Typical Accountabilities
• Ensures that key business needs identified by the project are efficiently and effectively addressed.
• Develops and maintains strong partnerships with key global external partners, i.e., Regulatory Health Authorities, Industry Reps., etc with extensive focus on Kuwait HA partnership.
• Identifies required project resources and communicates these to line management, ensuring stakeholders’ awareness about changing project timelines.
• Leads and/or participates in special critical projects (e.g. eRegulatory strategy).
• Provides knowledgeable, professional, and interactive representation on industry or internal forums to ensure AZ’s Regulatory interests and requirements are communicated and incorporated into key decisions.
• Evaluate regulatory risks of corporate policies.
• Develop new regulatory policies, procedures and SOPs and train key personnel on them.
• Assist in the development and advancement of policy and procedures for regulatory affairs and... compliance to establish a compliant culture within the organization.
• Utilize technical regulatory skills to propose strategies on complex issues.
• Monitor emerging issues and identify solutions.
• Provide regulatory input to product lifecycle planning.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Determine submission and approval requirements.
• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management.
• Assist in regulatory due diligence.
Education, Qualifications, Skills and Experience Essential
• Completed higher education (pharmaceuticals, medicine, biotechnology).
• >7yrs and at least 3 yrs in RA. Mgr’s role managing full regulatory submission life-cycle for simple-medium complex projects).
• Solid knowledge of local and international (For RA Mgr) regulatory standards, requirements and practices, understanding of business principles, logistics, finance, excellent communication skills, project and process management, problem solving skills.
• Excellent relation with Kuwait HA.
Desirable
• Very Good negotiation skills.
• Very Good working capabilities with global team.
• Very good Knowledge of AstraZeneca business and processes.
• Very good Project Management skills
Abu Dhabi - United Arab Emirates

Salary Criteria