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    Manager, Medical - Palo Alto, CA, United States - Ascendis Pharma A/S

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    Description
    Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.
    Today, we're advancing programs in Endocrinology Rare Disease, Oncology, and Ophthalmology.

    We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company focused on making a meaningful difference in patients' lives.

    Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

    Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark.

    The Manager, Regulatory Affairs will be responsible for supporting and developing global regulatory strategies for both development and commercial products encompassing clinical, non-clinical and CMC disciplines.

    Provides support in translating regulatory requirements into practical, workable plans for project teams with international participants. May mentor other regulatory professionals working on the project team and regulatory process-related topics. The position will be based in Palo Alto, CA and reports directly to the Senior Director, Regulatory Affairs.

    Responsible for strategic and operational regulatory input and support for cross functional (CMC, non-clinical and clinical) collaboration with other project team members.


    Contributes to the development of global clinical and regulatory plans and strategies, identifies, and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.

    Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions and approvals associated with assigned projects

    Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs and external to the company.

    Maintains knowledge of highly complex regulatory requirements up to current date and communicates changes in regulatory information to project teams.

    Work is performed under direction of a Senior Regulatory Affairs professional.

    BS/BA Degree in a Scientific Discipline, Advanced degree desirable.
    Minimum of 4 years of direct regulatory affairs experience in the biopharmaceutical industry.
    Experience working on international teams desirable.

    Demonstrate solid 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.

    Review technical documents and influencing colleagues across functions.

    Must have experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; Ability to travel up to 10% 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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