الوصف الوظيفي:
أحدث معلومات الوظائف من 1100 Mylan Pharmaceuticals Inc. لمنصب Regulatory Affairs Senior Manager. If the Regulatory Affairs Senior Manager الشاغرة في Riyadh تتوافق مع مؤهلاتك، يرجى تقديم أحدث طلب أو سيرة ذاتية مباشرة من خلال بوابة وظائف Jobkos المحدثة.
يرجى ملاحظة أن التقديم على وظيفة قد لا يكون سهلاً دائماً، حيث يجب على المرشحين الجدد استيفاء مؤهلات ومتطلبات معينة تحددها الشركة. نأمل أن تكون الفرصة المهنية في 1100 Mylan Pharmaceuticals Inc. لمنصب Regulatory Affairs Senior Manager أدناه تتوافق مع مؤهلاتك.
Regulatory Affairs Senior ManagerAplikujالموقعs: Riyadh-Officetime type: Praca na pełny etatنُشر في on: Opublikowano dzisiajjob requisition id: RVIATRIS ARABIA LIMITED "LLC"Viatris to globalna firma medyczna, która jest wyjątkowo pozycjonowana, by zniwelować tradycyjne podziały między lekami generycznymi a markami, łącząc najlepsze z obu, aby bardziej kompleksowo odpowiadać na potrzeby zdrowotne na całym świecie. Z misją umożliwienia ludziom na całym świecie zdrowszego życia na każdym etapie życia, zapewniamy dostęp na dużą skalę, obecnie dostarczając wysokiej jakości leki około miliardowi pacjentów rocznie i dotykając wszystkich momentów życia - od narodzin po koniec życia, od ostrych schorzeń po choroby przewlekłe. Zostaliśmy uwzględnieni na wielu listachnagród, które pokazują wpływ, jaki wywieramy. المنصب SUMMARY Lead, manage, execute and provide strategic direction to KSA. Provide oversight for KSA, the الدولة team for the Viatris portfolio and strategic initiatives to develop and execute regulatory strategies, processes, and plans in support of new registrations and post approval submissions. To ensure regulatory input is communicated to the regional and local Commercial, Supply Chain and Quality teams for promoted and development products and the implementation of special projects. To ensure and supervise that regulatory documentation meets relevant regulatory requirements. To apply knowledge and best interpretation of regulatory requirements in the assigned countries to enable efficient and effective registration of medicinal products consistent with the supported regions commercial objectives. To ensure business continuity between vertical regulatory teams, الدولة Regulatory staff and distributors supporting Regulatory activities for Viatris portfolio. المنصب RESPONSIBILITIES Direct line management of Viatris RA team as directed. Requires hands on execution in market where the role is located. Apply regulatory expertise for assigned الدولة to enable preparation of high quality documentation and assure compliance with departmental procedures. Ensure development of KSA Market Regulatory Team and and maintain knowledge base of الدولة requirements and regulatory environment. To build inالدولة relationship with stakeholders/partners and assist team members to do the same with local stakeholders/partners and ensure communication/clarity of regulatory strategy and timelines. Manage the performance of direct reports to achieve agreed objectives and to identify and address training and development needs. Provide input to the regulatory strategy for the development of products in-line with business objectives, ensuring strategies are adequately reflected in relevant الدولة plans (e.g., business development or manufacturing supply) and alignment is achieved between regulatory activities and relevant الدولة business/commercial plans. Implement team spirit/activities in alignment with Viatris' culture and values to help retain/attract talents Provide input and liaise with Global Regulatory, Vertical Regulatory Teams, Viatris Global supply, Submissions Management, Market Regulatory Teams, Labeling CoE, Artwork coordinators, Cluster/Market, and any other key stakeholders to ensure the filing strategies are defined and executed and HA's requirements are met, ensuring a submission ready dossier. Responsible that the appropriate regulatory systems and database are updated in a timely manner when changes occur. Ensure a submission planning and forecasting tool is utilized to update timelines. Facilitating and support all product lifecycle regulatory work, and liaise with Vertical Regulatory Teams, Submissions Management, Cluster/Market, and any other key stakeholders. Ensure and oversee the preparation of regulatory strategies and plans for assigned countries, including review of existing regulatory guidelines and relevant literature. Ensure adequate input to the local/regional Viatris commercial strategic planning process as appropriate. Advise, where necessary, with direct reports and Vertical Regulatory teams the receipt, distribution and response to regulatory queries from target countries, consistent with procedures and including liaison with response team members to ensure that response targets are met. Develop detailed understanding of regulatory guidelines and technical requirements and support maintenance of regulatory requirements database and assist Regulatory Policy with assessing the regulatory environment and identifying relevant trends. Regularly follow up with Market Regulatory Teams and distributors (if applicable) on progress of registration submission and approval activities, and ensure line management are advised of progress in regulatory filings. ORGANIZATIONAL RELATIONSHIPS Reports to the Head of MENA Regulatory Affairs. Direct Reports: الدولة Regulatory Teams Key stakeholders: Middle East الدولة and Cluster Commercial Leads, Supply Chain and Quality , Vertical Regulatory Leads. RESOURCES MANAGED Financial Accountability N.A. N.A. Supervision Indicate the typical number of Colleagues managed. Include direct & indirect reports, matrix responsibility and or additional resources (i.e. contingent workers), where applicable. If not applicable, indicate NA. Approx av 3-5 EDUCATION Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.MSc, MBA or PhD may be an advantage Saudi National. Licensed from SCFHS (Saudi Commission for Health Specialties). EXPERIENCE Experience in regulatory affairs, preferably in human medicines - minimum 10 years of experience. Demonstrate regulatory experience with a pharmaceutical الشركة with proven examples of contribution. Proven ability to manage complex Regulatory issues and consistently deliver to time, cost and quality standards. Regional Regulatory experience including knowledge of NDA, sNDA, ANDA, MAA submission processes and Product lifecycle management processes. Demonstrate experience of effective delivery in a complex matrix environment. Knowledge of Regional and Global Regulatory environment Technically competent to understand CMC submissions, interpret and communicate requirements, and identify potential risks. Knowledge of drug development, regulations and guidelines Strong leadership and management qualities, including excellent communication, negotiation, and interpersonal skills Understanding of pharmaceutical industry, clinical trials and pharmacovigilance Knowledge and understanding of quality systems, processes, audit and inspection Ability to influence at all levels in the organization Able to simplify complex ideas and processes Team player Growth focused Analytical thinking Talent development Change agile
معلومات الوظيفة:
- الشركة: 1100 Mylan Pharmaceuticals Inc.
- المنصب: Regulatory Affairs Senior Manager
- مكان العمل: Riyadh
- الدولة: SA
كيفية تقديم الطلب:
بعد قراءة وفهم المعايير ومتطلبات الحد الأدنى من المؤهلات الموضحة في معلومات الوظيفة Regulatory Affairs Senior Manager at the office Riyadh أعلاه، أكمل فوراً ملفات طلب الوظيفة مثل خطاب التقديم، السيرة الذاتية، نسخة من الشهادة الجامعية، كشف الدرجات، والملاحق الأخرى كما هو موضح أعلاه. أرسلها عبر رابط الصفحة التالية أدناه.
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