Manager - Regulatory Affairs

<p><p>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. </p> <p>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. </p> <h3>Roles and Responsibilities </h3> <ul> <li>Responsible for the day-to-day operational implementation and execution of the submission/approval plans of the markets where Julphar is operational. </li> <li>Manage and lead the life cycle management team and drug products (Renewals and variations). </li> <li>Lead & strength the life cycle management team in terms of technical and scientific aspects to overcome the dynamic regulatory challenges worldwide. </li> <li>Establish and strengthen proactive dialogue and communication strategies with regulatory authorities for life cycle management of drug products. </li> <li>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. </li> <li>Maintains and safeguards advanced corporate database of all dossiers submitted approved for future reference. </li> <li>Provides regulatory strategy/requirements as well as innovative business ideas. </li> <li>Monitors the monthly Regulatory Affairs performances as per the department objectives. </li> <li>Liaise with specialized individuals and sections within RA to meet submission requirements. </li> <li>Collaborate with PDL, QA, QC, Tender, Marketing and Accounts Departments to gather the relevant information required for submissions. </li> <li>Perform other related duties/additional tasks as required by management. </li> <li>Managing all parts of a regulatory project including overall strategy, resource, costs, time, and clients. </li> <li>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. </li> </ul> <h3>Qualification/Functional Knowledge </h3> <ul> <li>Bachelor of Pharmacy with min 10 years of experience. </li> <li>Proficient PC Skills: Word, Excel; knowledge of SAP software </li> <li>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. </li> <li>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. </li> <li>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. </li> <li>Excellent understanding of pharmaceutical development, clinical research, study design, biostatistics, pharmacokinetics, regulatory environment, project management and medical terminology. </li> </ul> <p>We value people from different backgrounds. Could this be your story? Apply today or visit read more about us and the journey of Julphar </p> </p> #J-18808-Ljbffr