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Job Ref. ID:  40365 
Job Title: Specialist
Division: REGULATORY AFFAIRS
Country: UNITED ARAB EMIRATES
Work Location: UAE (RAK head office)
Job Type: Specialist
Employment Type: Full Time Employment (Un-limited Contract)
Job Description:
Purpose: The Specialist – RA must ensure to adhere with the cGMP principles and to maintain them in an effective ‎manner. ‎ Responsible for Variation & planning.‎ Responsible to notify the variations to Health authority.‎ Follow up different quires and additional requirements of Authority.‎ Follow up the Requested Documents from different departments.‎ Perform other related duties/additional tasks as required by management.‎ The Specialist – RA will report to the Manager – Regulatory Affairs and efficiently conduct all duties and ‎responsibilities assigned and or delegated by the Manager. Must ensure to support RA team members as per ‎the need of the function.
Key responsibilities & Accountability: • Gap analysis of documents required to file planned variation in GCC market • Preparation of the variation files for GCC market as per their current guidelines and the ‎preparation of the technical file for the drug control laboratory. Notification of the Minor and ‎Major Changes regarding the formula (active & inactive ingredients), finished product ‎specifications, additional pack sizes, change in the packaging materials (leaflets, inner & outer ‎packs), extension of shelf life, change in the API manufacturer and storage condition.‎ • Communication with internal and external departments for fulfillment of the requirements. ‎ • Preparation of the required certificates & arrange for the legalization as per the requirements ‎of the different countries, to be included in our variation Files.‎ • Following up with the requested documents from different departments.‎ • Compilation of variation and baseline files as per country specific guidelines to get approval.‎ • Follow up different queries and additional requirements to finalize the variations in GCC ‎market to get the approval.‎ • Manage review of internal document system for compliance to Regulatory commitments and ‎regulations.‎ • Assuring responsibility for a functional area or have a unique contribution to the team and ‎department.‎ • Relates/contributes to the development of internal policies, processes and procedures and ‎supporting the progression and maintenance of the Pharmaceutical portfolio at large.‎ • Providing support whenever required to achieve additional tasks as per the manager's ‎request.‎
 Qualifications: 
   - Education • Bachelors (4 years) / Master’s Degree in Pharmacy or scientific field.‎
   - Experience: • Minimum 2-3 years of experience working in similar role in Pharmaceuticals industry • A Strong Background in Regulatory Affairs and its related activities like - New Registrations, variations ‎renewals etc.‎
   - Training:
Key Competencies: • High on communication and collaboration, having an ability to manage multiple stakeholders at a ‎time • In terms of competency you are highly result oriented with strong sense of accountability & ‎ownership.‎ • Must be able to manage tasks and priorities and easily adapt to changing situations. ‎ • Good command in English (Communicating, writing and speaking)‎ • Good prioritizing skills and being able to make a just decision also in case of (time) pressure; • Strong organizational skills and the ability to multitask • Demonstrated ability in working independently and as part of a team • Must be able to work in a cross-functional environment interacting with other internal departments ‎and external vendors. • Must have a teamwork attitude & ability to apply common sense understanding to carry out multi-‎step instructions • Ability to write or speak in the English language and communicate information effectively in one-on-‎one and in a group of employees within the organization.‎ • Must be highly organized, self-motivated to learn new things and implement them at workplace ‎  
Technical Competencies: • Has strong knowledge of regulatory guidance in multiple regions and industry best practices for drug ‎development. ‎ • Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.‎ • Must be able to communicate technical, scientific, and regulatory information, both written and ‎verbally • Ability to work in a detail-oriented manner • Ability to meet attendance standards. At times it may be necessary to work additional hours in order ‎to accomplish the required tasks to meet deadlines.‎  
 

 
 

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