Director Regulatory Affairs Operations

12/15/21

Columbus, OH

1511

Description:

To provide leadership, coaching and mentoring for the Regulatory Affairs Operations Team. Leads the timely activities related to Labeling, AdPromo, Publishing and REMS that comply with FDA requirements and lead to timely FDA approvals. Ensures that all regulatory requirements are completed on time and in accordance with FDA guidances, policies and regulations. Provides regulatory direction and strategic oversight for these operations for both commercial and developmental projects to all functions.

Responsibilities

  • Provides direction for regulatory activities for both pre and post approval commitments which comply with all regulations while meeting business needs.
  • Influences with respect to strategies and critical project issues to positively impact project goals, objectives and ultimately FDA approval.
  • Mentors, leads, coaches and develops employees; manages and addresses performance issues; and makes hiring, firing and compensation decisions to ensure individual and organizational performance currently and in the future.
  • Ensures right first time compliance with regulatory submissions made to the FDA and that internal policies and procedures, 21 CFR, FDA guidance’s, and other customer requirements are met. Responsible for ensuring site compliance with PDUFA and GDUFA regulations including educating other departments on requirements.
  • Communicates and provides advice to other functional areas to identify and implement activities to support project goals, milestones, corporate goals and objectives.
  • Communicates updates to senior management and the site regarding submissions, reviews and approvals.
  • REMS Specific: Provides oversight for the development and implementation of Risk Evaluation and Mitigation Strategy (REMS) programs. This includes alignment of organizational goals associated with the continuous operation of REMS and strategic direction to ensure compliance in this area.
  • Labeling/AdPromo Specific: Serves as the labeling and AdPromo lead for all related topics for Hikma products. Leads labeling and AdPromo strategies and leads/contributes to presentations on labeling and AdPromo related topics internally and externally. Contributes to continuous improvement initiatives and reviews/comments on related emerging regulatory guidelines/requirements. Ensures that all required internal and external timelines and deadlines are met appropriately.
  • Publishing Specific: Leads the production of high-quality submissions utilizing submission-ready documents that adhere to internal and external electronic guidelines. Ensures submissions meet the level of integrity required for Hikma and health authority validation tools. Assists submission project teams with the identification of submission-ready content requirements and applicable timeline milestones for execution of right-first-time submissions
  • Administration Specific: Provides oversight for RA administrative activities including policy, training, project management, consultations, metrics reporting, deficiency trending/mitigation and FDA negotiation/communication.

Qualifications

  • BS, MS or PhD degree in Health Sciences, Chemistry, or Pharmaceutics required.
  • Minimum 6-8 years of generic cGMP/GLP pharmaceutical experience in Regulatory Affairs, with 3-5 years of supervisory experience leading professional employees.
  • Minimum of 10 years progressive managerial experience in Pharmaceutical or related highly regulated industry (chemical, food, or other similarly-regulated environment) preferred.
  • Demonstrated ability to motivate and develop staff to be open to and seek creative alternatives to pursuing innovative solutions to regulatory challenges.
  • Extensive knowledge of drug development and regulatory processes for ANDAs, NDAs and 505(b)(2)s for both pre and post filing activities and working knowledge of clinical/bioequivalence studies and devices.
  • Demonstrated ability to analyze large data sets and apply sound scientific judgment to support conclusions and recommendations for submissions and responses to FDA.
  • Demonstrated ability to recognize issues or potential barriers, define a problem, identify underlying principles, reasons, or facts, determine appropriate solutions, and utilize resources to drive improvements of medium to high complexity.
  • Must possess strong project management skills with the ability to plan, organize, and multi-task in order to meet deadlines.
  • Requires the ability to shift thought processes quickly and accurately from one project to another.
  • Demonstrated experience mentoring, coaching, and leading others.
  • Must possess strong presentation skills, meeting facilitation skills, ability to influence others by presenting alternative options persuasively, and negotiate with internal teams and external government agencies.
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