Director, Global Regulatory Affairs Liaison - Virology

Director, Global Regulatory Affairs Liaison - Virology

Gilead

Uxbridge or Cambridge, United Kingdom

POSITION OVERVIEW:

You will act as the Global Regulatory Lead on more complex or multiple products, compounds, indications or projects in the established products therapeutic area. You will typically be assigned a portfolio of products or projects or key Gilead assets to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects. 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 labeling and packaging for assigned products or projects; guiding and advising other colleagues in the thorough and compliant completion of these activities as required. You will play a leadership role in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities. You will also help develop the TA's Regulatory leadership pipeline through coaching and mentoring other Regulatory colleagues.

EXAMPLE RESPONSIBILITIES:

  • Accountable for the successful oversight and completion of a broad spectrum of regulatory activities and deliverables for typically a portfolio of products, compounds, indications and/or other projects in the assigned therapeutic area;
  • 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 as required;
  • 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 team 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;
  • As needed, works with outsourcing vendors to ensure outsourced work is completed to a high standard.

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.

Education & Experience

  • BA/BS or advanced degree in life sciences or related field with extensive experience in the biopharma industry, including extensive experience working in regulatory or a related discipline. Significant experience setting the regulatory strategy and leading a broad range of regulatory activities for biopharmaceutical products;
  • Extensive regulatory, quality, compliance or related experience in the biopharma industry;
  • Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products in the postmarketing phase of the lifecycle;
  • Experience and proven effectiveness working and negotiating with regulatory authorities;
  • Significant experience participating in cross-functional projects and teams with responsibilities related to post marketing activities;
  • Proven track record of successfully managing large scale, complex, time-sensitive projects.

Knowledge & Other Requirements

  • Expert knowledge of the drug development process, global and EU regional regulatory requirements for approved medicinal products;
  • Expert knowledge of all key functions involved in the post-marketing phase of development;
  • 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;
  • 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. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees;
  • Strong negotiation and conflict resolution skills;
  • Strong coaching capabilities to mentor/develop staff in a matrixed environment;
  • Experience working with vendors is a plus;
  • When needed, ability to travel.

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