Regulatory Affairs Manager

2 days ago

Newcastle upon Tyne, United Kingdom AstraZeneca Full time

Location – Remote, Macclesfield

Outside IR35

Duration – 6 months



Make a meaningful difference at AstraZeneca

Bring out the best in each other, and yourself, by working together as one.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.


​At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.


As a CMC Regulatory Affairs Manager, you will manage the production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges. You will manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product lifecycle including keeping business wide electronic systems up to date to maintain regulatory status.


Duties:


  • Manage the timely preparation (may include authoring) and delivery of CMC contributions to the regulatory submissions linked to medicinal products throughout the lifecycle; including clinical programs, marketing authorisation applications and all post approval approval activities
  • Accountable for delivering “submission ready” CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality.
  • Ensure that publishing tools are in place and to perform publishing of the CMC sections in a timely manner.
  • Documenting maintenance and communication of Health Authority approval status
  • Provides expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.
  • Project management expertise with the ability to adapt to changing situations to ensure on time delivery.
  • Proactively share learning from own projects with other colleagues
  • Where applicable, act as Subject Matter Expert (SME) contributing to and advising project teams.
  • Supporting the agreed strategy to employ fit for purpose content applying regulatory intelligence and to optimise proposed submission content


Minimum Requirements:

  • Degree in Chemistry, Pharmacy or Chemical Engineering, or equivalent experience
  • Fluently spoken and written English
  • Experience in CMC Regulatory Affairs within pharma industry of at least 5+ years
  • Experience in Post approval variations and MAAs is key


We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

  • Staff Regulatory Affairs Specialist

    4 days ago

    Newcastle upon Tyne, United Kingdom Leica Biosystems Full time

    Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our...

  • Staff Regulatory Affairs Specialist

    1 week ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Leica Biosystems Full time

    Leica Biosystems' mission of "Advancing Cancer Diagnostics, Improving Lives" is at the heart of our corporate culture. We're a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our associates know...

  • Regulatory Affairs Officer

    3 weeks ago

    Newcastle upon Tyne, United Kingdom Leica Biosystems Full time

    Global Regulatory Affairs Officer - Hybrid - Newcastle Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve...

  • Regulatory Affairs Team Leader

    2 weeks ago

    Newcastle upon Tyne, United Kingdom CareerBliss Full time

    Austin Vita are delighted to be offering a fully remote, permanent, job opportunity for an experienced Medical Device Regulatory Affairs professional to join a well established Regulatory Group as a Team Leader working on Class III Devices for a global manufacturer.Responsibiliites:Preparation and review of regulatory documentation and submissions for...

  • Environmental Fate Modeller

    2 weeks ago

    Newcastle upon Tyne, United Kingdom VRS Regulatory Full time

    An opportunity for an Environmental Fate Modeller / Risk Assessor to join a highly regarded team of regulatory scientists. This role would be ideal for someone with 1-2 years environmental fate experience following graduation, of possibly a recently qualified PhD researcher with a thesis closely related to environmental fate and chemical regulatory science....

  • Regulatory Affairs Officer

    3 months ago

    Newcastle upon Tyne, United Kingdom Leica Biosystems Full time

    Nearly every one of us has been impacted by cancer in some way. At Leica Biosystems, our associates know that every moment matters when it comes to cancer diagnostics. When we come to work, we’re helping to develop solutions that enable accurate diagnoses to turn anxiety into answers. When you join our global team of talented people, you’re helping make...

  • Regulatory Affairs Specialist

    3 weeks ago

    Newcastle-under-Lyme, United Kingdom Brampton Recruitment Full time

    * Relevant Life science or equivalent degree - Minimum 2 years exp within medical devices or quality environment - Experience in reviewing audit reports Our client is a global business that are specialists within its field, the company is a successful business that is currently undertaking an expansion, therefore, they are seeking an experienced Regulatory...

