West-Ward Pharmaceuticals

  • Director, Regulatory Affairs and Labeling

    Job Location US-OH-Columbus
    Posted Date 4 months ago(12/19/2017 2:40 PM)
    Job ID
    2017-4177
    Job Function
    Regulatory Affairs
  • Overview

    Leads, coaches, and mentors direct reports to accomplish organizational and department priorities.

     

    Leads the West-Ward Pharmaceuticals regulatory and labeling groups in filing new multi-source products that comply with regulatory requirements in order to obtain FDA approval of West-Ward Pharmaceuticals products. Ensures that all regulatory requirements for life-cycle products are completed on time and in accordance with FDA guidances, policies and procedures. Provides regulatory direction and strategic oversight for all submissions for both commercial and developmental projects to all functions.

    Responsibilities

    • 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.

      • Communicates site and department goals and expectations to staff.

      • Sets goals and expectations for staff with their input.

      • Ensures conditions (time, equipment, etc) necessary for staff performance are met and barriers to performance are removed.

      • Measures direct reports' core job/MAG performance and contribution to team performance.

      • Communicates site and department performance to staff.

      • Provides direct reports with feedback on core job/MAG performance.

      • Collaborates with direct reports to identify and enable their skill and knowledge development.

      • Rewards and recognizes staff and team performance to build engagement.

      • Ensures direct report positions are filled timely with the best qualified candidate(s).

    • Provides strategic support and decisions for all regulatory issues regarding new ANDA/NDA filings as well as life-cycle ANDAs that are approved and marketed in the US. Influences with respect to strategies and critical project issues to positively impact project goals, objectives and ultimately FDA approval.

    • Leads the Drug Regulatory Affairs and Labeling Teams to ensure 16 to 20 new product ANDA/NDAs are filed accurately and timely through review and approval in order to support the RLI business model.

    • 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. Oversees GDUFA/PDUFA yearly budget. Makes key decisions regarding regulatory strategies and communicates and provides advice to other functional areas to identify and implement activities to support project goals, milestones, corporate goals and objectives.
    • Manages and leads all activities and interactions with the FDA and other regulatory authorities on ANDA and NDA filings and communicate updates to senior management and the site regarding the review and approvals.
    • Leads in the company’s understanding and awareness of regulatory requirements and establish policies and procedures for all regulatory filings which include review, submission and approval for all ANDAs, NDAs, supplements and AR sent to the FDA.
    • Participates and leads outside focus meetings with FDA and in order to stay ahead of the changing regulatory environment in order to identify new ideas and processes. Keeps current in the regulatory guidance’s, practices and technologies necessary for all regulatory submissions as appropriate through training, seminars and investigating new technologies. Lead in the company’s understanding and awareness of regulatory requirements by training outside departments on FDA guidances and policies including monitoring the impact of the changing regulations on current submission strategies.

    Qualifications

    • Bachelor's degree required, preferably in a scientific field.
    • MS/MSc highly preferred.
    • Minimum eight (8) years of Pharmaceutical industry experience with at least five of those years being regulatory submission experience. Must have experience interacting with OGD and CDER including teleconferences and face to face meetings.
    • At least five (5) years of supervisory experience leading professional employees.
    • Must possess thorough knowledge of federal regulations on IND, NDA and ANDA required. Comprehend, analyze, and interpret federal regulations in order to make them applicable for the business and applied appropriately.
    • Must possess strong scientific knowledge of drug development and regulatory strategies.

    WWHIGH

     

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