Head of Regulatory Affairs

Company: Medpace
Location: Cincinnati
Posted on: September 14, 2020

Job Description:

Head Compliance Officer Jobs in Cincinnati, OH. 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 Head of Regulatory Affairs to join our team. This position is accountable for leading 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 individual in this role 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 to lead the Regulatory Affairs organization in the development and implementation, at a 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;. Leads the development and implementation of innovative strategies to maximize the likelihood of regulatory success;. Leads the oversight and accountability for global regulatory operations;. Leads and represents Medpace regulatory professionals and subject matter experts;. Oversees all project related regulatory strategy with all global project teams;. Assures compliance with project team timelines and milestones for global regulatory deliverables;. Oversees and is accountable for the effective planning, organizing, and conduct of formal meetings with regulatory agencies including advisory committee meetings, oral explanations and other scientific and development meetings;. Leads regulatory strategic development, communication and updates and ensures appropriate consultation and peer review;. Leads and monitors changes in the regulatory environment, both general and specific to the therapeutic area and support and advise teams and department staff accordingly;. Provides regulatory leadership as needed in early development and due diligence review projects;. Participates in skill-development, coaching, and performance feedback of other regulatory staff working on the product/project;. Manages relationships with competent authorities through frequent interaction;. Collaborates with EU regulatory to develop global approval strategies;. Provides regulatory advice and guidance to project teams to ensure submissions meet regulatory requirements;. Maintains up-to-date knowledge of regulatory requirements. Represents department/functional area in Business Development, including reviewing proposals and participating in general capabilities and bid defense meetings;. Oversees supervision, development, and mentorship of regulatory personnel; and. Responsible for cultivating a high performing regulatory team focused on accountability and meeting and exceeding expectations. Qualifications. Advanced degree required. Preferred degrees include, PharmD, MD, and/or PhD. Other degrees and backgrounds may be considered;. Minimum of 15 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: 15-20%. 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.. 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.. Get alerts to jobs like this, to your inbox.

Keywords: Medpace, Cincinnati , Head of Regulatory Affairs, Other , Cincinnati, Ohio