Legal Counsel - Technical Operations & Manufacturing

About the role

Arcera, a global life sciences company developing, manufacturing and commercializing medicines, is hiring a Legal Counsel for its Technical Operations and Manufacturing function in Egypt. The role provides practical legal support focused on regulatory and operational compliance, commercial contracts and risk management, based at the El Obour manufacturing site, with travel to authorities and courts as needed.

Key responsibilities

• Partner with Manufacturing, Technical Operations, Engineering, Quality and Supply Chain to give practical, business-focused legal advice.
• Draft, review and negotiate operational contracts such as supply, procurement, maintenance, engineering and service agreements.
• Advise on pharmaceutical regulations, EHS requirements and operational compliance, and monitor legal and regulatory developments.
• Assess and mitigate legal risks from manufacturing operations and projects, and prepare advice, risk assessments and management reports.
• Lead or coordinate responses to governmental and regulatory inspections, investigations and enforcement matters with Quality, Compliance and business functions.
• Support applications, filings, permits, licences and renewals, represent the company before competent authorities and coordinate external counsel when required.
• Support integration, operational improvement and manufacturing projects, and perform other assignments delegated by the Legal Director, Egypt.

Required profile

• Law degree from a recognized university.
• At least 5 years of relevant legal experience, preferably in pharmaceutical, healthcare, manufacturing or FMCG.
• Strong experience drafting and negotiating procurement, supply and licensing agreements.
• Sound knowledge of Egyptian commercial, corporate, labour and regulatory law.
• Experience supporting manufacturing, technical operations, supply chain or procurement is an advantage.
• Fluency in Arabic and English, written and spoken.

Required skills

• Contract drafting and negotiation
• Pharmaceutical and regulatory compliance
• Risk management and legal analysis
• Stakeholder management and communication