Regulatory Affairs Specialist for Pharmaceutical Product Compliance
6 days ago
Job Overview
NEON HEALTHCARE LTD seeks a highly skilled Regulatory Affairs Specialist to support the post-approval activities for its product portfolio.
About NEON HEALTHCARE LTD
We are an ambitious and fast-growing pharmaceutical company that develops, produces, markets, and sells prescription-only medicines to hospitals, wholesalers, and retail pharmacies. With significant operations in the UK, we aim to expand our activities into other international markets.
Responsibilities
The successful candidate will:
- Implement and communicate 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.
- Generate and maintain patient information leaflets and packaging components, ensuring regulatory compliance with legislation and company approval systems.
- Perform product information and CMC compliance activities for the entire product life cycle.
- Develop and maintain a sound knowledge of European and UK regulatory legislation and guidelines to provide advice and expertise internally.
- Communicate with other departments, clients, and regulatory authorities.
- Maintain regulatory files/database and chronologies in good order.
- Ensure compliance with company policies, procedures, and training expectations.
- Provide support during New Product Development and Lifecycle Management projects.
- Prepare responses to regulatory agencies' questions and other correspondence to resolve post-submission queries.
- Provide Regulatory Affairs support during internal and external audits.
- Assist in the development of standard processes for Regulatory Affairs processes and systems.
Requirements
The ideal candidate should possess:
- A minimum of a Bachelor's degree, preferably in science, engineering, medical/scientific writing, or public health administration.
- 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.
- Ability to work on own initiative and take responsibility for managing day-to-day regulatory activities for a portfolio of products.
- 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.
Estimated Salary: £45,000 - £60,000 per annum
-
Pharmaceutical Regulatory Affairs Specialist
4 weeks ago
Watford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full timeJob DescriptionBackgroundAt Neon Healthcare, we are committed to developing and marketing innovative prescription only medicines to hospitals, wholesalers, and retail pharmacies. As a fast-growing pharmaceutical company, we are seeking a Regulatory Affairs Specialist to join our team and support the post-approval activities for our product portfolio.Key...
-
Regulatory Affairs Specialist
4 weeks ago
Watford, Hertfordshire, United Kingdom NEON HEALTHCARE LTD Full timeJob Title: Regulatory Affairs OfficerDescription:At Neon Healthcare Ltd, we are seeking a highly skilled Regulatory Affairs Officer to join our team. As a key member of our Regulatory Affairs team, you will be responsible for supporting post-approval activities for our product portfolio.Main Duties and Responsibilities:Life-cycle maintenance of all aspects...
-
Regulatory Affairs Coordinator
1 week ago
Watford, Hertfordshire, United Kingdom Allwyn UK Full timeAbout Allwyn UKWe are a multi-national lottery operator with a market-leading presence in several countries, and we have been awarded the Fourth Licence to operate the National Lottery in the UK. Our aim is to create one of the UK's most inclusive organisations where people can bring their best selves to work every day for the benefit of good causes.At...
-
Senior Pharmaceutical Compliance Specialist
3 days ago
Watford, Hertfordshire, United Kingdom Macstaff Full timeMacstaff, a global pharmaceutical distribution firm, is seeking an experienced Quality Assurance Manager to lead their team at the Elstree Hertfordshire Head Office.The successful candidate will have a strong background in QA within a GDP environment and experience in supervisory management. They will also be proficient in MS Office and possess excellent...
-
Regulatory Compliance Specialist
7 days ago
Watford, Hertfordshire, United Kingdom Allwyn UK Full timeAbout the RoleWe are seeking a skilled Regulatory Compliance Specialist to join our team at Allwyn UK. As a key member of our Governance Assurance function, you will play a critical role in ensuring that we meet our regulatory obligations and maintain a culture of compliance throughout the organization.Key ResponsibilitiesAnalyze data and reports to identify...
-
Financial Regulatory Compliance Manager
1 day ago
Watford, Hertfordshire, United Kingdom CV-Library Full timeJob Description:Devonshire Hayes Recruitment Specialists Ltd is seeking an experienced Financial Regulatory Compliance Manager to join their team. The successful candidate will be responsible for managing financial regulatory compliance, including risk management, internal audits, and non-financial reporting.Key Responsibilities:To manage financial...
-
Pharmaceutical Care Specialist
3 weeks ago
Watford, Hertfordshire, United Kingdom Day Webster Full timeRole OverviewWe are seeking a skilled Pharmaceutical Care Specialist to join our team at Day Webster. The successful candidate will be responsible for providing pharmaceutical care to patients, collaborating with healthcare professionals, and ensuring safe and effective medication management.Key Responsibilities:- Provide pharmaceutical care to patients-...
-
Regulatory Compliance Officer
15 hours ago
Watford, Hertfordshire, United Kingdom ENGINEERINGUK Full timeJob OverviewENGINEERINGUK is seeking a highly skilled Compliance Enhancement Coordinator to join our team. This role will play a key part in ensuring our regulatory compliance and enhancing our assurance framework.About UsAs a leading provider of lottery services, we are committed to creating a new experience for the National Lottery. Our aim is to power...
