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Technical and Regulatory Associate, for a leading materials manufacturer based in the East Yorkshire area.

- Are you passionate about chemical regulatory compliance?

- Do you want variety including lab and commercial based activities?

- Are you looking to work with a fantastic and supportive team environment?

If you answered Yes to all the above, then read on for more information about this great oppo click apply for full job details

Your new company
We are seeking an experienced Regulatory Affairs Specialist to join the Technical Documentation team on a contract basis.This is an excellent opportunity for a regulatory professional with strong IVD/IVDR expertise to play a key role in the preparation, remediation, and maintenance of technical documentation supporting a complex product portfolio click apply for full job details

Regulatory Affairs Specialist - Medical Devices

Newton Colmore is working with a medical devices company in Cambridge who are looking to hire a regulatory affairs scientist/engineer to join their team.

This role will give you an opportunity to take lead on quality assurance and regulatory affairs matters across this international organisation. Although the role will have a focus on medical devices, it will also provide you with experience of new highly regulated industries.

Because this company conducts R&D and manufacturing across the world you will be working to European, American, and Asian standards and so will give you a varied project scope.

You will be reporting directly to the QA Director and the principal analyst within the team and will be charged with running quality and regulatory focused initiatives within the company and find novel solutions to new and existing problems with projects and management systems.

This company will reward you with a tailored salary and package to suit your expectations, with bonuses, free lunches, and a variety of further benefits. The company pride themselves on their training and development as well as the highly technical nature of their work and so this role could be a great next step for your career.

For more information make a confidential application now and a member of our team will be in touch with more details.

Your new company
An established and growing organisation operating within the Medical Device and Healthcare sector. With a strong commitment to quality, compliance and innovation, the business develops and manufactures products that have a direct impact on patient outcomes. As the organisation continues to expand its manufacturing capabilities and product portfolio, it is seeking an experienced qu click apply for full job details

• Publications Lead (Medical Affairs)
• Remote Working (London + WFH)
• £575 to £600 per day
• 12-month contract (Inside IR35 / via Umbrella)

The Opportunity:

ISR Recruitment is currently supporting a global biopharmaceutical organisation with the appointment of an experienced Publications Lead for Medical Affairs on an initial 6-to-12-month contract opportunity.

This is a high-priority opportunity within a Cell Therapy portfolio, supporting the delivery of scientific publications across key programmes during an important period of activity.

The successful contractor will work alongside existing Publications Leads, providing additional leadership, executional support and flexibility across the portfolio.

This role would suit an experienced publications professional who can quickly embed themselves within an established team, independently taking ownership of key deliverables and managing competing priorities.

Skills and Experience:

We are looking for an experienced medical publications professional who can operate effectively in a fast-moving, compliance-driven pharmaceutical or biotechnology environment.

You will ideally have:

• An advanced degree such as PhD, PharmD, MD or MSc in Life Sciences or a related discipline.
• 5 to 7 years' experience in medical publications within pharma, biotech, medical communications or a closely related environment.
• Strong understanding of ICMJE and GPP publication guidelines.
• Proven experience managing scientific publications from planning through submission and post-publication.
• Experience across manuscripts, abstracts, posters and presentations.
• Experience working with medical writing agencies and external vendors.
• Strong organisational and prioritisation skills, with the ability to manage multiple parallel workstreams.
• Confidence stepping into partially developed or in-flight projects.
• Excellent stakeholder management and communication skills.
• A pragmatic approach to working within a highly regulated and compliance-driven environment.
• Exceptional attention to detail and a strong quality mindset.

Role and Responsibilities:

You will provide flexible publication leadership across priority programmes, taking ownership of specific publications, workstreams and assets as required.

