Associate Director Regulatory

3 days ago

Melbourne, Victoria, Australia Gilead Sciences, Inc. Full time

Gilead Sciences, Inc. seeks a highly skilled Associate Director Regulatory to join its team in the ANZ affiliate.

The ideal candidate will be responsible for leading projects for the Regulatory Affairs team, ensuring compliance with country-specific legislations and regulations linked to MA/local license as MA Holder or local legal representative. This role will work closely with cross-functional colleagues, including Business Unit team members, Regulatory Affairs, Medical Affairs, Government Affairs, Public Affairs, Commercial & Trade Operations, Finance, and out-of-country Global Value & Access teams.

About the Role:

  • Contributes to the Vision and Direction for the RA organization at the country level in line with global/Regional RA and local Affiliate Vision, setting clear goals and objectives aligned with global Development Organization strategy.
  • Ensures Gilead fulfills all relevant requirements linked to MA/local license as MA Holder or local legal representative for the Affiliate.
  • Contributes to resource and budget planning and utilization.
  • Leads or provides input to the preparation of challenging regulatory submissions (initial MA Applications, line extensions, scientific advice, inspections, quality assurance related issues, risk management/minimization activities) to local HA and leads or provides input to interaction, negotiations, and communication internally and externally, co-ordinates cross-functional responses, and acts as the main point of contact for local HA.
  • Leads or supports country/national scientific advice and/or pre-submission meeting preparation and follow-up.
  • Leads or provides Affiliate input to International and global regulatory strategy upon request, including input into clinical development programs.
  • Ensures compliance with local law and regulation and consistency with global procedural documents, including Quality Assurance matters such as acting as a subject matter expert or audit/inspection lead within the Affiliate, ensuring essential licenses, contracts, and agreements are in place, and falsified/counterfeit products, stockouts, and recalls are managed optimally.
  • Initiates local improvements and contributes to local and/or global process improvements which have a significant impact on RA and other departments, assesses proposed changes to local procedural documents, sharing of best practice, and impact on existing processes.
  • Responsible for promotional material review and approval, certifying materials where appropriate.
  • MAY act as the local Gilead representative as required by local law or supervises these individuals e.g., Qualified Person QA, QPPV, Responsible Person PV, RP QA etc.
  • Leads or provides Affiliate input to risk assessments on major local regulatory issues and changes, developing mitigation strategies as required.
  • A regulatory expert in updating and preparing the Company for major changes in regulatory legislation and competitor information in the country, contributes to guideline and regulation development, and develops strategies to optimize the outcome.
  • Leads or provides Affiliate input as an ambassador for RA and Development Organization at internal and external meetings or working parties, building recognition as a thought leader.
  • Mentoring, training, and coaching regulatory and non-regulatory staff as required.

Key Requirements:

  • Leadership skills showing ability to influence externally, cross-functionally, and within global RA.
  • Vision and direction setting.
  • Extensive experience working with local HA at a senior level.
  • Capable of developing and implementing regulatory strategies and/or managing complex discussions with local HA.
  • Experienced leader of projects and teams.
  • Good people management and development experience.
  • Strong cross-functional internal and external network.
  • Experienced influencer, negotiator, and decision maker.
  • Good decision-making and prioritization skills are important.
  • Excellent verbal and written English language skills, organization skills, and interpersonal communication skills required.

What you will bring to the role:

  • 12+ years of experience in RA or other relevant industry experience with BS/BA or 10+ years of experience in RA or other relevant industry experience with advanced degree. Degree in a scientific field is preferred.
  • Excellent knowledge and proven experience in understanding and implementing regulatory requirements in Pharmaceutical/Biotech Industry, including ICH requirements and regional requirements, and an understanding of current trends in the local Affiliate.
  • Experienced in developing and implementing complex regulatory strategy and managing challenging negotiations with HA.
  • Strong knowledge of quality assurance, promotional, and non-promotional review as well as pharmacovigilance and market access.
  • Very experienced in working and leading cross-functional project teams.
  • Excellent working knowledge regarding country/national and regional HAs and the local Trade Association, recognized as a thought leader by both organizations.
  • Excellent knowledge of developing trends in the local rules and regulations and the potential impact to the organization.

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