Current jobs related to Regulatory Affairs Consultant - Uxbridge - Parexel

  • Regulatory Affairs Expert

    2 weeks ago

    Uxbridge, United Kingdom Parexel Full time

    Unlock Your Potential as a Regulatory Affairs ExpertParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. As a recognized professional in your field of expertise, you will...

  • Regulatory Affairs Expert

    2 weeks ago

    Uxbridge, United Kingdom Parexel Full time

    Unlock Your Potential as a Regulatory Affairs ExpertParexel, a leading Clinical Research Organization (CRO), is seeking a highly qualified Principal Regulatory Affairs Consultant (Associate Director level) with expertise in Chemistry, Manufacturing, and Controls (CMC) for small molecule. As a recognized professional in your field of expertise, you will...

  • Regulatory Affairs Specialist

    2 weeks ago

    Uxbridge, United Kingdom Parexel Full time

    Regulatory Affairs Consultant - Medical Device Regulatory LeadWe are seeking a highly skilled Regulatory Affairs Consultant to lead our medical device regulatory efforts. As a key member of our team, you will be responsible for overseeing key regulatory activities and providing strategic and tactical support on combination product portfolios.Key...

  • Regulatory Affairs Specialist

    2 weeks ago

    Uxbridge, United Kingdom Parexel Full time

    Regulatory Affairs Consultant - Medical Device Regulatory LeadWe are seeking a highly skilled Regulatory Affairs Consultant to lead our medical device regulatory efforts. As a key member of our team, you will be responsible for overseeing key regulatory activities and providing strategic and tactical support on combination product portfolios.Key...

  • Regulatory Affairs Specialist

    1 hour ago

    Uxbridge, United Kingdom Park Street People Full time

    Regulatory Affairs ManagerAn innovative global pharmaceutical company is seeking a highly skilled Regulatory Affairs Manager to join their team on a 12-month temporary contract.As a key member of the regulatory team, you will provide strategic guidance and support to ensure compliance with regulatory requirements across the region.Key...

  • Regulatory Affairs Manager

    5 hours ago

    Uxbridge, United Kingdom CV-Library Full time

    An innovative global pharmaceutical company is currently looking for a Regulatory Affairs Manager with CTA, EU and early stage development experience to join their team on a 12 month temporary contract. Working with the regulatory team (and core stakeholders across multiple areas), your role will be to provide regulatory strategy and guidance across the...

  • Regulatory Affairs Manager

    2 days ago

    Uxbridge, United Kingdom Lifelancer Full time

    Senior Regulatory Affairs ManagerWe are seeking a highly experienced Senior Regulatory Affairs Manager to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory strategies.Key Responsibilities:Develop and implement...

  • Regulatory Affairs Manager

    2 days ago

    Uxbridge, United Kingdom Lifelancer Full time

    Senior Regulatory Affairs ManagerWe are seeking a highly experienced Senior Regulatory Affairs Manager to join our team at Lifelancer. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory strategies.Key Responsibilities:Develop and implement...

  • Regulatory Affairs Specialist

    2 days ago

    Uxbridge, United Kingdom Park Street People Full time

    Regulatory Affairs Manager OpportunityPark Street People Ltd is seeking a highly skilled Regulatory Affairs Manager to join their team on a 12-month temporary contract. The ideal candidate will have experience in CTA, EU, and early-stage development, with a proven track record of providing regulatory strategy and guidance across the region.Key...

  • Regulatory Affairs Specialist

    2 days ago

    Uxbridge, United Kingdom Park Street People Full time

    Regulatory Affairs Manager OpportunityPark Street People Ltd is seeking a highly skilled Regulatory Affairs Manager to join their team on a 12-month temporary contract. The ideal candidate will have experience in CTA, EU, and early-stage development, with a proven track record of providing regulatory strategy and guidance across the region.Key...

  • Regulatory Affairs Specialist

    7 days ago

    Uxbridge, United Kingdom Amgen Inc. (IR) Full time

    Senior Associate Regulatory Affairs - UK & IrelandCareer Category: RegulatorySENIOR ASSOCIATE REGULATORY AFFAIRS - UK & IRELANDWe are seeking a highly skilled Senior Associate Regulatory Affairs professional to join our team in the UK and Ireland. As a key member of our regulatory affairs team, you will play a critical role in ensuring the timely submission...

  • Regulatory Affairs Specialist

    7 days ago

    Uxbridge, United Kingdom Amgen Inc. (IR) Full time

    Senior Associate Regulatory Affairs - UK & IrelandCareer Category: RegulatorySENIOR ASSOCIATE REGULATORY AFFAIRS - UK & IRELANDWe are seeking a highly skilled Senior Associate Regulatory Affairs professional to join our team in the UK and Ireland. As a key member of our regulatory affairs team, you will play a critical role in ensuring the timely submission...

  • Regulatory Affairs Director

    6 days ago

    Uxbridge, United Kingdom Parexel Full time

    Regulatory Affairs Director OpportunityWe are seeking a highly skilled and experienced Regulatory Affairs Director to lead our team in delivering exceptional results. As a Director, you will be responsible for the successful execution of multiple projects, ensuring client satisfaction, and providing mentorship, leadership, and direction to Managers and...

