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Senior Director, Regulatory Affairs

Posted on Apr 5, 2021 by Medpace Holdings, Inc.

Cincinnati, OH 45245
Research
Immediate Start
Annual Salary
Full-Time


Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based Sr. Director, Regulatory Affairs 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 INDs, updates to INDs, 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 (eg 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: 10-20%




Reference: 1152694548

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