Head of (Director) Regulatory Affairs (m/f/d) South Africa - Gilead Sciences

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Job Description

Head of (Director) Regulatory Affairs (m/f/d) South Africa

Location: Johannesburg

Description Summary

Reporting to the Senior Director of Regulatory Affairs, the Head of (Director) Regulatory Affairs (m/f/d) South Africa is responsible for providing strategic leadership and direction for regulatory activities across Gilead’s therapeutic areas in South Africa. This role requires cross-functional partnerships, to ensure that all projects have the appropriate local regulatory input and guidance.

The ideal candidate has expertise in local regulatory affairs, pharmacovigilance and quality systems. Moreover, they will have had extensive exposure across the Pharmaceutical or Biotechnology sector.

Role and Responsibilities:

• Develop, propose and agree local registration strategies based on regulatory requirements, product knowledge and company strategy.
• Primary contact with national authorities 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 in collaboration with key stakeholders.
• Represent the Regulatory Function at internal and external meetings. Actively 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 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 collaborating 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.

Quality

• Act as Gilead ‘Qualified Person’ to ensure that a Quality Management System is established and maintained for the product distribution model operating in country.

Pricing and Reimbursement

• Prepare or lead all aspects of the preparation of the required regulatory documentation to support the agreed pricing and reimbursement strategies.

General Management and Administration

• An active member of the South African office leadership team.

Specific Education & Experience Requirements:

• Bachelor’s Degree in Pharmacy and registered with the South African Pharmacy Council.
• Experience in Regulatory Affairs in the pharmaceutical industry and Research & Development companies.
• Long-standing experience in directly interacting with Regulatory Agencies
• Strong background with dossier submissions.
• Positive relationship building skills; proven leadership coupled with the ability to work well with people at all levels and across all functions of the organization.
• Outstanding 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.

Company Core Values

• Integrity
• Teamwork
• Excellence
• Accountability
• Inclusion

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