Jobs
>
Palo Alto

    Associate Director, Regulatory Affairs - Palo Alto, CA, United States - Ascendis Pharma

    Ascendis Pharma
    Ascendis Pharma Palo Alto, CA, United States

    4 weeks ago

    Default job background
    Description
    The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required. The RA Associate Director, Labeling will be overall responsible for ensuring compliance with US regulatory requirements for labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to meet agreed timelines and works both independently and in a team environment. Global coordination is also required and work with external partners may be required. Key responsibilities:

    •Drive process for development and management of US & Americas labelling content for initial and updated labels, including working with the Global Regulatory Lead for developing key messaging and strategy

    •Provide labeling advice and expertise on Company Core Data Sheet (CCDS), USPI and Canadian Monograph content, and collaborate with other market leads to develop local labeling in line with global strategies and local regulations

    •Coordinate US labeling activities for regulatory submissions, product maintenance and safety variations, including developing timelines, involving relevant SMEs, and handling reviews

    •Understand and interpret regulatory requirements for labelling to meet applicable regulations

    •Perform global label competitive intelligence, and make recommendations for actions

    •Plan, support and advise in liaison and negotiation with FDA and other agencies as needed for labelling content

    •Ensure and maintain tracking and archiving of approved labels

    •Develop project timelines and manage labeling projects from initiation to completion

    •Contribute to development of key labeling processes and infrastructure

    •Work closely with global labeling managers to ensure consistency and alignment Requirements

    •BS/BA or equivalent degree in a Scientific Discipline, advanced degree desirable

    •Regulatory experience of at least 8 years, and at least 3 years direct experience with labeling in the US

    •Solid knowledge of regulatory labelling requirements in the US, have an understanding of current global and regional trends and ability to assess the impact of these requirements

    •Experience working in international teams

    •Excellent collaboration and communication skills

    •Preference for creative thinking and solution development

    •Ability to interact cross-functionally with members of commercial, legal, safety, medical, and others

    •Proficient in document editing including Microsoft office applications (Word, PowerPoint, Excel)

    •Experience in systems (e.g. document management systems, labeling systems, etc.

    •Recognize when to provide labeling guidance to product strategy teams, product review teams, HA response teams, labeling stakeholders, junior team members, or others as needed

    •Strong understanding of the purpose of the Target Product Label and CCDS and the associated implications on labeling globally, downstream processes, and compliance needs

    •Participates with influence in or leads departmental and cross-functional taskforces and initiatives

    •Interpret labeling regulations and guidance

    •Responds to challenging situations in a calm and confident manner

    •Embraces change and quickly alters course in response to new challenges

    •Ability to travel up to 10% of the time domestically and internationally Estimated compensation: $180-200K/year A note to recruiters: We do not allow external search party solicitation. Presentation of candidates without written permission from the Ascendis Pharma Inc Human Resources team (specifically from: Talent Acquisition Partner or Human Resources Director) is not allowed. If this occurs your ownership of these candidates will not be acknowledged. Benefits
    • Medical insurance
    • Vision insurance
    • Dental insurance
    • 401(k)
    • Paid maternity leave
    • Paid paternity leave
    • Commuter benefits
    • Disability insurance
    #J-18808-Ljbffr
  • Ascendis Pharma

    Head of Regulatory Affairs, Oncology

    3 weeks ago

    Ascendis Pharma Palo Alto, United States

    HybridPalo Alto, California, United StatesOncology, Regulatory, OncologyFull time1404 · Description · We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncol ...

  • Infosoft

    Regulatory Affairs Specialist-4694

    2 weeks ago

    Infosoft Palo Alto, United States

    One of our clients is looking for a talented and highly motivated **Sr. Regulatory Affairs Specialist**. Please **send your resume** if you would like to pursue this opportunity and you authorize Infosoft to represent you for this position. · Here are the job position details for ...

  • Infosoft Teksolutions

    Regulatory Affairs Specialist(W2 Only)

    2 weeks ago

    Infosoft Teksolutions Palo Alto, United States

    Here are the job position details for your review: · Job Title**:Regulatory Affairs Specialist (W2 Only)** · Pay Rate**:$63 to $68.89/HR** · Duration**:12 months** · Location**:Palo Alto, CA (Hybrid - 2 days/week onsite)** · **Must have skills on the Resume**: · - **Product Regis ...

  • Net2Source Inc.

    Regulatory Affairs Specialist

    2 weeks ago

    Net2Source Inc. Palo Alto, United States

    Job Title: Regulatory Affairs Professional 4 · Duration: 12 months (Possible Extension ) · Location: Palo Alto CA Hybrid) · Experience: 5-8 years. · Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in ...

  • Cygnus Professionals

    Regulatory Affairs Professional

    2 weeks ago

    Cygnus Professionals Palo Alto, United States

    Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various contexts. Solid professional judgment and problem solving competence. Improves existing processes and approaches · Product Registration Exper ...

  • Net2Source Inc.

