Regulatory Affairs Officer
3 days ago
Background
Neon Healthcare (“Neon”) is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant operations in the UK and is looking to expand its activities into other international markets.
Reporting to the Senior Regulatory Affairs Officer, this role supports the Regulatory team with post-approval activities for the product portfolio.
Description of Main Duties and Responsibilities
·Life-cycle maintenance of all aspects of the MAs registered particulars.
·Assist with the creation, collation and publication of all required documentation for the CTD dossier.
·Implementation and communication of MA changes across stakeholder groups. Ensuring all compliance activities are correctly managed.
·Work closely with in-house, 3rd party designers and contract sites for packaging artwork development and updates.
·Generation and maintenance of patient information leaflets and packaging components, including artwork management, and ensure regulatory compliance with legislation and company approval systems.
·Perform product information and CMC compliance activities for the entire product life cycle.
·Developing and maintaining a sound knowledge of European and UK regulatory legislation and guidelines to provide advice and expertise internally for matters related to our products.
·Communicating with other departments, clients and regulatory authorities.
·Maintain regulatory files/database and chronologies in good order. Maintain system for tracking changes in documents submitted to agencies or partners.
·Work collaboratively across organisation.
·Ensure compliance with company policies, procedures and training expectations.
·Perform other appropriate duties, where necessary.
·Provide support during New Product Development and Lifecycle Management projects.
·Define, gather and assemble information needed for submissions according to applicable regulations and relevant guidelines.
·Lead and/or support the submission of licenses and authorisations for new products and changes to existing products.
·Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries ensuring timely approvals.
·Provide Regulatory Affairs support during internal and external audits.
·Assists in the development of standard process for Regulatory Affairs processes and systems.
Knowledge / Skills / Attributes
- A minimum of a Bachelor’s degree is required. A concentration in science, engineering, medical/scientific writing, public health administration is preferred.
- Minimum 2 years of working experience within Regulatory Affairs or equivalent.
- Experience preparing technical documentation for submission to regulatory agencies
- Excellent verbal and written communication and interactive skills.
- Work on own initiative and take responsibility for managing the day to day regulatory activities for a portfolio of products.
- Work effectively within the Regulatory Affairs team and with other stakeholders to deliver on Company Objectives and Goals.
- Able to multitask and manage conflicting priorities with sound time-management skills.
- Able to demonstrate a genuine interest and knowledge of the regulatory environment and a desire to succeed in a regulatory affairs role in the pharmaceutical industry.
- Ability to identify compliance risks and escalate when necessary
-
R&D Regulatory Specialist
3 days ago
Ware, UK, Hertfordshire, United Kingdom Farecla Products Limited Part timeRegulatory affairs, safety data sheets, compliance, labelling; You know these like the back of your hand! You have years of experience in these areas and have the ability to work autonomously, using your initiative, and enjoying a certain level of responsibility. How about working in the on-site R&D lab, hands on with the products, on top of this?At Farécla...
-
Principal/Senior Consultant
1 week ago
Bishop's Stortford, UK, Hertfordshire, United Kingdom Scendea Full timeThe RoleScendea is seeking a highly motivated individual to join our global team as a full-time Principal Consultant/Senior Consultant (CMC). This is a hybrid position, affiliated to our UK Bishop's Stortford office, with a requirement to work in the office a minimum of one day per month.This is an excellent opportunity to progress your career at a...
-
Head of College
2 months ago
Stevenage, UK, Hertfordshire, United Kingdom Engineering Institute of Technology Part timeThe Engineering College of Technology (ECT) is thrilled to announce the expansion of our team with a new position: Head of College (Operations).ECT has recently been established and registered in the UK, and is a sister company of our Australian-based operation, the Engineering Institute of Technology (EIT). EIT is one of the only institutes in the world...
-
Head of Clinical
1 month ago
Bishop's Stortford, UK, Hertfordshire, United Kingdom Scendea Full timeThe RoleScendea is seeking a highly motivated individual to join our global team as a full-time Head of Clinical and Principal Consultant. This is a hybrid position, affiliated to our Bishop’s Stortford office, UK, with a requirement to work in the office a minimum of one day per month. The position reports into the Head of Product Development and...
-
Full time Office Administrator
4 weeks ago
Bishop's Stortford, UK, Hertfordshire, United Kingdom Scendea Full timeThe Role Scendea are currently expanding our business support function and are seeking an Office Administrator to join our UK team on a full-time basis working at our Bishop’s Stortford Office, Mon-Fri (40 hours) normal office hours. This role reports to the Business Support Administrator within the Business Support Team.The successful candidate will be a...
-
Pharmaceutical Quality Head
3 weeks ago
Welwyn, UK, Hertfordshire, United Kingdom NOVUMGEN Full timeNovumgen – the group of Entrepreneurs and Scientists.Novumgen is a diverse, integrated specialty pharmaceutical and biological company focused on investing, developing, manufacturing, and supplying innovative products that provide benefits to patients and prescribers. We are focused on delivering life-changing medicines that contribute safety and value to...
