Regulatory Affairs Associate
3 weeks ago
**Role**:Regulatory Affairs Associate
**Location**:Hemel Hempstead, Hertfordshire
**Salary / Rate of pay**:£40,000
Platinum Recruitment is working in partnership with a popular pharmaceutical business, and we have a fantastic opportunity for a Regulatory Affairs Associate to join their team.
**What's in it for you?**
- Career progression
- Training
- A fantastic product and opportunity
- To work with fantastic people
**Package**
- £40,000
- A full time and permanent role
- 31 days' holiday including statutory holidays, plus birthday
- Health insurance
- Company mobile and laptop
- Contributory pension scheme
- Opportunity to take ownership for your work and to make an invaluable contribution
- Opportunity to develop and excel your career within a company which is rapidly expanding
- Support and cooperation from a close-knit team in brand new modern offices
- Opportunity to attend major international conferences
- International travel
- Be part of a dynamic fun-loving team
**The Role**
Responsibilities will involve:
- Work in conjunction with the Regulatory team on post approval variations, renewals, post marketing commitment submissions and other ad hoc activities in support of maintaining MAs in the EU, MENA, Africa, Asia and the UK.
- Working alongside the commercial department to determine the viability of entering new markets, and the regulatory requirements, timelines and conditions in these markets.
- Developing a thorough and up-to-date understanding of the regulatory environment and supporting data requirements in a number of countries globally.
- Reviewing and submitting artwork and labelling changes.
- Managing external pharmacovigilance, medical information 3rd party agent, local translators, trademark providers, publishing and consular service providers.
- Building and maintaining effective relationships with external clients/partners/local distributors alongside partner's regulatory teams.
- Managing/supporting a range of changing project demands.
- Gap analysis of regulatory documentation, identification of potential challenges and proposal of solutions.
- Developing and maintaining strong working knowledge of regulatory guidelines.
- Keep up to date with Regulatory Changes, including new Regulatory Agency guidance and revisions.
- Ensuring that all relevant electronic systems are updated and maintained in alignment with regulatory submissions and commitments. Maintain, archive and update the regulatory dossiers and projects trackers on a regular basis.
- Ensuring all processes are carried out according to guidelines and standard operating procedures (SOPs).
- Work with logistic team and CMO to review and maintain the artwork and SKU log.
- Review of prescribing information as per ABPI/PMCPA code.
- Review and submissions of PSUR, RMP and CCDS.
- Support for the Annual Product Quality Review (APQR) for relevant product responsibilities.
**Sound like the role for you?**Then we would love to hear from you
**_Don't forget to speak to your consultant about our "Recommend a Friend" referral scheme and find out how you could earn up to £250 per recommendation._
Consultant**:Lisa
**Job Number**:920809
**Job Role**:Regulatory Affairs Associate
**Location**:Hemel Hempstead, Hertfordshire
Platinum Recruitment is acting as an Employment Agency in relation to this vacancy.
-
Regulatory Affairs
3 weeks ago
Hemel Hempstead, United Kingdom PLATINUM RECRUITMENT CONSULTANCY LIMITED Full time**Role**:Regulatory Affairs **Location**:Hemel Hempstead, Hertfordshire **Salary / Rate of pay**:£75,000 Platinum Recruitment is working in partnership with a niche pharmaceutical company, and we have a fantastic opportunity for a Regulatory Affairs to join their team. **What's in it for you?** My client is a fun, young, dynamic company with a rapidly...
-
Regulatory Affairs
3 weeks ago
Hemel Hempstead, United Kingdom PLATINUM RECRUITMENT CONSULTANCY LIMITED Full time**Role**:Regulatory Affairs **Location**:Hemel Hempstead, Hertfordshire **Salary / Rate of pay**:£75,000 Platinum Recruitment is working in partnership with a niche pharmaceutical company, and we have a fantastic opportunity for a Regulatory Affairs to join their team. **What's in it for you?** My client is a fun, young, dynamic company with a rapidly...
-
Regulatory Affairs Executive
2 weeks ago
Hemel Hempstead Industrial Estate, United Kingdom Kenton Black Science & Engineering Full timeRegulatory Affairs Executive Do you want to contribute to the future of healthcare? Do you want to work for a progressive company that offers long term training and development? I working in partnership with a leading healthcare manufacturer, they specialise in the development of new products, using their unique technology platform. Due to growth in the...
-
Regulatory Lead
3 weeks ago
Hemel Hempstead, United Kingdom NECSWS Full timeCompany Description Come join us and make a difference in the world! We’re NEC Software Solutions (part of global tech giant NEC Corporation). While you read this ad, our software is helping to dispatch ambulances, support families, keep trains on the move, locate missing people and even test the hearing of newborn babies. Working with us, you’ll be...
-
Medical Scientific Director
1 week ago
Hemel Hempstead, Hertfordshire, United Kingdom Recordati Full timeAssociate Medical Director - Onco-Hematology Business Area: Medical Full-Time or Part-Time: Full Time With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn. We develop and commercialise...
-
Associate Medical Director
1 week ago
Hemel Hempstead, Hertfordshire, United Kingdom Recordati Full timeAssociate Medical Director - Onco-Hematology ID: 1063 Date of Posting: Dec 14, 2024 Business Area: Medical Job Type: Direct Employee Location: Hemel Hempstead, GB Territory: Full-Time or Part-Time: Full Time Seniority: Director With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical...
