الوصف الوظيفي
Our Client a leading Pharma company is looking for a Regulatory Affairs Specialist.
This is a contract role under ManpowerGroup - 12 months renewable
• Direct Report to Regulatory Gulf Team Leader
• Works closely with Regulatory Senior Associate teams in country and other stakeholders
Position Purpose
The Regulatory Specialist will support the development of the strategic direction and work closely with Country based Regulatory teams and above country regulatory teams to develop and execute regulatory strategies and plans for the country.
Primary Responsibilities
• Support the local Regulatory team in the development of regulatory strategies to support the registration of new products, line extensions, major variations and lifecycle management. Provide strategic regulatory input to support for meeting local business objectives.
• Develop strong partnerships with in-country (e.g. Market Access, Marketing, Supply Chain) and with above country (e.g. Country Strategists, GCMC, 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, leadership and performance to achieve company objectives and agree training and development needs with Regulatory Gulf Team Leader 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.
• Effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. 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 are completed 100% (systems and procedures).
• Maintain compliance (Systems, CMC change control, product labelling, etc.) at 100%.
• Where needed, oversee and manage the completion of NDA and Lifecycle (LC) submissions and approvals as per established performance metrics.
المهارات
Technical Skill Requirements
- Knowledge of the Regional and Global regulatory environment and how this impacts regulatory strategy and implementation
Understanding of regulatory agency philosophies, culture, and developing trends in the regulatory environment. Experience in preparing and submitting NDA’s, variations and LC submissions. Working with and influencing, opinion leaders, external organizations and facilitating approval of submissions. Is driven to continually enhance regulatory expertise, both locally and globally.
- Knowledge of drug development practice, rules, regulations and guidelines
Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to Regional regulatory strategies and implementation plans. Maintains internal and external networks to learn in advance about new regulatory trends or changes impacting the Regulatory, Medical and overall Business strategy
- Strategic Thinker
Provides strategic contribution and anticipates what RA needs to contribute to develop and achieve business objectives. Effectively explores alternative regulatory strategies and positions to reach outcomes that gain the support and acceptance of all parties.
- Communication skills
Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand the message.
- Negotiation skills
Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations. Has built a strong relationship with the local health agency and other relevant stakeholders (rKOL’s) and pro-actively manages issues with the HA’s and other key external stakeholders.
- Problem Solving
Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed upon solutions.
- Detailed Orientated
Can be thorough and complete with high quality.
- Project Management
Can manage complex and multiple projects
Qualifications
• Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences
• Appropriate Regulatory Experience – minimum 1-3 years experience
• Fluency in both English and Arabic
• Proven ability to manage complex regulatory or drug development issues.
• Proven ability to deliver to time, cost and quality standards.
• Regional/Country regulatory experience including submission processes and product life cycle management activities.
• Comfortable acting in a wide range of team roles in the wider project interest.
تفاصيل الوظيفة
منطقة الوظيفة دبي, الإمارات العربية المتحدة
قطاع الشركة وكالات التوظيف/التوظيف
طبيعة عمل الشركة صاحب عمل (القطاع الخاص)
الدور الوظيفي إدارية
نوع التوظيف دوام كامل
الراتب الشهري غير محدد
عدد الوظائف الشاغرة غير محدد
الرقم المرجعي للوظيفة JB3849655
المرشح المفضل
المستوى المهني متوسط الخبرة
https://www.bayt.com/ar/uae/jobs/regulatory-affairs-specialist-3849655/