-
Head of Quality
1 month ago
Welwyn Garden City, UK, Hertfordshire, United Kingdom NOVUMGEN Full timeJob SummaryThe Head of Quality is a pivotal leadership position tasked with upholding the highest standards of quality and compliance throughout the organization’s operations. Reporting to senior management, this role involves overseeing the creation, implementation, and maintenance of robust quality management systems to ensure regulatory compliance,...
-
Assistant General Counsel
1 week ago
Stevenage, UK, Hertfordshire, United Kingdom Spur Therapeutics Full timeWhy Spur?Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of...
-
Technical Operations Lead
1 week ago
Watford, UK, Hertfordshire, United Kingdom Corona Energy Full timeJoin our dynamic team as an Operations Technical Lead and be at the forefront of supporting the growth of our organisation! As a key player, you'll collaborate closely with our regulatory policy team, ensuring that we stay ahead of the curve by monitoring and incorporating any regulatory changes affecting our operations.The ideal candidate should have a...
-
General Manager
3 weeks ago
Hatfield, UK, Hertfordshire, United Kingdom McCarthy Recruitment Full timeJob Title: General ManagerLocation: HatfieldSalary: £60,000 to £70,000 per annum, plus car allowance, 10% bonusRole: Full-TimeAre you an experienced Manufacturing Site Manager looking for an opportunity to join a growing, established business?Our client is a leading manufacturer producing some of the UK’s leading brands. Known not only for its dedication...
-
Clinical Operations Lead
1 week ago
Welwyn Garden City, UK, Hertfordshire, United Kingdom Adecco Full timeJob Title: Clinical Operations LeadDuration: 6 months with scope to extend Location: Welwyn Garden City – 2 days in officeJoin us as a Contract Clinical Operations Lead and be part of our client's bold vision to deliver 20 transformative medicines addressing diseases with the highest societal burden.Our client, a pioneer in healthcare, has been...
-
Sales Progressor
3 weeks ago
St Albans, UK, Hertfordshire, United Kingdom Crest Nicholson plc Full timeCrest Nicholson has been building new homes for 60 years and is firmly established as a leading developer with a passion for not just building homes, but creating vibrant sustainable communities.Due to continued growth here at Crest Nicholson. Our Chiltern division have an exciting opportunity for an experienced Sales Progressor to join the team. You will...
-
Manufacturing Manager
3 weeks ago
Hatfield, UK, Hertfordshire, United Kingdom Cpl Life Sciences Full timeManufacturing Managers with a background in Solid Dose Pharmaceuticals I want to speak to you about a very exciting opportunity to join a client who are looking to expand and streamline their manufacturing facility. This role has the responsibility to lead and manage the manufacturing operation and to co-ordinate production resources, at their Production...
-
Specialist – Regulatory Affairs PPP
3 days ago
UK, UK, United Kingdom VRS Regulatory Full timeAn opportunity to join the Regulatory Affairs team at an R&D focussed global PPP company. You will:Manage a portfolio of plant protection products in specific geographical territoriesDevelop regulatory strategy Become the subject matter expert on the regulations/guidelines in your territory. As a regulatory Specialist, you will develop regulatory strategy...
-
Regulatory Support Officer
2 months ago
UK, UK, United Kingdom VRS Regulatory Full timeA rare opportunity for an aspiring regulatory affairs officer to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive training. An excellent opportunity to start and establish your career in...
-
Regulatory Affairs Officer
5 months ago
Hertford, United Kingdom Neon Healthcare Full timeJob description **Background** Neon Healthcare (“Neon”) is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant...
-
Regulatory Affairs Officer
2 weeks ago
Hertford, United Kingdom NEON HEALTHCARE LTD Full timeBackgroundNeon Healthcare (“Neon”) is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant operations in the UK and is...
-
Regulatory Affairs Officer
1 week ago
Hertford, United Kingdom NEON HEALTHCARE LTD Full timeBackgroundNeon Healthcare (“Neon”) is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant operations in the UK and is...
-
Regulatory Affairs Officer
3 days ago
Hertford, United Kingdom NEON HEALTHCARE LTD Full timeBackgroundNeon Healthcare (“Neon”) is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription only medicines to hospitals, wholesalers, and retail pharmacies. Founded by entrepreneurs with a successful track in building pharmaceutical businesses, the company has significant operations in the UK and is...
-
UK, UK, United Kingdom VRS Regulatory Full timeExciting opportunity to join the regulatory affairs team at an established and highly reputable chemical regulatory science consultancy. This is expansion to cover an increasing workload. The role is delivery focussed with no commercial or business development aspects. We are looking for a regulatory person for a purely regulatory delivery role. This role...
-
Senior Product Regulatory Affairs Leader
3 days ago
Middlesbrough, UK, North Yorkshire, United Kingdom VRS Regulatory Full timeA rare opportunity to take a Senior Management role and head up a global chemical product regulatory affairs team at a global chemical manufacturing business. We are looking for a commercially and strategically minded leader who has a passion for regulation and legislation governing chemical products.You remit is to create and drive the strategy for product...
-
Regulatory Affairs Manager
3 days ago
Hertford, United Kingdom NEON HEALTHCARE LTD Full timeJob Title: Regulatory Affairs OfficerAbout the Role:We are seeking a highly motivated Regulatory Affairs Officer to join our team at Neon Healthcare Ltd. As a key member of our Regulatory Affairs team, you will be responsible for supporting the post-approval activities for our product portfolio.Main Responsibilities:Maintain the life-cycle of all aspects of...
-
Regulatory Affairs Specialist
2 days ago
Hertford, United Kingdom NEON HEALTHCARE LTD Full timeAbout this roleNeon Healthcare Ltd is an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription-only medicines to hospitals, wholesalers, and retail pharmacies. Reporting to the Senior Regulatory Affairs Officer, this role supports the Regulatory team with post-approval activities for the product...
-
Regulatory Affairs
2 months ago
Huddersfield, UK, West Yorkshire, United Kingdom LFH Regulatory Limited Part timeAre you an experienced regulatory affairs and quality assurance professional looking for a new challenge? If so, we have just the opportunity for you!LFH is a top medical device consultancy company that is seeking a permanent Regulatory Affairs & Quality Assurance Consultant. We are open to full time as well as part time applicants between 3 to 5 days. What...
-
Chemical Regulatory Data Specialist
3 days ago
Harlow, UK, Essex, United Kingdom VRS Regulatory Full timeWe are looking for a regulatory officer with knowledge of substance or mixture classification and SDS/label authoring experience. Role is in a large product stewardship department at a UK based global speciality chemicals business.The role will entail:Management of raw material dataValidation of classifications, SDS and labelsLiaison with suppliers to...
-
Regulatory Affairs Manager
2 months ago
UK, UK, United Kingdom Actalent Full timeRegulatory Affairs Manager (UK & Ireland)As the Regulatory Affairs Manager for the UK and Ireland, you will report directly to the UK Country Manager. You will provide expert regulatory guidance to our UK organization and manage all regulatory activities across the UK and Ireland. Additionally, you will serve as the Local Person for Pharmacovigilance (LPPV)...
-
Regulatory Affairs Manager
1 month ago
UK, UK, United Kingdom Park Street People Full timeAn 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 Consultant
3 weeks ago
UK, UK, United Kingdom eTeam Full timeRole: EMEA Regulatory Affairs ConsultantDuration: 5 MonthsLocation: High Wycombe, UK - Hybrid working (2 /3 days in High Wycombe office)KEY RESPONSIBILITIESManagement of post-approval activities for specified OTC products• Supports the EMEA Regulatory Affairs team for post-approval activities for MRP/DCP products across EEA and coordinate worksharing (WS)...
-
Regulatory Affairs Manager
3 weeks ago
UK, UK, United Kingdom LanceSoft, Inc. Full timeTitle: Regulatory Affairs ManagerDuration: Till March 2024Location: Hybrid. 1 - 2 days in the office per week at High Wycombe HP12 4PTNotes: Inside IR35 - till March 2024 initially - OTC experience is essential.Job Description:EMEA REGULATORY AFFAIRS –REGULATORY CONSULTANTKEY RESPONSIBILITIESManagement of post-approval activities for specified OTC...
-
Regulatory Affairs Associate
2 months ago
UK, UK, United Kingdom Cure Talent Full timeCure Talent is thrilled to partner with a leading Medical Devices Manufacturer, who due to continued growth, has an exciting opportunity for an experienced Regulatory Affairs Associate to join their team.As the new Regulatory Affairs Associate, you will be responsible for supporting global product registrations, maintaining design dossiers, and ensuring...
-
Regulatory Affairs Manager
3 days ago
Slough, UK, Berkshire, United Kingdom Blackfield Associates Full timeBlackfield Associates are partnered with a Pharmaceutical client, seeking a Regulatory Affairs Manager to lead their regulatory activities for both developmental and post-approval projects for a speciality and Generic drug portfolio.As Regulatory Affairs Manager, you will: Ensure timely preparation and submission of documents required by the EMA for an EU...
-
Head of Regulatory Affairs
3 days ago
Greater Manchester, UK, Greater Manchester, United Kingdom Radar Recruitment Full timeWe are supporting a Pharmaceutical business as they seek to bring on board a new Head of Regulatory Affairs to join them at an exciting phase of growth.About the business:This organisation is well established, have a diverse customer base and are well geared for growth in the coming years. The business supply a range of pharmaceutical products into multiple...
-
Regulatory Affairs Manager
3 weeks ago
UK, UK, United Kingdom CK Group Full timeCK Group are recruiting for a Regulatory Affairs Manager, to join a company in the Pharmaceutical industry, at their site based in High Wycombe, on a contract basis to the end of March 2025.Salary: Hourly £61.00 per hour PAYE or £82.00 per hour Umbrella.Regulatory Affairs Manager Role:Management of post-approval activities for specified OTC...