    Regulatory Affairs Specialist

    2 weeks ago

    Net2Source Inc. Palo Alto, United States

    Job Title: Regulatory Affairs Professional 4 · Duration: 12 months (Possible Extension) · Pay Rate: $68.89/hr. · Location: Palo Alto CA USA 94304 Hybrid · Need Local Candidates to Palo Alto CA · Job role required to support tasks for software and VBT projects. · Position Descri ...

  • Net2source Inc.

    Regulatory Affairs Specialist

    14 hours ago

    Net2source Inc. Palo Alto, United States

    Job Title: Regulatory Affairs Professional 4Duration: 12 months (Possible Extension )Location: Palo Alto CA Hybrid)Experience: 5-8 years.Knowledge: Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how to / in various cont ...

  • Net2source

    Regulatory Affairs Specialist

    1 week ago

    Net2source Palo Alto, United States

    Job Title: Regulatory Affairs Professional 4 · Duration: 12 months (Possible Extension ) · Location: Palo Alto CA Hybrid) · Experience: · 5-8 years. · Knowledge: · Deep professional know-how and experience in one Sub Job Family. Masters domain. Transfers and applies know-how ...

  • Net2source

    Regulatory Affairs Specialist

    1 week ago

    Net2source Palo Alto, United States

    Job Title: Regulatory Affairs Professional 4 · Duration: 12 months (Possible Extension) · Pay Rate: $68.89/hr. · Location: Palo Alto CA USA 94304 Hybrid · Need Local Candidates to Palo Alto CA · You could be just the right applicant for this job Read all associated informat ...

  • Cytokinetics

    Regulatory Affairs Associate

    5 days ago

    Cytokinetics South San Francisco, United States

    Reporting to the Senior Director of Regulatory Affairs, the Regulatory Affairs Associate is responsible for coordination and preparation of a variety of regulatory submissions and for assisting the Regulatory Affairs team with various projects. · **Responsibilities** · - Prepare ...

  • Sterling Kohler

    Scientific & Regulatory Affairs

    4 weeks ago

    Sterling Kohler Palo Alto, CA, United States

    Location: Hybrid, 2-3 days/week onsite in New York City, NY or Palo Alto, CA · Kohler Ventures is an independent company wholly owned by Kohler Co., global leader in the manufacture of kitchen and bath products, tile and home interiors, and an international host to award-winning ...

  • University of California San Francisco

    Regulatory Affairs Analyst

    6 days ago

    University of California San Francisco San Francisco, United States

    The analyst works independently, under the direction of the Regulatory Affairs Manager, to review cooperative and industry-sponsored protocols, revise local informed consents (ICFs), and submit review packets (protocols, ICFs, and other required documents) to the UCSF IRB and ext ...

  • AbbVie

    Regulatory Affairs Manager

    1 week ago

    AbbVie South San Francisco, United States

    **Company Description** · **Job Description** Key Responsibilities** · - Responsible for providing regulatory strategy & support for global development. · - Responsible for supporting teams & efforts around major filing activities & Regulatory Health Authority (RHA) interactions ...

  • Cytokinetics

    Associate Director, Regulatory Affairs

    3 weeks ago

    Cytokinetics South San Francisco, United States

    Reporting to the Senior Director, Regulatory Affairs, the Associate Director of Regulatory Affairs leads regulatory support for assigned programs to ensure sound regulatory planning and tactical implementation of US and international development strategies. · **Responsibilities** ...

  • Hyperfine Inc

    Sr. Regulatory Affairs Specialist

    3 weeks ago

    Hyperfine Inc Palo Alto, United States

    Company Profile · Hyperfine (NASDAQ: HYPR) is the groundbreaking MedTech company that created Swoop, the world's first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. Our mission is to transform patient care by ...

  • Ascendis Pharma

    Director, Regulatory Affairs, Oncology

    5 days ago

    Ascendis Pharma Palo Alto, California, United States Permanent

    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 wi ...

  • Proclinical Staffing

    Senior Manager Regulatory Affairs

    3 weeks ago

    Proclinical Staffing Palo Alto, United States Permanent

    Senior Manager Regulatory Affairs - Remote - Permanent · Proclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position. This role is integral to the ongoing development, registration, and life-cycle management of our product candida ...

  • Proclinical Staffing

    Senior Manager Regulatory Affairs

    2 weeks ago

    Proclinical Staffing Palo Alto, United States

    Senior Manager Regulatory Affairs - Remote - Permanent · Proclinical is actively seeking a Senior Manager for Regulatory Affairs. This is a remote permanent position. This role is integral to the ongoing development, registration, and life-cycle management of our product candida ...

  • Hyperfine

    Sr. Regulatory Affairs Specialist

    3 weeks ago

    Hyperfine Palo Alto, United States

    Company Profile · Hyperfine (NASDAQ: HYPR) is the groundbreaking MedTech company that created Swoop, the world's first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. Our mission is to transform patient care by ...

  • Ascendis Pharma

    Director, Regulatory Affairs, Oncology

    3 weeks ago

    Ascendis Pharma Palo Alto, CA, United States

    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 wi ...