Regulatory Affairs Consultant

1 month ago

London, United Kingdom Clinical Professionals Limited Full time

Senior Regulatory Affairs Labelling Consultant
Job Type: Permanent
Job Title: Senior Regulatory Labelling Consultant (Labelling Strategy)
Location: UK and Europe – Fully Remote
Salary: Competitive Salary + Excellent Benefits
Employee Type: Permanent
You will work as a regulatory affairs labelling lead for developing and establishing drug programs and be accountable for driving global labelling strategy. This is a challenging opportunity to demonstrate your knowledge in managing regulatory processes and supporting cross-functional teams with labelling compliance.
This role can be based in the UK or Europe and offers the right candidate a chance to take the lead on regulatory labelling processes. 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.
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 (EU SmPC, EU PIL, etc) as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling, labels and supportive documents.
· 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
University Degree in a scientific degree
~4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
~ Regulatory Information Management System (RIMS), electronic document management system (EDMS). In addition, he/she should be capable of dealing with ambiguity, be creative, be comfortable working with multifunctional teams
~ Fluent in English written and spoken

  • Regulatory Affairs Consultant

    1 month ago

    London, United Kingdom Brightwork Ltd Full time

    BaxMed – Ad-Hoc Senior Regulatory Affairs Consultant Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment...

  • Regulatory Affairs Consultant

    4 weeks ago

    City of London, United Kingdom Hays Full time

    Regulatory Affairs Consultant CMC, biologics outside of IR35Your new companyThis growing US rare disease company is looking for an experienced Regulatory Affairs CMC (biologics) professional to join them on a 12-month contract, this contract job is outside of IR35 and can be fully remote or hybrid working.Your new roleAs Regulatory Affairs Consultant CMC,...

  • Ad-Hoc Senior Regulatory Affairs Consultant

    1 month ago

    London, United Kingdom Brightwork Ltd Full time

    BaxMed – Ad-Hoc Senior Regulatory Affairs Consultant Led by Stuart Baxter, a seasoned professional with a distinguished career in Regulatory Affairs, BaxMed Regulatory Ltd is an exciting early-stage organisation formed to provide Regulatory and Quality Compliance Services for the global Medical Device / healthcare sector. With a core ethos and commitment...

  • Regulatory affairs senior

    3 weeks ago

    London, United Kingdom Compliance Professionals Full time

    Our client is a successful banking firm with a strong global presence, offering a comprehensive range of services across corporate and investment banking activities. Act as a subject matter expert in Regulatory Affairs. Maintain an effective, professional and proactive relationship with UK regulators and assist the Local Compliance Officers in dealing...

  • 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 Manager

    2 weeks ago

    London, United Kingdom Allen Recruitment Consulting Full time

    Are you an experienced Regulatory Affairs professional with a background in Chemistry, Manufacturing and Controls and experience working in the Biopharmaceutical/Biotechnology industry, and are you looking for a new opportunity? We have your next role, we are recruiting for a Regulatory Affairs CMC Manager with Post Approval Submissions and who has...

  • 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 Officer

    2 weeks ago

    London, United Kingdom Black Swan Group Full time

    Exciting Opportunity for Regulatory Affairs AVP: Are you a regulatory compliance expert seeking your next career move? My client are a Global banking organisation on the lookout for a talented individual to join our team as a Regulatory Affairs Assistant Vice President (AVP). Key Responsibilities: Develop and maintain relationships with UK regulators,...

  • Regulatory Affairs Officer

    2 weeks ago

    London, United Kingdom Black Swan Group Full time

    Exciting Opportunity for Regulatory Affairs AVP: Are you a regulatory compliance expert seeking your next career move? My client are a Global banking organisation on the lookout for a talented individual to join our team as a Regulatory Affairs Assistant Vice President (AVP). Key Responsibilities: Develop and maintain relationships with UK regulators,...

  • 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

    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 Manager

    2 weeks ago

    Uxbridge, Greater London, United Kingdom Park Street People 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 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

    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...

  • 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 Officer

    2 weeks ago

    London, United Kingdom Black Swan Group Full time

    Job DescriptionExciting Opportunity for Regulatory Affairs AVP:Are you a regulatory compliance expert seeking your next career move? My client are a Global banking organisation on the lookout for a talented individual to join our team as a Regulatory Affairs Assistant Vice President (AVP).Key Responsibilities:Develop and maintain relationships with UK...

  • Regulatory Affairs Manager

    2 days ago

    London, United Kingdom in Newbury Full time

    Home Cmc Regulatory Affairs Manager (Individual Con... 1 Cmc regulatory affairs manager (individual contributor) jobs in Brentford CMC Regulatory Affairs Manager (Individual Contributor) Brentford, London GlaxoSmithKline Inc. 11.05.2024 CMC Regulatory Affairs Manager (Individual Contributor) Brentford, London GlaxoSmithKline Inc. 11.05.2024 ...

  • 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...