Regulatory Affairs Director, Global Distributor Management

6 days ago

Uxbridge, United Kingdom Gilead Sciences International, Ltd. Full time

Job Summary:

This is an exciting opportunity for an Associate Director, Regulatory Affairs to join the Gilead Global Regulatory Affiliates & Distributor team to provide oversight and management of regulatory activities provided by Gilead's in-market partners in the Gilead Patient Solutions (GPS) region (South Asia, South-East and Central Asia and Africa).

Key Responsibilities:

  • Management of regulatory capability for Gilead's in-market partners:
  • Due diligence
  • Distributor on-/off-boarding
  • Periodic regulatory training of the in-market partners – process and expectation setting.
  • Maintain oversight of legal agreements with in-market partners and understand the content of all agreements and how they impact regulatory activities.
  • Develop, propose, and agree regional and national regulatory strategies based on registration requirements, product knowledge and company strategy.
  • Maintain oversight and provide regulatory insight to optimise the regulatory strategy in relation to the product lifecycle.
  • Partner with the business to understand and support the commercial and access needs, align on priorities and regulatory filing strategy.
  • Proactively identify and support the resolution of emerging regulatory issues that may impact product supply.
  • Provide regulatory input to support product launch activities.
  • Assess and interpret regulatory intelligence and local knowledge to drive strategic recommendations.
  • Comment on draft regulatory guidance/legislation wherever possible in collaboration with key stakeholders.
  • Contribute to regional cross-functional meetings and represent Gilead Regulatory in external meetings as required.
  • Actively participate in Trade Associations as required.
  • Liaise with Gilead's commercial manufacturing organization to plan and execute the introduction of product packaging for assigned territories in compliance with regulatory requirements.
  • Support Gilead in-market partner audits and Regulatory Authority inspections as required.

Requirements:

  • Experience in regulatory affairs across international markets, including regulatory submission experience and a good understanding of the drug development process from development through to post-marketing.
  • In-depth knowledge of regulatory requirements, including ICH requirements and regional requirements.
  • Knowledge of current global and regional trends in biopharmaceutical regulatory affairs with proven effectiveness applying this knowledge.
  • Experience working with and/or oversight of distributor markets/external vendors is advantageous.
  • Ability to lead cross-functional teams, and develop, communicate and implement regulatory strategy.
  • Excellent verbal and written English communication skills, and demonstration of excellent interpersonal and multicultural skills.
  • Excellent planning and organisational skills with the ability to work simultaneously on multiple projects with tight timelines.
  • Demonstrated effectiveness in collaboration and teamwork, with analytical and assessment skills.
  • Bachelor's degree in Health or Pharmaceutical Sciences.
  • Significant experience in Regulatory Affairs including Pharma/Biotech industry and/or partnering with and/or responsible for oversight of in-market partners.
  • Experience in interacting with Regulatory Agencies.
  • Strong background in dossier preparation and regulatory submissions.
  • Ability to read, write and speak English at an advanced level.
  • Strong relationship building skills; demonstrated leadership coupled with the ability to work well with people at all levels and across all functions of the organization.
  • Advanced analytical skills.
  • Attention to detail and proven ability to manage multiple tasks and priorities in a matrix team environment.
  • Excellent communication, technical and presentation skills.
  • Computer skills (Advanced Microsoft Excel, Word, Outlook, and PowerPoint).
  • Expertise in quality systems is advantageous.

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