Regulatory Affairs Associate

1 week ago


Dubai, 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 followup 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, Dubai, United Arab Emirates Edwards Lifesciences Full time

    Regulatory Affairs Associate Specialist | Edwards Lifesciences DubaiEdwards Lifesciences (NYSE:EW), is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. We thrive on discovery and expanding the boundaries of medical technology, serving patients in 100+ countries, with the...


  • Dubai, Dubai, United Arab Emirates Procter & Gamble Full time

    Regulatory Affairs Associate Manager | Procter & Gamble DubaiP&G was founded more than 185 years ago as a soap and candle company. Today, we're one of the world's largest consumer goods companies and home to iconic, trusted brands, including Always, Charmin, Braun, Fairy, Febreze, Gillette, Head & Shoulders, Oral B, Pantene, Pampers, Tide, and...


  • Dubai, Dubai, United Arab Emirates Transguard Group LLC Full time

    Regulatory Affairs Associate – Pharma Industry Jobs in UAEResponsibilities:Responsible for developing and enhancing relationships with key external agencies (Health Authorities/ agents, Distributers, etc.).Manage the HA/BoH interface throughout the development and lifecycle of a product.Active participation in local trade organization and effective...


  • Dubai, Dubai, United Arab Emirates Ulrich GmbH & Co. KG Full time

    Regulatory Affairs Manager Jobs in Dubai/UAELead change in culture and facilitateregulatorycompliance.Provide continuous regionalregulatoryupdates to applicable stakeholders and partner with...Drafting, Reviewing and providing legal advice on commercial leases and related documentations.Review ongoing cases and advice management accordingly.Rational...


  • Dubai, Dubai, United Arab Emirates AstraZeneca Full time

    Gulf Regulatory Affairs Associate Director Jobs in DubaiFor More Top Organization Jobs Click HereDescription:Provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of the AstraZeneca products in Gulf. Applies knowledge of current local and global Regulatory trends to identify future regulatory...


  • Dubai, 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...


  • Dubai, Dubai, United Arab Emirates Abbott Full time

    Regulatory Affairs Intern | Abbott DubaiAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines. Our 114,000 colleagues serve people...


  • Dubai, 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, Dubai, United Arab Emirates Givaudan Full time

    Step into our world of creativity and joyRegulatory 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 learn...


  • Dubai, Dubai, United Arab Emirates Henkel Full time

    Regulatory Affairs Intern | Henkel DubaiFounded in 1876, Henkel looks back on more than 145 years of success. The company holds leading positions with its two business units in both industrial and consumer businesses thanks to strong brands, innovations and technologies such as Persil, Schwarzkopf and Loctite. Henkel, headquartered in Düsseldorf / Germany,...


  • Dubai, 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 - Product...


  • Dubai, Dubai, United Arab Emirates Kinetic Full time

    A leading Medical Devices company is actively recruiting for a Regulatory Affairs Expert to be based in Dubai, UAE.***Applicants must have a Valid Ministry of Health License.The main responsibilities will include: Ensuring compliance with regulations. Defining and executing regulatory plans and managing timelines to achieve the stated goals. Reviewing new...


  • Dubai, Dubai, United Arab Emirates Abbott Laboratories Full time

    About AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.You will...


  • Dubai, 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...

  • Regulatory Affairs

    1 week ago


    Dubai, Dubai, United Arab Emirates Zahrawi Medical Full time

    About Zahrawi Group:Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.job Brief: Responsible for all Product Classification/Manufacturing Site...


  • Dubai, Dubai, United Arab Emirates Annora Pharma FZ LLC Full time

    Looking for Regulatory Affairs Officer with 1 to 2 years of experience in the UAE pharma industry.Nationality - Only IndiansEducational Qualification - B.Pharm/M.Pharm/D.PharmSalary: AED5, AED10,000.00 per monthExpected Start Date: 01/02/2023

  • Regulatory Affairs

    1 week ago


    Dubai, Dubai, United Arab Emirates Zahrawi Medical Full time

    About Zahrawi Group:Zahrawi Group is a leading company in the GCC Healthcare Industry with its presence in UAE, KSA, Qatar, Bahrain, & Oman markets. The company supplies and distributes high-quality products and services to Hospitals, Clinics, Laboratories, & Analytical Industries.job Brief: The incumbent is responsible for all Product...


  • Dubai, Dubai, United Arab Emirates Biogen, Inc. Full time

    The incumbent will work in close collaboration with GCC Regulatory and commercial organizations, as well as relevant local stakeholders.He/she will lead regulatory activities for the assigned portfolio to ensure submissions and approval of new marketing authorization applications (MAAs) and post-registration variations within the agreed timelines.This role...


  • Dubai, 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 DubaiResponsibilities:Responsible for coordinating and preparing CTD/eCTD submission package in accordance with regulatory requirements, and ensuring that...


  • Dubai, 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...