Manager - Regulatory Affairs

• Responsible for the day-to-day operational implementation and execution of the submission/approval plans of the markets where Julphar is operational.
• Manage and lead the life cycle management team and drug products (Renewals and variations).
• Lead & strength the life cycle management team in terms of technical and scientific aspects to overcome the dynamic regulatory challenges worldwide.
• Establish and strengthen proactive dialogue and communication strategies with regulatory authorities for life cycle management of drug products.
• Evaluates with different stake holders both internally and externally timely submission of license renewal/variation and ensure the free flow of supply of Julphar portfolio to different markets.
• Maintains and safeguards advanced corporate database of all dossiers submitted approved for future reference.
• Provides regulatory strategy/requirements as well as innovative business ideas.
• Monitors the monthly Regulatory Affairs performances as per the department objectives.
• Liaise with specialized individuals and sections within RA to meet submission requirements.
• Collaborate with PDL, QA, QC, Tender, Marketing and Accounts Departments to gather the relevant information required for submissions.
• Perform other related duties/additional tasks as required by management.
• Managing all parts of a regulatory project including overall strategy, resource, costs, time, and clients.
• Assuming responsibility for a functional area or having a unique contribution to a department and choosing the method and processes of work to achieve overall objective.

• Bachelor of Pharmacy with min 10 years of experience.
• Proficient PC Skills: Word, Excel; knowledge of SAP software
• An applied understanding of a specific regulatory discipline and the principles, concepts and theories governing Regulatory Affairs, has experience in successful submission, approval, and post-approval management in health agencies.
• Full functional knowledge of regulatory requirements (Directives, Regulations, and Guidance) pertaining to the development and registration of drug products in multiple regions and industry best practices for drug development.
• Excellent organization skills and ability to manage multiple highly confidential projects, Proven history of finding solutions to challenging drug development issues and developing innovative regulatory strategies.
• Excellent understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, regulatory environment, project management and medical terminology.

Julphar