• Head of Regulatory Affairs

    Job Locations US-MA-Bedford
    Posted Date 3 weeks ago(4/2/2018 11:03 AM)
    Job ID
    2018-1064
    # of Openings
    1
    Category
    Regulatory
  • Overview

    Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. Product pipeline candidates utilize the hydrogel technology to provide differentiated drug delivery solutions by creating sustained release dosage forms that can be tailored to produce the desired drug release profile. Our product portfolio is intended to overcome the issues of patient compliance and adherence by providing a means of more consistent and reliable drug dosing.  We have an approved medical device, and the remainder of the pipeline is regulated as pharmaceutical products.

    This position will lead the Regulatory Affairs function for Ocular Therapeutix.  The incumbent will provide strategic and operational leadership related to regulatory considerations for product development and commercialization, with a strong focus on health authority interactions.  Since the Company formulates and manufactures its products, there is a significant emphasis on regulatory CMC leadership and contributions. 

    Responsibilities

    •Recruit and mentor regulatory liaison, regulatory operations and regulatory CMC personnel
    •Establish regulatory strategy for development and commercialized products through collaboration with senior leaders across the company
    •Provide regulatory advice and proactively identify and communicate issues across the company
    •Plan and oversee development of compliant regulatory documents and dossiers for health authority submissions
    •Oversee effective tracking of regulatory submissions and commitments
    •Review and approve product labelling, including drug promotion/advertising materials
    •Work effectively with consultants and partner companies to achieve company goals
    •Oversee the preparation of regulatory policies and procedures
    •Ensure appropriate internal and external training programs for regulatory staff
    •Preparation and oversight of department operating plans and budgets
    •Remain current with the global regulatory environment and communicate impact of changes on business and product development programs

    Qualifications

    •Bachelor’s degree in biopharma or related field.  Advanced degree in related area preferred
    •Minimum of 15 years of experience in pharmaceutical/biotech industry with increasing responsibilities, including leadership role in a regulatory organization
    •Preparing and gaining approval for IND, NDA and MAA submissions; medical device submission experience is a plus
    •Preparation of development and post-approval regulatory strategy and tactics
    •Thorough knowledge of U.S. and ex-U.S. regulations and procedures
    •Direct interaction with U.S. and international regulatory authorities
    •Strong management and interpersonal/communication skills
    •Prior success in working effectively with senior scientific, medical, commercial and operations staff
    •Ability to blend analytical and critical-thinking skills to enable data-driven, strategically oriented preparation of regulatory documents
    •Demonstrated leadership, negotiation and collaboration abilities
    •Outstanding verbal and written communication skills
    •Excellent organizational skills and attention to detail
    •Ability to travel approximately 10-15% (domestic and some international) for meetings and educational seminars

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