Regulatory Affairs Associate

2 weeks ago


Dubai, United Arab Emirates Novartis Full time

As a global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. We're committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage.
We are looking for a Regulatory Affairs Associate to join our team in UAE. The role will be an External 3rd Party Contractor for a period of 18 months contract.
The role is to provide effective regulatory support to Gulf/ Levant for NTO/ Site transfer projects, regulatory maintenance, and regulatory compliance activities.
The major accountabilities of the role are defined below:

- Coordinate with project lead and stakeholders to assess and define projects scope, requirements and timelines for proper planning and execution.
- Act as a point of contact and communicate project status with countries.
- Coordinate with Logistics/ Supply Chain/ Labeling teams and manufacturing site to obtain valid artworks and implementation dates.
- Arrange and request all needed documents and certificates for files submission to Health Authorities.
- Prepare submission dossiers and publish eCTD as per countries requirements and regulations.
- Coordinate and follow-up with countries to ensure timely submission as per plan.
- Support countries in Health Authorities’ queries to secure speedy approvals.
- Update project trackers and proper archiving for documents and dossiers.
- Comply with all internal SOPs and trainings.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**Requirements**:

- Bachelor’s degree in Pharmacy, Biology or Chemistry.
- 2 years’ regulatory affairs experience in pharmaceutical industry.
- Good knowledge in Gulf/ levant regulatory requirements and compliance.
- eCTD experience
- Effective planning and organizational skills to manage complex projects.
- Strong communication and negotiation skills.
- Team oriented personality.
- Fluent in English and Arabic.

**Division**

Global Drug Development

**Business Unit**

REG AFFAIRS GDD

**Country**

Utd.Arab Emir.

**Work Location**

Dubai

**Company/Legal Entity**

NOV MIDDLE EAST FZA UAE

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Temporary

**Shift Work**

No

**Early Talent**

No



  • dubai, United Arab Emirates Associate Manager Regulatory Affairs Full time

    Associate Manager Regulatory Affairs | DubaiWe are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience.Works autonomously, but in alignment with MEA Regional Director of Regulatory Affairs & Scientific Office, to oversee day-to-day Regulatory...


  • dubai, United Arab Emirates Abu Dhabi Islamic Bank PJSC Full time

    Role Purpose:The Regulatory Affairs Manager is responsible for providing Regulatory Advisory to Business unit, management of Regulatory Affairs Unit framework and support in the day-to-day management of ADIB Ethical Conduct framework.The Regulatory Affairs Manager shall also support in maintaining a positive relationship with regulatory authorities and to...


  • dubai, United Arab Emirates Edwards Lifesciences Full time

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail...


  • Dubai, United Arab Emirates Agile Consultants Full time

    **Job Code**:047/004/746 **Location**:Dubai **Salary**:Based on experience **Industry**:Chemical Manufacturing Our client is hiring an experienced Regulatory Affairs Officer who can provide guidance and support sites with the implementation of Raw Materials such as Lubricant Additives, Epoxy Paints & Coatings, Rubber/Carbon Black, Coating, Foam, and...


  • dubai, United Arab Emirates Edwards Lifesciences Gruppe Full time

    We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience.Regulatory Affairs Associate Specialist (12 Months Contract) page is loadedRegulatory Affairs Associate Specialist (12 Months Contract) ApplylocationsUnited Arab Emirates-Dubaitime typeFull timeposted...


  • Dubai, United Arab Emirates Givaudan Full time

    Step into our world of creativity and joy! Regulatory Affairs Manager - Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with passion and creativity, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions. There’s much to learn and many to...


  • Dubai, United Arab Emirates Nazih Group Full time

    **As a regulatory affairs officer you'll be the crucial link between company, its products and regulatory authorities. You'll combine your knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a range of company, meet the required legislation.** **Job Summary**: The Regulatory Officer -...


  • dubai, United Arab Emirates Aspen Pharmacare Full time

    Regulatory Affairs and Medical Associate Jobs In Dubai | Aspen PharmacareDescription:Execution of regulatory and compliance tasks to help achieve departmental and business objectives while ensuring compliant operation within the flexibility of the regulations.Job Responsibilities:Compile and submit, in a timely manner, regulatory documents according to...


