Specialist Regulatory Affairs
Ras al-Khaimah, United Arab Emirates
Job Description
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The Sr. Specialist \xe2\x80\x93 RA must ensure to adhere with the cGMP principles and to maintain them in an effective manner.
The regulatory affairs Sr. specialist work description entails assisting in obtaining and maintaining government approval for materials such as drugs, medical devices, nutritional products, and several other related materials. Regulatory affairs specialists are also responsible for collecting, gathering, compiling, and preparing the dossier needed for registration and submission to regulatory agencies.
The regulatory affairs Sr. specialist will report to Manager\xe2\x80\x93 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 & Key Result Areas
The major duties, tasks, and responsibilities that typically make up the regulatory affairs specialist job description are listed below:
Core Competency
The regulatory affairs Sr. specialist work description entails assisting in obtaining and maintaining government approval for materials such as drugs, medical devices, nutritional products, and several other related materials. Regulatory affairs specialists are also responsible for collecting, gathering, compiling, and preparing the dossier needed for registration and submission to regulatory agencies.
The regulatory affairs Sr. specialist will report to Manager\xe2\x80\x93 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 & Key Result Areas
The major duties, tasks, and responsibilities that typically make up the regulatory affairs specialist job description are listed below:
- Explaining regulations, policies, or procedures
- Ensuring adequate compliance with regulations
- Advising others on matters that are related to regulatory processes and compliance
- Providing correct and accurate technical review of data or reports
- Overseeing the planning, coordination, and management of regulatory documentation activities
- Examining, identifying, and interpreting relevant regulatory guidelines
- Analysing and evaluating laws and regulations that apply to the process of determining the impact on company activities
- Compiling and overseeing the maintenance of regulatory documentation databases or systems
- Coordinating efforts that are related to the preparation of regulatory documents or submissions
- Developing and maintaining healthy communication with regulatory agencies regarding pre-submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions still under review.
Core Competency
- 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;
- Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.
- 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
- Must be highly organized, self-motivated to learn new things and implement them at workplace
- Bachelors (4 years) / Master\xe2\x80\x99s Degree in Pharmacy
- Minimum 4-5 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.
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Job Detail
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Job IdJD1681326
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationRas al-Khaimah, United Arab Emirates
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EducationNot mentioned