Your responsibilities will include:

• Partnering with existing Publications Leads to support delivery of publication plans across priority programmes.
• Taking the lead on individual publications, workstreams and assets where additional support is required.
• Providing additional bandwidth during peak periods, including congress timelines and key data readouts.
• Leading the end-to-end development and execution of manuscripts, abstracts, posters and presentations.
• Managing the publication lifecycle from initial planning through submission and post-publication activities.
• Tracking publication milestones, timelines and deliverables through publication trackers and calendars.
• Working closely with Medical Affairs, Clinical, Health Economics and Outreach Research (HEOR) and other cross-functional stakeholders.
• Liaising with authors, investigators and external experts.
• Supporting publication planning discussions and associated decision-making.
• Providing direction to medical writing agencies and reviewing deliverables for scientific quality.
• Managing timelines, risks, dependencies and competing priorities across multiple deliverables.
• Ensuring efficient collaboration between internal teams and external partners.
• Ensuring publications comply with relevant guidelines and internal policies, including ICMJE and GPP.
• Maintaining scientific rigour, accuracy and quality across all outputs.
• Supporting audit-ready documentation and adherence to publication processes.

Applications:

To learn more about this opportunity consulting on a temporary contract as a Publications Lead (Medical Affairs) for a global pharmaceutical business based in West London; please call and speak with Edward Laing here at ISR Recruitment or please share a copy of your very latest CV and/or online business profile for a call back in the very strictest of confidence.

This is an excellent opportunity for a senior publication professional to join a high-profile global biopharmaceutical environment and make an immediate contribution across a priority Cell Therapy portfolio.

If you have strong medical publications experience and can quickly take ownership of complex publication deliverables, we'd be very interested in hearing from you.

Regulatory Affairs Specialist - Dundee - Office Based.

The Regulatory Specialist is a key member of the Compliance Team, responsible for supporting and maintaining regulatory compliance across the business. The role focuses on ensuring that products, processes and quality systems meet applicable UK, Swiss, EU and international regulatory requirements.

Working closely with internal stakeholders and regulatory authorities, the Regulatory Specialist provides regulatory expertise across product registrations, vigilance, regulatory intelligence, change assessments and technical documentation.

Key Responsibilities

• Manage regulatory activities
• Oversee regulatory compliance activities including vigilance, regulatory intelligence, change assessments and regulatory submissions.
• Act as a key point of contact with regulatory authorities, including the MHRA and Swissmedic.
• Manage product inclusion activities for the UK and Swiss markets, ensuring products meet relevant regulatory requirements.
• Assess changes to regulatory requirements, legislation and quality standards and determine their impact on the Quality Management System.
• Support the implementation of regulatory and quality requirements across the organisation.
• Manage and maintain technical documentation
• Provide clear regulatory advice and communicate effectively with internal stakeholders, including executive-level leadership.
• Support the ongoing development and maintenance of quality and compliance systems.
• Identify opportunities to improve regulatory processes, communication and productivity.
• Maintain awareness of relevant company policies, regulatory requirements and industry best practice.
• Support other compliance and regulatory activities as required by the Compliance Manager.

Experience & Qualifications

• Degree or equivalent qualification, preferably within a life sciences discipline.
• Relevant experience within the life sciences, medical device or similarly regulated industry.
• Experience within the In-Vitro Diagnostics (IVD) sector would be advantageous.
• Strong knowledge of Quality Systems, Quality Assurance and regulatory compliance.
• Knowledge of relevant standards and regulations, including ISO 13485, 21 CFR, MDSAP, EU IVDD/IVDR and ISO 14971.
• Experience working with Electronic Document Management Systems (EDMS).
• Proficiency in Microsoft Word, Excel and PowerPoint.

Skills & Competencies

• Strong attention to detail with a high level of accuracy.
• Excellent organisational and time-management skills.
• Strong written and verbal communication skills.
• Confident communicating with senior and executive-level stakeholders.
• Ability to interpret regulatory requirements and assess their impact on business and quality systems.
• Self-motivated, proactive and committed to continuous professional development.
• Able to work effectively both independently and as part of a small, collaborative team.

