Regulatory Affairs Specialist - East Gulf & Levant
Takeda
- Egypt
- Permanent
- Full-time
- 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 .
- 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.
- 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.
- 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.