-
Watford, Hertfordshire, United Kingdom Barrington James Full timeBarrington James is seeking a skilled Quality Assurance Specialist to join our team in Watford, UK. This role will play a crucial part in ensuring the production of vaccines adheres to rigorous regulatory and quality standards.Job DescriptionThis is a full-time position that involves overseeing sterility assurance, reviewing batch records, conducting audits,...
-
Quality Assurance Manager
1 month ago
Watford, Hertfordshire, United Kingdom Macstaff Full timeAs a Quality Assurance Manager, you will be responsible for ensuring the company's pharmaceutical products comply with GDP regulations. This involves managing risk assessments, change control, deviations, root cause analysis, and customer complaints. You will also lead and support a small QA team and assist the Responsible Person in ensuring compliance with...
-
Senior Medical Advisor Role
6 days ago
Watford, Hertfordshire, United Kingdom Lundbeck Full timeWe are excited to announce an exceptional opportunity for a Senior Medical Advisor to join our team at Lundbeck UK & Ireland. As a key member of our Medical Affairs department, you will contribute to the development and implementation of medical strategies that address the complex needs of patients living with brain diseases.With a strong track record of...
-
Evidence Analysis Specialist
1 month ago
Watford, Hertfordshire, United Kingdom Smith+Nephew Full timeUnlock the Power of Evidence-Based Decision MakingAt Smith+Nephew, we're committed to delivering innovative solutions that empower better decisions and impactful clinical messaging. As an Evidence Analysis Specialist, you'll play a critical role in supporting our Evidence Analysis team in delivering their purpose.Key Responsibilities:Coordinate and...
-
Compliance and Risk Control Specialist
1 day ago
Watford, Hertfordshire, United Kingdom CV-Library Full timeJob Summary:Devonshire Hayes Recruitment Specialists Ltd is recruiting a Compliance and Risk Control Specialist to oversee the implementation of effective risk management and compliance strategies. The successful candidate will be responsible for identifying and mitigating risks, ensuring compliance with regulatory requirements, and maintaining accurate...
-
Medical Director UK
6 days ago
Watford, Hertfordshire, United Kingdom Lundbeck Full timeLundbeck is a pioneering pharmaceutical company dedicated to improving the lives of people affected by brain diseases. As a Medical Manager, you will play a vital role in advancing our mission to transform brain health and improve patient outcomes.The successful candidate will be a GMC Registered Physician or GPHC registered Pharmacist with established UK...
-
Taxation Compliance Specialist
6 days ago
Watford, Hertfordshire, United Kingdom Carlton Recruitment Full timeJob DescriptionWe are seeking a Senior Corporate Tax Professional to join our team in Watford. As a key member of the Business Tax Team, you will be responsible for managing the compliance affairs of a wide-ranging portfolio of corporate and personal clients.Key Responsibilities:Carrying out tax work in accordance with the Firm's procedures.Preparation of...
-
Clinical Evidence Specialist
4 weeks ago
Watford, Hertfordshire, United Kingdom Smith+Nephew Full timeEmpowering Better DecisionsAt Smith+Nephew, we're committed to delivering innovative solutions that take the limits off living.We're seeking a talented Specialist to support our Evidence Analysis team in driving evidence-based decision making and impactful clinical messaging.As a key member of our team, you'll work closely with collaborators to coordinate...
-
Customer Compliance Expert
5 days ago
Watford, Hertfordshire, United Kingdom True North Talent Full timeJob Title: Customer Compliance ExpertLocation: HertfordshireOverview:We are seeking a highly experienced Customer Compliance Expert to join our team. In this critical role, you will be responsible for ensuring that our products meet the highest standards of compliance, quality, and safety.You will work closely with our internal teams to identify areas for...
-
Technical Compliance Specialist
5 days ago
Watford, Hertfordshire, United Kingdom CV-Library Full timeJob Title: Technical Compliance SpecialistA challenging opportunity has arisen for a highly skilled Technical Compliance Specialist to join our team. As a key member of our food industry client's technical team, you will play a crucial role in ensuring that products meet the highest standards of compliance, quality, and safety.The ideal candidate will have...
-
Regulatory Project Management Specialist
6 days ago
Watford, Hertfordshire, United Kingdom Addition Solutions Ltd Full timeWe are looking for a Regulatory Project Management Specialist to join our team at Addition Solutions Ltd in Watford. This role offers an estimated salary of £80,000 - £100,000.About the RoleThis is a 6-month fixed-term contract.You will be responsible for managing the review and updating of strategy, planning, procedures, and policies regarding regulatory...
-
Safety Policy and Compliance Specialist
7 days ago
Watford, Hertfordshire, United Kingdom The Health & Safety Partnership Full timeThe Health & Safety Partnership is seeking a highly skilled Safety Policy and Compliance Specialist to join our team. This role is responsible for developing and implementing comprehensive health and safety policies, procedures, and programs across various industries.About the Role:Develop and implement health and safety policies and proceduresConduct risk...