Regulatory Affairs Specialist

4 weeks ago

London, United Kingdom AstraZeneca GmbH Full time

Regulatory Affairs Specialist – CVRM

Location: London

Competitive Salary and Benefits

Closing date: 5th May 2024

Introduction to Role:

Join our CVRM Regulatory Team as a Regulatory Affairs Specialist and embrace the opportunity to shape the future of healthcare. Be part of changing the practice of medicine forever. In this role, you will deliver and maintain competitive licenses for UK commercial brands, ensuring regulatory compliance for defined product and project responsibilities, including project leadership. You will also be responsible for the timely delivery of clinical trial approvals and maintaining high regulatory compliance standards for the UK.

Accountabilities:

As a Regulatory Affairs Specialist, you will ensure timely submission and approvals of all licensing applications and compliance with UK regulatory requirements. You will provide regulatory input to stock and supply issues, manage pack changes, ensure labelling compliance, and develop professional working relationships with assessors and administrative staff within the regulatory agencies. You will also prepare high-quality regulatory applications and responses for the UK, defend existing labelling, and contribute to cross-functional team working within the Medical & Regulatory Department and other areas of the business.

As a Regulatory Specialist you will also manage the CVRM team finance activities e.g. tracking invoices, making payments etc in addition to other organisational tasks that support the wider team.

You will be reporting to the Regulatory Affairs TA lead and work in close collaboration with Regulatory Managers and Specialists within CVRM and across different TAs.

Essential Skills/Experience:

  • UK Regulatory experience
  • Ability to work independently on regulatory submissions and approvals throughout the product lifecycle in a timely manner
  • Drive meaningful interactions with cross-functional teams within the UKMC as well as the Global team
  • Demonstrable negotiation skills
  • Good understanding of drug development processes
  • Ability to make optimal use of IT systems

Desirable Skills/Experience:

  • Experience with compliance systems
  • Initiative to contribute to the optimisation and continuous improvement of current ways of working

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

If you are inspired by the possibilities of science to make a difference and ready to discover what you can do by joining us on this exciting journey and believe you can contribute to this bold ambition – join us

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

Follow AstraZeneca on Facebook

Follow AstraZeneca on Instagram

#J-18808-Ljbffr

  • Regulatory Affair Specialist

    1 month ago

    South West London, United Kingdom Harrington Recruitment Ltd Full time

    **The Role** The Regulatory Affairs Specialist will report to the Commercial Director. This is expected to be a hybrid role, 3 days per week working from home and 2 days based South-West London. The person should be located a commutable distance to the office.. Working together with colleagues in Germany, the Regulatory Affairs Specialist will be required...

  • Regulatory Affairs Specialist

    4 weeks ago

    London, United Kingdom AstraZeneca Full time

    Regulatory Affairs Specialist – CVRM Location: London Competitive Salary and Benefits Closing date: 5th May 2024 Introduction to Role: Join our CVRM Regulatory Team as a Regulatory Affairs Specialist and embrace the opportunity to shape the future of healthcare. Be part of changing the practice of medicine forever. In this role, you...

  • Regulatory Affairs Specialist

    1 week ago

    London, United Kingdom Meet Full time

    I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with all relevant regulations and standards in various...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, United Kingdom Meet Full time

    I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with all relevant regulations and standards in various...

  • Regulatory Affairs Specialist

    1 week ago

    London, United Kingdom Meet Full time

    Job DescriptionI am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with all relevant regulations and standards in...

  • Regulatory Affairs Specialist

    2 days ago

    London, United Kingdom Meet Full time

    I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with all relevant regulations and standards in various...

  • Regulatory Affairs Specialist

    4 days ago

    London, United Kingdom Meet Full time

    Job Description I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with all relevant regulations and standards...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, United Kingdom Meet Full time

    I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with all relevant regulations and standards in various...

