Associate Director, Regulatory Affairs, Oncology

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Description


 

POSITION OVERVIEW:

You will act as the Regional Regulatory Lead on more complex or multiple products, compounds, indications or projects in the assigned therapeutic (TA) area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. You may act as the Global Regulatory Lead for early-stage or other programs. You will lead Regulatory Submissions Teams or other Regulatory Project Teams and represent Global TA Regulatory on cross-functional core and sub-teams. You will typically serve as a Gilead contact to / for regulatory authorities. You will oversee preparation and maintenance of regulatory submissions, regulatory labelling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities. You will also play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities.

RESPONSIBILITIES:

  • As needed, represents Gilead in negotiations with regulatory authorities.
  • Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.
  • Represents Regulatory Affairs and may serve as Regional Lead or Global Regulatory Lead on cross-functional/cross-regional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
  • May participate on other Sub-teams (e.g., Study Management, Clinical, Nonclinical, Biomarkers) or assign such to other colleagues and oversee and guide their sub-team participation.
  • Defines the regulatory strategy for multiple Gilead products or projects.
  • Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.
  • Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial or investigational product(s). Examples include meeting requests, briefing packages, original Investigational New Drug (IND), IND amendment, and routine submissions (e.g., Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.).
  • Oversees and approves the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc.
  • Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.
  • Critically reviews documents for submission to regulatory authorities.
  • Provides matrix management and leadership to project teams.
  • Provides accurate and thorough input and recommendations into resource plans required to complete own deliverables. Tracks resources to ensure compliance with agreed resource allocation, including budgets.
  • Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

    • REQUIREMENTS:

    We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

    Rest of World Education & Experience

    BA/BSC or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience leading a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.

    Knowledge & Other Requirements

  • In-depth understanding of U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards for medicinal products. Understands varying regional or country regulatory requirements for assigned markets.
  • In-depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs. Proven effectiveness applying this knowledge to optimize team deliverables and results.
  • Demonstrates advanced regulatory and business knowledge and advanced analytical abilities, as evidenced by strengths in assessing complex, multidisciplinary data, understanding and effectively advising on its regulatory implications.
  • In-depth knowledge of relevant health authorities (HAs), including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
  • Able to represent Gilead to regulatory authorities when managing standard and non-standard negotiations.
  • Thorough knowledge of the drug development process, including all key functions involved in the various stages of drug development from early research through post-marketing.
  • Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.
  • Strong interpersonal skills and understanding of team dynamics.
  • Strong communication and organizational skills.
  • Strong negotiation and conflict resolution skills.
  • When needed, ability to travel.

    • Equal Employment Opportunity (EEO)

    It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.


    For Current Gilead Employees and Contractors:

    Please apply via the Internal Career Opportunities portal in Workday.

    Apply
    Location:
    Uxbridge
    Job Type:
    FullTime

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