Associate Director, Regulatory Submission Management

We need to output HTML fragment with sections: About the role? The posting includes intro about Gilead, mission, etc. That could be "About the role" or maybe "About Gilead". The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We need to include sections only when posting has real specific content. We have content: job description (responsibilities), basic qualifications, preferred qualifications, people leader accountabilities, salary range (Pay), benefits. Also location: Foster City CA, no relocation. Could be part of "About the role" or maybe a short paragraph. We must not repeat job title as heading. No Job ID. Remove boilerplate: cookie/navigation/legal/EEO etc. At end there is EEO statement; we should drop that. We need to preserve all substantive information. So we need to include the mission description maybe as "About the role" or "About Gilead". Probably "About the role" includes the description of role and mission. We need to use

• for any list of duties/requirements/benefits. So duties list: essential duties and job functions (many bullet-like sentences). We'll convert each sentence into
• . Similarly for qualifications: basic qualifications and preferred qualifications maybe as lists. Benefits: mention company-sponsored medical, dental, vision, life insurance plans, discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, benefits package. Also link to benefits info. We'll list. Pay: Salary range given. Schedule: Not mentioned; we should not create Schedule section. People Leader Accountabilities: maybe under "Responsibilities" or separate "People Leader Accountabilities". Could be a section "People Leader Accountabilities". The instruction list includes those example headings but not limited; we can add if content exists. It does. We need to avoid filler like "commensurate with experience". Not present. We must output only HTML fragment, no /, no markdown. Let's craft:

  About the role

  At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

  Then maybe a short paragraph about location: Based out of Foster City CA, no relocation. We could include that in About the role or separate "Location". But location not in list of headings; we could just embed in About the role. Next: Responsibilities (Essential Duties And Job Functions). We'll list each duty as
• . We need to capture all duties sentences. Let's extract them: - Directs planning and execution of regulatory programs and submission activities for highly complex global submissions and/or initiatives. - Partner with RA Liaisons and GRAD to generate a global filing plan highlighting and overlaying each region’s Regulatory submission pathways through approval. This includes the preparation and maintenance of program level timelines with regulatory milestones. - May lead the Regulatory Portfolio Planning for programs or submissions on an as needed basis. - Directs moderately complex project/initiative communications and ensures that all stakeholders are fully informed and knowledgeable of project activities and their status. - Plans and conducts regulatory submission team meetings. Anticipates obstacles and develop solutions within the team. - Fosters effective and productive communication among various Regulatory Affairs groups including RA Liaisons, GRAD, Labeling, Advertising and Promotion, Innovation, Digital & External Partnerships (IDEP), Medical Writing, and representatives from other functional areas, such as Regulatory CMC, as appropriate, via proactive networking and facilitation of the Regulatory Project Team. - Provides Regulatory Submission Management support for programs, projects, or initiatives; attends sub-team meetings; organizes ad hoc working groups as needed. - May develop and implement continuous improvement, innovation and optimization initiatives across the department. - Manages 2 – 4 major regulatory submissions including but not limited to NDAs, MAAs, BLAs, sNDAs/T2Vs, INDs, RtQs, submissions across projects/programs (platform). - May partner with RA Liaisons and/or GRAD to support the portfolio planning for a specific program, lead a sub-capability within RSM or lead submission execution for a specific region within the RSM organization. - In relation to regulatory submissions, coordinates, tracks and prepares project information and activities, including minutes, timelines, action items and function-specific deliverables. Ensures integration of project timing, scope and resources. Ensures timely, efficient and effective meetings and progress on activities between meetings. - Will initiate or contribute to local and global process improvements across therapeutic areas which have a significant impact on the business and work collaboratively with other functional areas and Regulatory Affairs’ functions at other global sites. - Organizes and/or leads preparation of high-quality documents for review by internal committees and external stakeholders. May author documents and/or procedures for leadership teams. - Acts as a subject area expert for specific project, processes and/or regions. - Ensures that work complies with established practices, policies and processes and technical specifications in accordance with global health authority requirements. Works with RA Liaison and/or GRAD to ensure that submissions are prepared in line with ICH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures. We'll put each as
• . Next: Basic Qualifications and Preferred Qualifications. Could combine into "Qualifications" section with two sublists? But instruction: use
  • for any list of duties/requirements/benefits. So we can have a