-
Corporate Sustainability Manager Uk
2 weeks ago
Hemel Hempstead, United Kingdom Epson UK Full time**Your mission**: The Corporate Sustainability Manager (CSM) is responsible for the management of the full range of activities and projects relating to Epson's Corporate Sustainability mission in the UK and Ireland, as well as partly for certain European projects. The CSM function consists of wide range of responsibilities mainly divided into two parts: -...
-
Risk and Compliance Advisor
2 weeks ago
Hemel Hempstead, United Kingdom Venn Group Full time**Risk and Compliance Advisor** **Agency ref: 67202** An established Housing Association is currently looking to recruit a **Risk and Compliance Advisor** to work within their professional and dedicated Governance team on a permanent basis. **Location**: Hemel Hempstead with 2 days a week from home **Duration**:Permanent **Hours**:35 hours per...
-
Head of Quality
7 months ago
Hemel Hempstead, 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...
-
Contracts & Tenders Specialist
2 weeks ago
Hemel Hempstead, United Kingdom Evolve Selection Ltd Full timeEvolve is recruiting for a leading Medical Device organisation, who is in search of a Contracts and Tenders Specialist based at their head office in Hemel Hempstead. This is a fantastic position for a dynamic and organised individual to join a supportive team in managing the submissions for national and large regional medical device/medicine purchase...
-
Head of Compliance
7 months ago
Hemel Hempstead, United Kingdom Nayax Full timeWe are looking for a** Head of Compliance **who will be responsible for managing an effective and appropriate compliance program and anti-money laundering (AML) and counter-terrorist financing (CTF) for Nayax UK. The emphasis of this position is on leading, developing, operating, and maintaining systems and controls to prevent the firm’s products and...
-
Compliance Assurance Coordinator
4 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Hightown Housing Association Full timeStatutory Compliance ManagerThe Statutory Compliance Manager role at Hightown Housing Association involves overseeing compliance with regulatory requirements across various areas, including building safety, fire safety, and electrical safety.Key responsibilities include developing and implementing policies, procedures, and guidelines to ensure compliance...
-
Organization Development Leader
2 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Griffin Fire Full timeLeadership Opportunity:We are seeking an Organization Development Leader to join our team at Membership Bespoke. As a key member of our leadership team, you will play a critical role in shaping the organization's strategy and direction.Your primary responsibility will be to direct the organization's activities to achieve the objectives within agreed short...
-
Senior Construction Manager
4 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Hamilton Barnes Associates Limited Full timeOverviewHamilton Barnes Associates Limited is a leading construction firm seeking a skilled Senior Construction Manager to oversee significant projects and develop innovative procedures.Estimated Salary Range:$120,000 - $180,000 per annum, depending on experience and qualifications.Job DescriptionAs a Senior Construction Manager at Hamilton Barnes Associates...
-
Senior Construction Leader
3 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Hamilton Barnes Associates Limited Full timeJob Overview: Senior Construction LeaderHamlton Barnes Associates Limited is seeking an experienced Senior Construction Leader to manage customer relations and on-site construction activities. The successful candidate will have a proven track record of overseeing project documentation and resource coordination, while enforcing safety policies and managing...
-
Construction Project Manager
3 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Hamilton Barnes Associates Limited Full timeJob Title: Construction Project ManagerIn this role as a Construction Project Manager with Hamilton Barnes Associates Limited, you will have the opportunity to oversee significant construction projects and develop innovative procedures. Our company thrives in a dynamic team environment where safety and performance are highly valued.The ideal candidate will...
-
Infrastructure Development Manager
3 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Hamilton Barnes Associates Limited Full timeJob OverviewHAMILTON BARNES ASSOCIATES LIMITED is seeking an experienced Construction Project Director to join our team. As a key member of our organization, you will be responsible for overseeing construction projects from initiation to completion, ensuring they are executed according to schedule, budget, and quality standards.Main Responsibilities:Project...
-
Health and Safety Compliance Specialist
3 weeks ago
Hemel Hempstead, Hertfordshire, United Kingdom Hightown Housing Association Full timeAbout Hightown Housing AssociationHightown is a charitable housing association operating in Hertfordshire, Bedfordshire, Buckinghamshire, and Berkshire. Our mission is to provide excellent housing and support to our residents.As Health and Safety Resource Officer for Housing, you will play a vital role in ensuring that we meet our statutory landlord...
-
Construction Project Director
3 months ago
Hemel Hempstead, Hertfordshire, United Kingdom Hamilton Barnes Associates Limited Full timeTransform cityscapes and infrastructure with a career in construction management at Hamilton Barnes Associates Limited.As a Construction Project Director, you will oversee significant construction projects, playing a pivotal role in shaping the built environment.Key responsibilities include managing customer relations, overseeing on-site construction...
-
Credit Control Team Lead
2 weeks ago
Hemel Hempstead, United Kingdom Vitae Financial Recruitment Limited Full timeCredit Control Team Lead Hemel Hempstead (3 days per week in office) £35,000 - £37,000 **Responsibilities**: - Lead and manage the Credit Control team, providing direction and guidance to ensure effective management of tenant arrears. - Monitor and manage tenant accounts, identifying areas of risk and ensuring appropriate actions are taken to maximise...