  • dubai, United Arab Emirates Novartis Full time

    Regulatory Affairs Associate Jobs In Dubai UAE 2023 | NovartisFor More Top Organization Jobs Click HereDescription:As a global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the...


  • dubai, United Arab Emirates Edwards Lifesciences Full time

    Regulatory Affairs Associate Specialist (12 Months Contract) Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside...


  • dubai, United Arab Emirates Nestlé Full time

    Regulatory and Scientific Affairs Manager Jobs In Dubai | NestléFor More Top Organization Jobs Click HereDescription:An exciting opportunity has arisen for a Regulatory Affairs Manager to join our business, this is a varied role that will works across the MENA region. In this role you will be responsible for ensuring the compliance of all local and...


  • dubai, United Arab Emirates Aecom Full time

    Manager – Regulatory and Scientific Affairs Jobs in Dubai | AecomFor More Top Organization Jobs Click HereDescription:As a Manager for Scientific and Regulatory Affairs, you are overall responsible for product stewardship, ensuring products compliance with local regulations while remaining competitive within the marketplace. This position is responsible...


  • dubai, United Arab Emirates Delivery Hero SE Full time

    Identify, monitor, analyze and report on current and future regulatory issues in all markets where talabat is active, that has direct or indirect impact on restaurant partners, or talabat commercial relation to them.Develop and execute a comprehensive public affairs strategy to support our business objectives and enhance our reputation.Manage partner...


  • Dubai, United Arab Emirates Kemipex Full time

    The Role - Ensuring consistency, completeness, and adherence to standards for all regulatory submissions. - Maintain up-to-date knowledge of international and domestic regulatory requirements. - Perform Regulatory Affairs activities ensuring compliance with FDA, and other regulatory updates on the latest changes. - Liaising with the FDA and REACH or other...


  • dubai, United Arab Emirates Nathan & Nathan Full time

    Regulatory Affairs Officer Jobs In Dubai UAE | Nathan & NathanFor More Top Organization Jobs Click HereWe are hiring a Regulatory Affairs Officer for a Pharmaceutical industry client to join their team in Dubai.Responsibilities:Responsible for coordinating and preparing CTD/eCTD submission package in accordance with regulatory requirements, and ensuring that...


  • dubai, United Arab Emirates Talabat Full time

    What’s On Your Plate?Identify, monitor, analyze and report on current and future regulatory issues in all markets where talabat is active, that has direct or indirect impact on restaurant partners, or talabat commercial relation to them. Develop and execute a comprehensive public affairs strategy to support our business objectives and enhance our...


  • Dubai, United Arab Emirates Delivery Hero SE Full time

    Identify, monitor, analyze and report on current and future regulatory issues in all markets where talabat is active, that has direct or indirect impact on restaurant partners, or talabat commercial relation to them.Develop and execute a comprehensive public affairs strategy to support our business objectives and enhance our reputation.Manage partner...


  • dubai, United Arab Emirates Procter And Gamble Full time

    Senior Regional Regulatory Affairs ManagerThe job posting is outdated and position may be filledRegulatory Strategy:• Develop and implement regulatory strategies that enable the delivery of product innovations and growth of base business to meet overall business objectivesManagement of Regulatory Team/operations in the assigned territories:• Lead the...


  • Dubai, United Arab Emirates Talabat Full time

    What’s On Your Plate? Identify, monitor, analyze and report on current and future regulatory issues in all markets where talabat is active, that has direct or indirect impact on restaurant partners, or talabat commercial relation to them.Develop and execute a comprehensive public affairs strategy to support our business objectives and enhance our...


  • dubai, United Arab Emirates Talabat Full time

    Identify, monitor, analyze and report on current and future regulatory issues in all markets where talabat is active, that has direct or indirect impact on restaurant partners, or talabat commercial relation to them.Develop and execute a comprehensive public affairs strategy to support our business objectives and enhance our reputation.Manage partner...