• Associate Director, Regulatory Affairs

    Job Locations US-PA-Wayne
    Posted Date 4 months ago(11/28/2018 3:31 PM)
    Job ID
    2018-1234
    # of Openings
    1
    Category
    Research & Development
  • Overview

    We are Aclaris Therapeutics – committed to meeting the needs of patients with skin and hair conditions with innovative treatments that define new standards of care in dermatology and immunology.  Reporting to the Sr.Director, Regulatory Affairs this position will be responsible for regulatory activities supporting the development of NCEs globally.

    Responsibilities

    • Manages regulatory projects and submissions.
    • Ensures all necessary applications are filed and maintained in compliance with applicable regulations.
    • Leads and directs the work of others as part of a matrixed organization.
    • Provides regulatory oversight for assigned projects, focused on nonclinical and clinical aspects of drug development and the regulatory maintenance of marketed products.
    • Reviews advertising and promotional materials.
    •  Coordinates and is accountable for all Health Authority submissions and approvals within therapeutic area of responsibility.
    • Coordinates interactions with and submissions to Health Authorities. Communicates effectively the outcome of Health Authority interactions and provides analyses of potential impact.
    • Ensures compliance with both internal Aclaris process and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.
    • Acts as US regulatory content and procedural subject matter expert to internal stakeholders on matters related to regulatory and drug development. Provides a regulatory strategic focus on nonclinical and clinical aspects of drug development, mareketed products, and associated regulations and guidance.
    • Accountable for overall content and management of regulatory components and filings i.e. NDA/BLAs, INDs. Contribute to overall strategy and content for local label development.
    • Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.
    • Actively participate as member of Project Teams supporting products.
    • Responsible for US and ex-US specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements.
    • Leads and manages health authority meetings as applicable for specified projects.
    • Serves as the Regulatory expert in advertising and promotion

    Qualifications

    • BS degree, advanced scientific degree preferred.
    • A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience in drug development.
    • Preferred experience in managing filings resulting in first-time approval; or managing programs in closely related development area. Experience preparing and submitting INDs, NDAs, and labeling. 
    • Advertising and Promotional review experience preferred.
    • Relies on extensive experience and judgment to plan and accomplish goals.
    • Understands and interprets complex scientific issues across projects and area(s) of responsibility as the issues relate to regulatory requirements and strategy.
    • Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
    • Must be strong overall in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
    • Exceptionally strong in the following areas: working well with others including cross-functional teams and communication with leadership.

    Travel:

    • Willingness to travel to various meetings, including overnight trips. Some international travel may be required.
    • Requires approximately 20 % travel.

    What We Provide:

    At Aclaris Therapeutics, we are proud to offer if eligible, a highly competitive compensation plan with an excellent benefits package including the following: 

    • Company Sponsored Insurance: Medical, Dental, Vision, Life Insurance, AD&D Insurance Short-Term Disability and Long-Term Disability
    • 3 Weeks Paid Vacation
    • 14 Paid Holidays
    • 401(k) with a generous match!
    • On-site Gym with personal trainer, free for employees!
    • Fun environment!
    • Free Snacks Daily!
    • Pizza Friday – free for employees!
    • Catered lunches and other fun events!
    • Hands-on management to provide comprehensive training and professional development
    • Advancement opportunities
    • Modern office in beautiful corporate park with access to parks, shopping and restaurants

    Location:

    640 Lee Road

    Wayne PA 19087

     

    Hours:

    Standard hours

    9:00AM-5:00PM, Monday-Friday

     

     

    Aclaris Therapeutics, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity.

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