees and backgrounds may be considered;


  • 8 years of experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas;


  • Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.);

  • Broad background of experience working in pharmaceutical business;

  • Proven leadership and program management experience;

  • Ability to think strategically and critically evaluate risks to regulatory activities;

  • Ability to work strategically within a complex, business critical and high profile development program;

  • Successful contribution to a major regulatory approval at a global or regional level;

  • A scientific and clinical understanding of the regulatory sciences; and

  • Must demonstrate competencies of strategic thinking, strategic influencing, innovation, initiative, leadership, and excellent oral and written communication skills.

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 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.

EO/AA Employer M/F/Disability/Vets

  • 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.
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Sr. Director, Regulatory Affairs

Medpace