Regulatory Affairs Specialist

الوصف الوظيفي
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Our Research Labs are a true scientific research facility of tomorrow, and will take MSD’s leading discovery capabilities and world-class small molecule and biologics R&D;expertise to create breakthrough science that radically changes the way we approach serious diseases.
Full Description of Position:
-Manages regulatory activities for new products in order to get products to market according to company plans.-Handles timely submission and follow-up of post-approval labeling and CMC variations.-Ensures permanent compliance to local regulatory requirements and to Merck’s policies and procedures.-Demonstrates clear leadership in shaping the regulatory environment to support company objectives.-Keeps abreast on regulatory environment evolution and challenges, provides advice on resulting strategy.
New products registration (35%)
• Develops drives and finalizes all applications for GMP/new product registrations in line with local regulatory requirements and with marketing plans. Ensures submission in a timely manner and follow-up to obtain earliest approvals for new products and new indications.• During the assessment of the registration files, ensures adequate follow-up with regulatory Agencies and addresses quickly Agencies’ requests on quality, clinical and non-clinical information.• Coordinates actions effectively and proactively with MMD and marketing, in order to support products launches in due time and to avoid stock-out situations.• Coordination and close follow-up with local partners.• Participate in GMP audits with the Quality Manager or Regulatory Manager when deemed necessary.Maintenance of existing products (25%)
• Ensures timely submission and follow-up of both labeling and quality-related variations to the marketing authorizations, in cooperation with the key stakeholders: Worldwide Product Labeling, MMD, EEMEA Regulatory Affairs and Regulatory Affairs at US Headquarters (HQs).• Manages the renewal process in liaison with the HQs, ensuring that the renewal files are prepared, submitted and approved in due time.• Handles the control of packaging components artworks developed by labeling coordinator.• Works in close collaboration with Labeling Coordinator for the AMS Blue/Artwork Studio created artworks’ approval process and the follow-up of the printing process to ensure proper implementation of artworks changes.• Coordination and close follow-up with local partners.Regulatory Compliance (25%)
• Updates and implements local regulatory procedures in a timely manner, in close synergy with the Regional organization.• Trains appropriate personnel on regulatory procedures.• Plans and tracks all regulatory actions to document and ensure full compliance with relevant legislation and with internal procedures.• Coordination and close follow-up with local partners• Updates local and global systems frequently.
Shape regulatory environment (15%)
• Pro-actively shares intelligence on competitive products, generics/copies, as well as on emerging regulations.• Interacts with Ministry of Health and technical KOLs when needed.• Keeps abreast of trends and legislation, at both national and international levels.

المهارات
Qualifications
-Pharmacy Degree-English fluency-Minimum 2 years of experience in Regulatory Affairs-Clear leadership-High sense of organization-Rigor and reliability-Negotiation skills-Collaboration and active communication (high interpersonal skills)-Advanced PC use with regards to word-processing, spreadsheets, database applications, internet, sharepoints
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

تفاصيل الوظيفة
منطقة الوظيفة الرياض, المملكة العربية السعودية
قطاع الشركة الأدوية
طبيعة عمل الشركة صاحب عمل (القطاع الخاص)
الدور الوظيفي مراقبة الجودة
نوع التوظيف دوام كامل
الراتب الشهري غير محدد
عدد الوظائف الشاغرة غير محدد
المرشح المفضل
المستوى المهني متوسط الخبرة
عدد سنوات الخبرة الحد الأدنى: 2
الشهادة بكالوريوس/ دبلوم عالي
التعليم
Pharmacutical

https://www.bayt.com/ar/saudi-arabia/jobs/regulatory-affairs-specialist-3865340/