Job Ref. ID:
UNITED ARAB EMIRATES
UAE (RAK head office)
Full Time Employment (Un-limited Contract)
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.
• Bachelors (4 years) / Master’s Degree in Pharmacy or scientific field.
• 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.
• 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
• 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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