Legal Specialist

Position OverviewWe are seeking a Legal Specialist to lead legal and execution for our industrial vaccine company (VIC), covering manufacturing, regulatory, HR, intellectual property, supply, and corporate matters. This role advises executive leadership, quality, regulatory affairs, and commercial teams, works independently on complex matters, manages outside counsel, and mentors junior legal staff.Employment type: Full-timeKey ResponsibilitiesRegulatory, Quality, and ComplianceAdvise on legal requirements for vaccine development, licensure, manufacturing, and distribution across relevant authorities (e.g., FDA, EMA, SFDA, WHO prequalification)Provide guidance on GMP, GxP, clinical trial regulations, biosafety, and pharmacovigilance obligationsSupport the company through inspections, audits, recalls, and regulatory enforcement matters, including interactions with health authoritiesAdvise on batch release, lot-testing, product quality complaints, and adverse event reporting from a legal perspectiveOversee compliance programs covering anti-bribery, healthcare professional interactions, pricing, and conflict of interestTrack legislative and regulatory changes (e.g., vaccine policy, immunization programs, local manufacturing requirements) and advise leadership on strategic impactManufacturing, Supply, and Commercial ContractingLead negotiation of high-value agreements, including supply and offtake agreements, government and public-sector tenders, distribution, cold-chain logistics, and CMO/CDMO agreementsNegotiate quality agreements, technology transfer, and fill-finish arrangementsStructure agreements with governments, ministries of health, and international procurement bodies (e.g., UNICEF, Gavi, PAHO)Advise on supply chain risk, force majeure, product liability allocation, and indemnitiesManage raw material, equipment, and single-source supplier contracts, including facility construction and capital projectsEstablish and continuously improve contracting playbooks, templates, and approval workflowsIntellectual Property StrategyOwn IP strategy in partnership with R&D, aligning patent filings with pipeline and commercial prioritiesDirect outside patent counsel on prosecution, maintenance, oppositions, and portfolio management (antigens, adjuvants, platforms, manufacturing processes, formulations)Lead freedom-to-operate analyses and IP due diligence, including platform technologies such as mRNA, viral vectors, and recombinant protein systemsNegotiate in-licensing and out-licensing, cell line and adjuvant licenses, and technology transfer arrangementsProtect trade secrets and manufacturing know-how, and manage employee and consultant IP assignment frameworksClinical Trials, Product Liability, and Public HealthNegotiate clinical trial agreements with CROs, sites, and research institutionsAdvise on informed consent, ethics committee requirements, and clinical trial insurance and indemnificationManage product liability exposure and advise on national vaccine injury compensation and liability frameworksAdvise on emergency use authorizations, pandemic preparedness arrangements, and public health emergency contractingSupport technology transfer and capacity-building partnerships aimed at local and regional vaccine productionData Protection and BiosafetyOversee data protection compliance (e.g., GDPR, PDPL, HIPAA) for clinical trial, patient, and immunization data, including cross-border transfersAdvise on biosafety, biosecurity, environmental, health and safety, and waste handling requirements for industrial productionAdvise on import/export controls, customs, and cross-border shipment of biological materialsCorporate Governance, Transactions, and DisputesAdvise the board and executive team on governance, fiduciary duties, and corporate housekeepingSupport fundraising, strategic partnerships, joint ventures, government-backed investments, and M&A, including due diligenceManage litigation, arbitration, and disputes strategy, directing external counsel and controlling legal spendManage the legal budget and external counsel panelLeadership and Business PartneringServe as strategic legal advisor to senior leadership on risk and decision-makingMentor and supervise junior legal team membersDeliver legal training to scientific, manufacturing, quality, and commercial teamsRepresent the company in negotiations with governments, regulators, partners, investors, and institutionsQualificationsRequiredLaw degree (LL.B. / J.D. or equivalent); LL.M. strongly preferred[3–7] years of post-qualification experience, with significant time in vaccines, pharma, biologics, life sciences manufacturing, or a top-tier law firm with a life sciences practiceProven track record negotiating complex supply, licensing, technology transfer, and manufacturing agreementsSolid understanding of regulatory frameworks for vaccines and biologics, including GMP and licensureStrong knowledge of patent law and IP strategy in the life sciences sectorExperience with cross-border transactions and multi-jurisdictional issuesDemonstrated ability to work independently and manage outside counselExcellent drafting, negotiation, and communication skillsPreferredScientific background or advanced degree in biology, immunology, microbiology, biochemistry, or a related fieldAdmitted to practice in [jurisdiction]Experience with government tenders, public procurement, and international procurement agenciesExperience with product liability, recalls, or regulatory enforcement in the pharmaceutical sectorExperience with industrial or capital projects, such as building or scaling manufacturing facilitiesExperience supporting financings, IPOs, or M&A in a life sciences companyKnowledge of healthcare data privacy and pandemic-related legal frameworksFluency in [English / Arabic / other languages]Skills and CompetenciesStrategic thinking with strong commercial judgment and pragmatic, risk-based adviceAbility to translate complex scientific, manufacturing, and regulatory concepts into clear legal guidanceConfident negotiator able to influence senior stakeholders, governments, and external partiesCalm and decisive in high-pressure situations such as recalls, inspections, and public health emergenciesLeadership and mentoring skillsExceptional organization and ability to prioritize across multiple high-stakes mattersIntegrity, discretion, and high ethical standardsWhat We OfferCompetitive salary, bonus, and benefits package [equity/LTIP if applicable]Visible, high-impact role with direct access to executive leadershipOpportunity to contribute to public health and vaccine access at scaleOpportunity to shape the legal function of a growing industrial vaccine manufacturerProfessional development and continuing legal education supportCollaborative, mission-driven environment