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Gilead

Director, Regulatory Affairs: Southern Cone and Andean Region (Latin America)

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Description Summary

Reporting to the Executive Director of Regulatory Affairs, the Director of Regulatory Affairs (Southern Cone and Andean Region) is responsible for providing strategic leadership and direction for regulatory activities across Gilead’s therapeutic areas in Argentina, Chile, Uruguay, Colombia, Peru, Bolivia, Ecuador, Paraguay and Venezuela.  This role requires a cross-functional partnership, to ensure that all projects have the appropriate local regulatory input and guidance. 

The ideal candidate has expertise in local regulatory affairs and quality systems.  Moreover, they have had extensive exposure across much of the Pharmaceutical or Biotechnology sector, partnering with and/or responsible for oversight of distributors.

Role and Responsibilities:

·        Develop, propose and agree local registration strategies based on regulatory requirements, product knowledge and company strategy.

·        Primary contact with national authorities and / or distributor partners for regulatory issues regarding the company’s products (clinical trial applications, new marketing authorization applications and lifecycle maintenance).

·        Design and seek alignment on innovative regulatory pathways for product development.

·        Proactive in identifying emerging issues that may impact product development.

·        Submission and follow-up of all regulatory applications  to national authority.

·        Obtain and maintain necessary regulatory-associated licenses and obligations with national agencies required for the company to conduct its business.

·        Support and lead (where appropriate) regulatory affairs contribution to product launch activities.

·        Obtain, provide and interpret national regulatory intelligence and propose strategic recommendations.

·        Comment on draft regulatory guidance/legislation wherever possible in collaboration with key stakeholders.

·        Represent the Regulatory Function at internal and external meetings. Work proactively to build contacts with local Regulatory Authorities and continue to build upon existing network of regulatory contacts.

·        Active participation with industry working groups as required.

·        Review and approval of artworks in line with approved licenses and Gilead’s internal processes.

·        Liaison with Gilead Sciences Commercial manufacturing regarding introduction of packaging for assigned territory.

Pharmacovigilance

·        Ensure that where Pharmacovigilance responsibilities are assigned to Regulatory Affairs, that these are allocated, supported and delivered appropriately, and as required.

Regulatory Compliance

·        Audit and inspection management  support  for and follow up of self-inspections, internal inspections and inspections by external relations, i.e Ministry of Health and other bodies by interfacing with key functions (Regulatory Compliance, Quality Assurance)

·        Preparation and maintenance of required and relevant local SOPs and associated process documents required internally and externally.

·        Training Curricula periodic review and updates.

·        Coordination of record retention as required for regulatory affairs.

·        Support GDP practices, as required from Regulatory Affairs.

Commercial Compliance

·        Contribute to and support the review and approval of promotional materials in accordance to the company’s internal promotion guidelines, national legislation and Code of Practice.

·        Provision of guidance and assistance to commercial function during preparation of promotional materials.

Specific Education & Experience Requirements:

·        Bachelor’s Degree in Pharmacy.  Must be registered as a Pharmacist in Argentina.   

·        A minimum of 12 years’ experience in Regulatory Affairs in the pharmaceutical industry. - Previous experience in responsibilities already described. - Long standing experience in directly interacting with Regulatory Agencies and Distributor Partners. - Strong background with dossier submissions.

·        Ability to read, write and speak English and Spanish at the 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.

·        Exceptional 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 with Microsoft Excel, Word, Outlook and PowerPoint).

·        Experience in the registration of Biological or Biotech-based products is advantageous.


For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

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