Regulatory Affairs Specialist - West Gulf

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Job Description

OBJECTIVES:

• Responsible for directing all day to day  regulatory affairs activities in the assigned countries within Oman, Bahrain & Qatar countries to ensure compliance with all regulations.
• Implements regulatory strategies for the earliest possible product approvals and ensures the timely creation, preparation, and achievement of organized valid regulatory submissions.
• Ensure close follow ups with respective agents across assigned countries to ensure timely submissions and approvals.

ACCOUNTABILITIES:

• Ensure compliance with all regulatory requirements and company SOPs.
• Maintain regulatory documentation database and Provide accurate reviews of data and reports.
• Ensure accurate and timely submissions to regulatory agencies.
• Timely query handling: co-ordination and follow-up with regulatory authorities.
• Manage and review change control documents.
• Provide input /assessment on new regulatory quality changes in a timely manner.
• Collaborate cross-functionally with all departments to meet business objectives and address/communicate any regulatory issues.
• Create, review and track revisions/changes of product’s labelling.
• Good knowledge of ICH Guidelines/E-CTD Modules
• Handle national and international tenders from regulatory aspects and Support the RA Department on ad hoc projects as requested.

CORE ELEMENTS RELATED TO THIS ROLE:

• Regulatory compliance: Ensuring all activities , processes, products comply with relevant regulations and laws.
• Regulatory submissions: Preparing, compiling and submitting regulatory documents such as new drug applications, renewals and variations..
• Labelling and packaging compliance; Ensuring that product labelling and packaging meet regulatory requirements.
• Quality Assurance; collaborating with QA team to ensure the products meet quality standards.
• Cross Functional Collaboration; collaborating with various departments at LOC and Global side to ensure smooth regulatory plan execution.
• Communication with distributors and health authorities by responding to inquiries, providing information when requested and follows up on the ongoing projects.

DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise

Fully aware of the technical part of the e-CTD submissions and how to translate the regulations into workable plan to ensure smooth files preparation as per the regulations.

Leadership

Strong communication skills to effectively convey ideas, provide guidance when needed.

Interaction

Collaboration: ability to work effectively with others, build relationships and have team spirit.

Active listener; ability to listen attentively, understands others perspectives and communicate effectively.

Innovation

Creativity: ability to think out of the box, generate new ideas and propose solutions to challenges

Problem solving skills; ability to identify problems , analyze root cause and develop creative solutions

Complexity

Adaptability; ability to adapt to changing structures and responsibilities and environments.

System thinking; capacity to understand complex systems

Resilience; ability to bounce back from setbacks, learn from failures

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:  

• Bachelor degree in a scientific medical background.
• Arabic and English speaker.
• 4-5 years of total experience with extensive GCC countries experience in a medium to large size reputable organization/s for pharmaceutical product,
• In-depth understanding of regulation in the GCC countries countries.
• In depth experience in e-CTD requirements and submissions process across GCC countries.
• Ability to drive multiple simultaneous projects, able to work under pressure.
• Ability to work independently and in a fast-paced environment with demonstrated ability to deal with competing tasks and demands.
• Ability to meet deadlines with consistently superior work product.
• Ability to focus on priorities assigned by line manager and deliver superior priorities.
• Excellent time management and projects tracker into excel sheet presentation skills.
• Excellent verbal and written communication skills.
• Flexibility &  ability to work on global regulatory system.
• A detail -oriented individual with a ‘can do’ attitude and team collaboration
• Focused, energetic, and enthusiastic.
• IT-savvy and process orientation.

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Takeda is committed to providing a safe and healthy working environment and to having a workforce that is as diverse as the patients we serve and the communities where we’re based. To achieve that inclusivity, we embrace and celebrate our differences, respecting and valuing each other regardless of race, color, sex, age, national origin, religion, gender identity, sexual orientation, disability or physical appearance.  

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