  • Sds Author

    1 month ago

    London, United Kingdom VRS Regulatory Full time

    We are looking for a Safety Data Sheet / SDS Author / Regulatory Officer for a London based consumer products company. Your role will be varied and include researching pending changes developments to global chemical regulations, developing regulatory documents (SDSs, labels etc) for new and existing products, and providing regulatory support to internal...

  • Regulatory Affairs Specialist

    1 week ago

    London Area, United Kingdom Meet Full time

    I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with all relevant regulations and standards in various...

  • Regulatory Affairs Specialist

    2 weeks ago

    London Area, United Kingdom Meet Full time

    I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with all relevant regulations and standards in various...

  • Regulatory Affairs Specialist

    1 week ago

    London Area, United Kingdom Meet Full time

    I am seeking a highly motivated and experienced Regulatory Affairs Specialist with expertise within OTC/Cosmetics experience to join us on a contracted basis for a period of 6 to 12 months. As a key member of the Regulatory Affairs team, you will play a crucial role in ensuring our products comply with all relevant regulations and standards in various...

  • Regulatory Affairs Specialist

    1 month ago

    London, United Kingdom AstraZeneca Full time

    **Regulatory Affairs Specialist** **Location: Pancras Square** **Competitive Salary & Benefits** **Advert Closing Date: 24/02/23** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines for some of the world’s most serious diseases. But...

  • Regulatory Affairs Specialist

    2 weeks ago

    Wembley, Greater London, United Kingdom Medicareplus International Ltd Full time

    Job Summary RA Specialist is responsible for ensuring continued compliance of the Quality Management System of the company with the relevant Medical Device Regulations, International Standards, and Customer Requirements and that this is maintained and implemented accordingly. Responsible for maintaining and supporting the promotion of regulatory affairs...

  • Regulatory Affairs Specialist

    2 weeks ago

    Wembley, Greater London, United Kingdom Medicareplus International Ltd Full time

    Job Summary RA Specialist is responsible for ensuring continued compliance of the Quality Management System of the company with the relevant Medical Device Regulations, International Standards, and Customer Requirements and that this is maintained and implemented accordingly. Responsible for maintaining and supporting the promotion of regulatory affairs...

  • Regulatory Affairs Specialist

    4 days ago

    Wembley, Greater London, United Kingdom Medicareplus International Ltd Full time

    RA Specialist is responsible for ensuring continued compliance of the Quality Management System of the company with the relevant Medical Device Regulations, International Standards, and Customer Requirements and that this is maintained and implemented accordingly. Responsible for maintaining and supporting the promotion of regulatory affairs and ensuring...

  • Regulatory Affair Specialist

    2 weeks ago

    Wembley, Greater London, United Kingdom Medicareplus International Ltd Full time

    Job Summary RA Specialist is responsible for ensuring continued compliance of the Quality Management System of the company with the relevant Medical Device Regulations, International Standards, and Customer Requirements and that this is maintained and implemented accordingly. Responsibilities · Responsible for maintaining and supporting the promotion of...

  • Regulatory Affair Specialist

    2 weeks ago

    Wembley, Greater London, United Kingdom Medicareplus International Ltd Full time

    Job Summary RA Specialist is responsible for ensuring continued compliance of the Quality Management System of the company with the relevant Medical Device Regulations, International Standards, and Customer Requirements and that this is maintained and implemented accordingly. Responsibilities · Responsible for maintaining and supporting the promotion of...

  • Regulatory Affair Specialist

    4 days ago

    Wembley, Greater London, United Kingdom Medicareplus International Ltd Full time

    Job Description Job Summary RA Specialist is responsible for ensuring continued compliance of the Quality Management System of the company with the relevant Medical Device Regulations, International Standards, and Customer Requirements and that this is maintained and implemented accordingly. Responsibilities · Responsible for maintaining and supporting...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, United Kingdom Meet Full time

    Job Title: Regulatory Affairs Specialist - Medical Device Location: Fully remoteCompany Description:We are a leading healthcare company dedicated to improving patient outcomes through innovative medical technologies.Our commitment to quality and compliance drives us to seek talented professionals to join our Regulatory Affairs team.Position Overview:As a...