Manager - Regulatory Affairs

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism. Our core values:
Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents, create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

• 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 & strengthen 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 stakeholders 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.

We value people from different backgrounds. Could this be your story? Apply today or visit  to read more about us and the journey of Julphar