  • Regulatory Affairs Director

    6 days ago

    Uxbridge, United Kingdom Parexel Full time

    Regulatory Affairs Director OpportunityWe are seeking a highly skilled and experienced Regulatory Affairs Director to lead our team in delivering exceptional results. As a Director, you will be responsible for the successful execution of multiple projects, ensuring client satisfaction, and providing mentorship, leadership, and direction to Managers and...

  • Regulatory Affairs Specialist

    5 hours ago

    Uxbridge, United Kingdom CK Group- Science, Clinical and Technical Full time

    Regulatory Affairs Manager OpportunityCK Group- Science, Clinical and Technical is seeking a highly skilled Regulatory Affairs Manager to join their team on a 12-month contract basis. The successful candidate will be based in Uxbridge and will work closely with a global pharmaceutical company.About the RoleThe Regulatory Affairs Manager will be responsible...

  • Global Regulatory Affairs Manager

    2 hours ago

    Uxbridge, United Kingdom Hays Full time

    Global Regulatory Affairs Manager - contract jobYour new company This well-known biotech is looking for an experienced Regulatory Affairs Manager to join their established Global Regulatory Affairs team. This is a 12-month contract job with scope for extension.Your new role As Global Regulatory Affairs Manager you will support the creation of strategy and...

  • Senior Regulatory Affairs Manager

    6 days ago

    Uxbridge, United Kingdom Parexel Full time

    {"title": "Senior Regulatory Affairs Manager", "content": "Regulatory Affairs Manager OpportunityWe are seeking a highly experienced Senior Regulatory Affairs Manager to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for providing strategic guidance and support to our clients in the pharmaceutical...

  • Senior Regulatory Affairs Manager

    6 days ago

    Uxbridge, United Kingdom Parexel Full time

    {"title": "Senior Regulatory Affairs Manager", "content": "Regulatory Affairs Manager OpportunityWe are seeking a highly experienced Senior Regulatory Affairs Manager to join our team at Parexel. As a key member of our regulatory affairs team, you will be responsible for providing strategic guidance and support to our clients in the pharmaceutical...

  • Regulatory Affairs Portfolio Manager

    7 days ago

    Uxbridge, United Kingdom Park Street People Full time

    Park Street People Ltd is seeking a Senior Regulatory Affairs Portfolio Manager to join their team based in the UK. This is a temporary, 8-month full-time role (35 hours per week) with flexibility to work remotely and attend key meetings on-site in Uxbridge. As a key member of the global regulatory team, you will develop and execute regulatory strategies...

  • Regulatory Affairs Portfolio Manager

    7 days ago

    Uxbridge, United Kingdom Park Street People Full time

    Park Street People Ltd is seeking a Senior Regulatory Affairs Portfolio Manager to join their team based in the UK. This is a temporary, 8-month full-time role (35 hours per week) with flexibility to work remotely and attend key meetings on-site in Uxbridge. As a key member of the global regulatory team, you will develop and execute regulatory strategies...

Regulatory Affairs Consultant

3 months ago

Uxbridge, United Kingdom Parexel Full time

When our values align, there's no limit to what we can achieve.
 

We are looking for a Consultant Regulatory Affairs for Labeling . This is a client dedicated role. The role can be based in multiple locations in UK and EU (home or office based).

In this role you will partner with Label Strategist to: Conduct international labeling operations activities to support global new product and supplemental applications to product registration, and post approval launches for impacted international markets. Collaborate with Technical Operations team members to ensure commercial distribution, Regulatory Technology for labeling submissions, PV for safety reporting, and other functional groups. Provide labeling to Advertising and Promotion for marketing pieces, and with Commercial for website postings if needed. Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking and quality control. Utilize regulatory/product knowledge to provide operational support to ensure that labeling materials meet regulatory and company requirements and timelines. You will also: Be responsible for executing and effective quality control reviews and tracking (primarily) internally used labeling documents (Core Data Sheet, Core Patient Information Leaflet, Core Instructions for Use) and outward facing local/regional labeling (USPI, Med Guide, SmPC, PIL, Canadian Product Monograph, Instructions for Use) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents. Act as operational expert for the Global Labeling tracking in RIMs, SPL generation, ensure development and maintenance of templates, collaboration features and system upgrades. Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading/editing skills and compiling supportive documentation. Support labeling inspection / audit readiness activities Skills and Experience: Bachelor’s Degree plus at least 4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Exceptional candidates with 3+ years of labeling related experience may also be considered Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging) The ability to research and create comparator labeling documents Strong understanding and past experience creating annual reports The ability to collaborate with Tech Ops for artwork implementation Proficiency in SPL (all aspects, types and troubleshooting) and the ability to manage the review and approval of labeling in a document management system. Electronic document management systems use and / or electronic submission experience Solid understanding and interpretation of US labeling regulatory requirementspreferred Solid understanding of requirements for tracking of labeling updates Solid understanding of the pharmaceutical industry drug development process and willingness to learn global labeling regulatory requirements and industry practice Solid aptitude for use of IT systems; Regulatory Information Management System (RIMS), electronic document management system (EDMS), Proficiency in MS Office suite; Willing to learn additional applications Understanding of label development and submission processes preferred. The ideal candidate should be action oriented, customer focused, ability to manage workloads and set priorities. In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams