Regulatory Affairs Associate

الوصف الوظيفي
This is a Contract role under Manpower Group - 12 months renewable contract
REGULATORY AFFAIRS ASSOCIATE

Primary Responsibilities
• Support local regulatory team and regional AfME organization in the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management.
• Develop strong partnerships with in-country (e.g. BU leads, Market Access, Marketing, Supply Chain) and with above country (e.g. GEP RA Strategists, Submission and labeling/artwork Hubs,) to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and life-cycle optimization.
• Responsible for their own personal development and performance to achieve company objectives and agree training and development needs with Country/Cluster Regulatory Manager to develop and enhance individual capabilities and capacities
• Responsible for developing and enhancing relationships with key external agencies (HA’s/BoH, RKOL’s, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product.
• Understand local regulations and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies.
• Maintain licenses (e.g. Marketing Authorizations) in compliance with local regulations by ensuring that corporate regulatory processes, SOP’s and systems are followed ensuring training in P2L are completed 100% (systems and procedures).
• Maintain compliance in regulatory systems (e.g.: GDMS, GRS, AT, RRBD, RRS, CMC change control, product labelling, etc.) at 100%.
• Where needed, oversee and manage the completion of CTA, NDA and Lifecycle (LC) submissions and approvals as per established GEP RA performance metrics.

المهارات
Qualifications (i.e., preferred education, experience, attributes)

Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
MSc, MBA or PhD may be an advantage
less than 3 years of experience (Associate role)
Fluency in English and Arabic
Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
Proven ability to manage complex regulatory issues.
Proven ability to consistently deliver to time, cost and quality standards.
Regional/Country regulatory experience including submission processes and product life cycle management activities.

تفاصيل الوظيفة
منطقة الوظيفة دبي, الإمارات العربية المتحدة
قطاع الشركة وكالات التوظيف/التوظيف
طبيعة عمل الشركة صاحب عمل (القطاع الخاص)
الدور الوظيفي الخدمات المساندة
نوع التوظيف دوام كامل
الراتب الشهري غير محدد
عدد الوظائف الشاغرة غير محدد
المرشح المفضل
المستوى المهني متوسط الخبرة

*** تقدم على الرابط التالي : Apply on the following link ***
https://www.bayt.com/ar/uae/jobs/regulatory-affairs-associate-3911741/