Collegium Pharmaceuticals

  • Vice President, Regulatory Affairs

    Job Locations US-MA-Canton
    Posted Date 4 weeks ago(9/26/2018 2:21 PM)
    ID
    2018-1288
    # of Openings
    1
    Category
    Regulatory Affairs & Quality Assurance
  • Overview

    Come join our team of passionate, engaged and experienced employees. Collegium Pharmaceutical is a pharmaceutical company focused on the development of innovative treatments for chronic pain. Our mission is to be the leader in responsible pain management by developing and commercializing innovative, differentiated products for people suffering from chronic pain. Based in Stoughton, MA we are a team of nearly 300 employees and growing. Come join the camaraderie of Collegium Pharmaceutical!

     

    The Vice President, Regulatory Affairs will be responsible for building, developing and leading a Regulatory Affairs department for the evolving needs of Collegium. They will report to the Chief Medical Officer and serve as a member of the Medical Legal and Regulatory Review Team.

    Responsibilities

    • Direct, control and implement all regulatory activities according to in-house specifications as well as FDA, EU and international regulations;
    • Provide expert analysis and evaluation of regulatory information;
    • Analyze and make recommendations for improving regulations and guidelines;
    • Communicate with US, European, and other international regulatory agencies;
    • Develop and maintain current regulatory knowledge and ensure that staff is aware of new and existing relevant procedures, guidance, and regulations;
    • Provide Commercial Operations Support.
    • Prepare, submit and maintain regulatory files (NDAs, supplemental NDAs, etc.) for approved products;
    • Interact with regulatory agencies to facilitate approval for product, manufacturing, and labeling changes;
    • Review marketing promotional materials and provide leadership/guidance in the development of compliant sales training, advertising and detail literature;
    • Advise Medical Liaison and Medical Communications groups regarding regulatory issues and impacts of these activities;
    • Provide regulatory input to the business development group in the assessment of new product acquisition and product out-licensing candidates; and
    • Manage post-market surveillance requirements for commercial products by assessing regulatory categorization of adverse events reported during use in the population and prepare/file expedited safety and periodic safety reports to FDA.
    • Effectively communicates with team, peers, executive management and or board of directors.
    • Encourages team to deliver tactful and actional feedback across all levels.
    • Established and manages the department budget and ensure that the department operates cost-efficiently.
    • Demonstrates cross-functional expertise and thrives in a highly complex environment.
    • Demonstrates strong analytical thinking, organizational and communication skills.
    • Works with diverse stakeholders and builds strong, collaborative relationships. Manages competing agendas and priorities across different functional departments.
    • Sets direction and focus by leveraging organizational abilities and proactive planning.

    Qualifications

    • PhD or equivalent degree in a scientific discipline and a minimum of 10 years of pharmaceutical and drug development regulatory experience as well as background in dealing with the FDA and preferably European regulatory authorities;
    • Substantial experience in all aspects of regulatory affairs, including Commercial support, CMC and Clinical and a track record of successful submissions and license approvals with CDER or CBER;
    • A thorough understanding of relevant guidance and regulations and requirements;
    • A demonstrated ability to manage regulatory activities and deliver against program timelines
    • Has exceptional qualitative and analytical/quantitative skills.
    • Demonstrates outstanding leadership capabilities, including employee coaching, objective setting, and professional development.
    • Works with diverse stakeholders and builds strong, collaborative relationships. 
    • Manages competing agendas and priorities.
    • Consistently demonstrates strategic thinking about business initiatives with an entrepreneurial spirit.
    • Exceptional verbal and written communication skills.
    • Excellent organizational, interpersonal, communication and negotiation skills;
    • RAC certification is helpful but not necessary; and
    • Software skills should include MS Excel, MS Project, MS PowerPoint, and MS Word.

     

     

    COLLEGIUM KEYS TO SUCCESS:

    • Effectively collaborates with others to reach mutually agreeable outcomes and to resolve potential conflicts.
    • Strong problem solver.
    • Exhibits dedication to helping peers succeed.
    • Encourages others to provide peer and upward feedback.
    • Manages multiple assignments simultaneously and has strong organizational skills.
    • Employs effective time management skills and meets deadlines.
    • Demonstrates a strong attention to detail.
    • Demonstrates initiative and resourcefulness as a self-starter.
    • Demonstrates proficiency with Microsoft Office (Excel, Outlook, PowerPoint, Word).

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