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Palo Alto

    Cco - Palo Alto, CA, United States - Ascendis Pharma

    Ascendis Pharma
    Ascendis Pharma Palo Alto, CA, United States

    3 weeks ago

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    Description

    The Director, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies encompassing clinical, non-clinical and CMC disciplines.

    Provides expertise in translating regulatory requirements into practical, workable plans for project teams with international participants. May mentor and potentially supervise other regulatory professionals working on the project team and regulatory process-related topics. Responsible for strategic and operational regulatory input for cross functional (CMC, non-clinical and clinical) areas in collaboration with other project team members and regulatory colleagues

    • Contributes to the development of global clinical regulatory plans and strategies; identifies and proposes risk mitigation strategies; influences global project teams and sub-teams
    • Provides regulatory information and guidance for product development and planning throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure compliance and potential product expansion
    • Acts as the company representative with regulatory authorities
    • Prepares and/or manages submissions that are technically complex and able to have extensive/in-depth interactions with departments outside of regulatory affairs; Excellent organizational skills (verbal and written) with ability to work on and/or oversee a number of projects with tight timelines
    • Maintains up-to-date knowledge of highly complex regulatory requirements and communicates changes in regulatory information to project teams
    • Work is performed under direction of a Senior Regulatory Affairs professional
    Contribute to internal regulatory policies and procedures to achieve best practices and work processes
    BS/BA Degree in a Scientific Discipline, Advanced Degree required.

    • Minimum of 10 years overall regulatory experience (at least 6 years in Oncology), and preferably including experience managing investigational and marketed products
    • Prior experience representing Regulatory Affairs on cross-functional teams is desirable.
    • Experience working on international teams desirable
    • Must have an extensive knowledge of regulatory requirements, including ICH and regional requirements, and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business
    • Must be capable of critically reviewing complex technical documents and influencing colleagues across functions
    • Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; Ability to travel up to 10-20% of the time domestically and internationally
    Talent Acquisition Partner or Human Resources Director) is not allowed. Medical insurance
    ~ Dental insurance
    ~Disability insurance
    ~
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