Director Regulatory Affairs, CMC

12/15/21

Columbus, OH

1510

Description:

To provide leadership, coaching and mentoring for the Regulatory Affairs department. Leads the timely filing of new multisource products that comply with FDA requirements and lead to timely FDA approvals. Ensures that all regulatory requirements for lifecycle products are completed on time and in accordance with FDA guidance’s, policies and regulations. Provides regulatory direction and strategic oversight for all submissions 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.
  • CMC Specific: Leads the CMC teams (development and lifecycle) to ensure the strategic management and timely communication, feedback and follow-up with the FDA, internal and external partners and executive management regarding regulatory submissions, deficiency responses and approvals.
  • 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 required.
  • 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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