    Qualifications

    and then two
    maybe with headings inside? Could also separate Basic Qualifications and Preferred Qualifications as separate sections. The instruction list includes Qualifications as a possible heading. We'll do that. We'll put Basic Qualifications as
    • ...
    . Preferred Qualifications as another
    . Basic Qualifications text: "10+ Years with BS/BA OR 8+ Years with MS/MA or MBA". That's it. Preferred Qualifications: a long paragraph with many bullet-like items separated by semicolons. We need to split into list items. Let's parse: - BA/ BS with 10+ relevant submission management, regulatory project management or regulatory operations experience in the biopharma industry; or 8+ years’ relevant experience with MA/MS/MBA; or 5+ years’ relevant experience with PharmD/PhD - Proven effectiveness managing submission teams in life sciences, including effectiveness in preparing compelling documentation for senior leadership, determining the appropriate scope of projects, helping teams develop creative alternative scenarios, and acting effectively as a thought partner to others. - Proven track record of successfully managing multiple submissions simultaneously - Knowledgeable in drugs and biologics development and regulatory requirements - Mentorship or experience leading others in a matrixed environment strongly preferred. - PMP (Project Management Professional) or other PM certification or equivalent is a plus. - Recognized as a functional area expert for specific systems, products, programs, projects and/or initiatives. - Knowledge of regulatory submission requirements specific to key regions such as the US and EU and general awareness of global health authority requirements and the impact on building efficient global reuse strategies. - Awareness of current global and regional trends. - Strong negotiation and conflict resolution skills. - Digital, strategic and enterprise mindset. - Complete knowledge of full cycle submission management and has shown ability to effectively apply this knowledge to achieve targeted submission outcomes. - Advanced knowledge of submission management best practices and tools and has shown ability to apply these to improve submission efficiencies and effectiveness. - Significant industry knowledge, including knowledge of drug development, technical knowledge and is able to flex own knowledge to work on digital and scientific projects. - Able to advise cross-functional partners on technical health authority requirements and RSM processes to meet business goals and objectives. - Advanced knowledge of functional regional, or therapeutic area, as evidenced by independence in designing, implementing and managing submission plans and deliverables and resource management - Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives. - Knowledge of Agile Methodologies and their application in the R&D biopharma environment a plus. - Ability to understand and communicate technical, scientific and/or business elements in a clear and concise manner. Strong interpersonal skills and understanding of team dynamics. - Proven ability to work successfully in a team-oriented, highly matrixed environment. - Ability to take accountability and empower individuals and teams to make effective decisions which are aligned with the company’s vision, values and goals. - Must be quality driven individual with strong attention to detail and accuracy. - Where applicable, oversees the work of external contractors supporting deliverables and other activities. - Coaches, trains, and provides guidance to less experienced Submission Management colleagues. - Advanced knowledge and skill with reporting and tracking tools. Veeva, Docubridge, Smartsheet, Planisware, Microsoft Project a plus. - When needed, ability to travel. We'll make each bullet a
    • . Next: People Leader Accountabilities. We'll make a section

      People Leader Accountabilities

      with
      • items: - Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. - Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. - Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. Next: Pay. Section

        Pay

        with

        The Salary Range For This Position Is Bay Area: $182,070.00 - $235,620.00. Other US Locations: $165,495.00 - $214,170.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.

        But benefits also separate section. Benefits:

        Benefits

        with
        • company-sponsored medical, dental, vision, and life insurance plans
        • discretionary annual bonus
        • discretionary stock-based long-term incentives
        • paid time off
        • benefits package (general)
        maybe also link but we can't include external link? It's okay to include as but not required. We'll keep as text. We should not include the link to benefits page? It's substantive but maybe we can include as

        For additional benefits information, visit Gilead Benefits

        . That's okay. We must not include boilerplate like EEO etc. Already omitted. Now ensure we don't repeat job title. Not used. Now produce