  • Regulatory Affairs

    1 week ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Sacco Mann Full time

    In-house Head of Regulatory Compliance (SAS Newcastle upon Tyne, England Sacco Mann is once again working with a fantastic organisation which is responsible for delivering safe, reliable electricity for more than 8 million people across 3.Reporting into the General Counsel, we are now seeking a UK qualified Solicitor to perform the role of In-house Head of...

  • Regulatory Affairs and Safety Strategy Senior

    2 months ago

    Kingston upon Hull, United Kingdom Reckitt Full time

    Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...

  • Regulatory Affairs and Safety Strategy Senior

    4 weeks ago

    Kingston upon Hull, United Kingdom Reckitt Full time

    Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...

  • Regulatory Affairs Specialist

    3 weeks ago

    Kingston upon Hull, United Kingdom Rubicon Technical Limited Full time

    Rubicon Technical is a technical service provider to the consumer healthcare industry. We work with medicines, medical devices, food supplements, cosmetics, and functional foods, providing expertise in regulatory affairs, medical affairs, development and formulation, clinical nutrition, pharmacology, trade marking, quality management, project management and...

  • Regulatory Affairs and Safety Senior Associate

    1 week ago

    Kingston upon Hull, United Kingdom Reckitt Full time

    Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a...

  • Corporate Affairs Intern

    2 months ago

    Newcastle upon Tyne, United Kingdom Sage Group PLC Full time

    Make your degree stand out with an experience like no other. Have you got a passion for Corporate Affairs and are looking for an internship with a top employer? Join Sage as a Corporate Affairs Intern and gain practical, valuable skills from a global, FTSE 100 company and unleash your potential. Sage exists to knock down barriers so everyone can thrive,...

  • Regulatory Affairs and Safety Senior Associate, Gastrointestinal

    3 days ago

    Kingston upon Hull, United Kingdom Reckitt Full time

    We are Reckitt Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a...

  • Corporate Affairs Intern

    1 week ago

    Newcastle upon Tyne, Newcastle upon Tyne, United Kingdom Sage Group PLC Full time

    Make your degree stand out with an experience like no other.Have you got a passion for Corporate Affairs and are looking for an internship with a top employer? Join Sage as a Corporate Affairs Intern and gain practical, valuable skills from a global, FTSE 100 company and unleash your potential.Sage exists to knock down barriers so everyone can thrive,...

  • Chemistry Graduate

    2 months ago

    Newcastle Upon Tyne, United Kingdom VRS Recruitment Full time

    Do you like Chemistry and IT? - Have you recently graduated and are looking for a non-lab role? - Do you enjoy using your communications skills? - Do you enjoy travelling with work? - Would you like to work for a world leading chemical software company? If so, this could be the role for you. **The company**: An exciting opportunity to work for a market...

  • Spectrum and Regulatory Affairs Expert

    1 week ago

    Staines-upon-Thames, United Kingdom Samsung Electronics Full time

    Position Summary We currently have an opportunity for a Spectrum and Regulatory Affairs Expert to join us here at Samsung Research UK. Working as a member of the Standards & Spectrum Group, the job's main purpose is to provide expert support to Samsung spectrum strategy and telecoms technology development. As part of the global Samsung Spectrum team, the...

  • Ra Officer

    4 weeks ago

    Newcastle upon Tyne, United Kingdom Leica Biosystems Full time

    Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our...

  • Ra Officer

    4 weeks ago

    Newcastle upon Tyne, United Kingdom Leica Biosystems Full time

    Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. Our...

  • QA Officer

    2 weeks ago

    Newcastle upon Tyne, United Kingdom Immunodiagnostics System Ltd Full time

    **QA Officer**: **QA/RA - UK**: Department: QA/RA Type: Permanent Based: Hybrid **Salary**: Closing Date: 20/05/2024 IDS is a leading in-vitro diagnostic solution provider to the clinical laboratory market. We develop, manufacture and market innovative immunoassays and automated immunoanalyser technologies to provide improved diagnostic outcomes for...