Vaccine Industrial Company — الرياض - منطقة الرياض — دوام كامل
Position Overview
We 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-time
Key Responsibilities
Regulatory, Quality, and Compliance
• Advise 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 obligations
• Support the company through inspections, audits, recalls, and regulatory enforcement matters, including interactions with health authorities
• Advise on batch release, lot-testing, product quality complaints, and adverse event reporting from a legal perspective
• Oversee compliance programs covering anti-bribery, healthcare professional interactions, pricing, and conflict of interest
• Track legislative and regulatory changes (e.g., vaccine policy, immunization programs, local manufacturing requirements) and advise leadership on strategic impact
Manufacturing, Supply, and Commercial Contracting
• Lead negotiation of high-value agreements, including supply and offtake agreements, government and public-sector tenders, distribution, cold-chain logistics, and CMO/CDMO agreements
• Negotiate quality agreements, technology transfer, and fill-finish arrangements
• Structure 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 indemnities
• Manage raw material, equipment, and single-source supplier contracts, including facility construction and capital projects
• Establish and continuously improve contracting playbooks, templates, and approval workflows
Intellectual Property Strategy
• Own IP strategy in partnership with R&D, aligning patent filings with pipeline and commercial priorities
• Direct 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 systems
• Negotiate in-licensing and out-licensing, cell line and adjuvant licenses, and technology transfer arrangements
• Protect trade secrets and manufacturing know-how, and manage employee and consultant IP assignment frameworks
Clinical Trials, Product Liability, and Public Health
• Negotiate clinical trial agreements with CROs, sites, and research institutions
• Advise on informed consent, ethics committee requirements, and clinical trial insurance and indemnification
• Manage product liability exposure and advise on national vaccine injury compensation and liability frameworks
• Advise on emergency use authorizations, pandemic preparedness arrangements, and public health emergency contracting
• Support technology transfer and capacity-building partnerships aimed at local and regional vaccine production
Data Protection and Biosafety
• Oversee data protection compliance (e.g., GDPR, PDPL, HIPAA) for clinical trial, patient, and immunization data, including cross-border transfers
• Advise on biosafety, biosecurity, environmental, health and safety, and waste handling requirements for industrial production
• Advise on import/export controls, customs, and cross-border shipment of biological materials
Corporate Governance, Transactions, and Disputes
• Advise the board and executive team on governance, fiduciary duties, and corporate housekeeping
• Support fundraising, strategic partnerships, joint ventures, government-backed investments, and M&A, including due diligence
• Manage litigation, arbitration, and disputes strategy, directing external counsel and controlling legal spend
• Manage the legal budget and external counsel panel
Leadership and Business Partnering
• Serve as strategic legal advisor to senior leadership on risk and decision-making
• Mentor and supervise junior legal team members
• Deliver legal training to scientific, manufacturing, quality, and commercial teams
• Represent the company in negotiations with governments, regulators, partners, investors, and institutions
Qualifications
Required
• Law 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 practice
• Proven track record negotiating complex supply, licensing, technology transfer, and manufacturing agreements
• Solid understanding of regulatory frameworks for vaccines and biologics, including GMP and licensure
• Strong knowledge of patent law and IP strategy in the life sciences sector
• Experience with cross-border transactions and multi-jurisdictional issues
• Demonstrated ability to work independently and manage outside counsel
• Excellent drafting, negotiation, and communication skills
Preferred
• Scientific background or advanced degree in biology, immunology, microbiology, biochemistry, or a related field
• Admitted to practice in [jurisdiction]
• Experience with government tenders, public procurement, and international procurement agencies
• Experience with product liability, recalls, or regulatory enforcement in the pharmaceutical sector
• Experience with industrial or capital projects, such as building or scaling manufacturing facilities
• Experience supporting financings, IPOs, or M&A in a life sciences company
• Knowledge of healthcare data privacy and pandemic-related legal frameworks
• Fluency in [English / Arabic / other languages]
Skills and Competencies
• Strategic thinking with strong commercial judgment and pragmatic, risk-based advice
• Ability to translate complex scientific, manufacturing, and regulatory concepts into clear legal guidance
• Confident negotiator able to influence senior stakeholders, governments, and external parties
• Calm and decisive in high-pressure situations such as recalls, inspections, and public health emergencies
• Leadership and mentoring skills
• Exceptional organization and ability to prioritize across multiple high-stakes matters
• Integrity, discretion, and high ethical standards
What We Offer
• Competitive salary, bonus, and benefits package [equity/LTIP if applicable]
• Visible, high-impact role with direct access to executive leadership
• Opportunity to contribute to public health and vaccine access at scale
• Opportunity to shape the legal function of a growing industrial vaccine manufacturer
• Professional development and continuing legal education support
• Collaborative, mission-driven environment