About the Role

We are looking for a motivated, capable and experienced individual to join our dynamic Policy and Public Affairs Team. The postholder will play a key role in developing credible, evidence based policy proposals and influencing UK governments, NHS organisations and other relevant bodies to adopt them.

Key tasks and responsibilities include (but are not limited to):

• Collating and analysing existing qualitative and quantitative research to generate policy proposals and facilitate their implementation.
• Conducting and/or commissioning new research, such as survey work or interviews, to fill evidence gaps where necessary in support of policy and influencing work.
• Proposing and implementing influencing plans related to policy work, including meeting stakeholders and developing influencing materials.
• Preparing and drafting responses to consultations and reports relevant to the work of Centre for Perioperative Care (CPOC) and the College, ensuring responses are evidence-based and in line with on-going policy work and strategy.
• Developing effective and impactful briefings for meetings, events and engagements where necessary, ensuring that information is presented in concise, clear and accurate information.

About You

To succeed in this role, you will be highly organised and able to deliver high-quality work at pace while effectively managing competing priorities.

You will be eager to learn and confident in building strong, collaborative relationships with a wide range of stakeholders.

You will have demonstrable experience of developing credible, deliverable and evidence-based policy proposals, alongside experience of conducting and collating quantitative and/or qualitative research to support policy development. You will also be able to demonstrate your ability to use research and evidence to effectively influence senior stakeholders.

A good understanding of current UK health policy and the wider health policy environment is essential.

You will need to be educated to degree level or have equivalent relevant experience.

The Package

This is a full-time, permanent position with a competitive employee benefits package, which includes (but is not limited to):

• 26 days of annual leave, plus bank holiday.
• 1 additional paid day of leave for the purpose of celebrating your birthday.
• Healthcare support through Benenden Health.
• Up to 12% pension contribution.
• Hybrid and flexible working.
• Wellbeing hour once a week.
• Cycle to work and employee discounts schemes.
• Training and development opportunities.
• Access to Mental Health First Aiders and Employee Assistance Programmes.

About the College

The Royal College of Anaesthetists (RCoA) is the professional body responsible for the specialty throughout the UK. We are the third largest medical royal college in the UK by membership. With a combined membership of more than 24,000 Fellows and Members, we ensure the quality of patient care by safeguarding standards in the three specialties of anaesthesia, intensive care and pain medicine.

At RCoA equality, diversity and inclusion is an integral part of our culture so it is important to us that this is reflected in everything that we do. We welcome applications from all individuals irrespective of age, race, gender, sexual orientation, ethnicity, religion or belief, disability, marital status, or parental responsibilities to ensure we actively embrace an inclusive and representative culture that encourages, supports and celebrates our differences.

What We Want to Achieve

We want to see an NHS that delivers good outcomes for patients and makes the best use of available resources.

Our current main priorities are:

• Optimising the surgical pathway. Anaesthetists don t just work in the operating theatres they are often involved with the care patients receive before and after their operations known as perioperative care . Good perioperative care can prevent surgical cancellations, complications, and unnecessarily long hospital stays. To this end, we host the Centre for Perioperative Care (CPOC). CPOC advocates policies such as prehabilitation to ensure that patients arrive in hospital on the day of their surgery in the healthiest state possible so their operation can go ahead without problems, and they can recover quickly. We are doggedly pushing for such polices to be adopted.
• Supporting the anaesthetic workforce. Most operations require an Anaesthetist in order to take place, but each of the four UK nations faces a chronic shortage of Anaesthetists. We are determined to see this changed.

How to Apply

If you believe that you are the right person for this role, please submit your CV and cover letter by Sunday, 1st of November. In your cover letter, please address clearly how your experience meets the essential criteria in the job description in no more than 600 words.

Please note that the closing date may be brought forward should we receive a high volume of suitable applications.

Due to the volume of applications received, we are unable to provide individual feedback to external candidates. Only shortlisted applicants will be contacted following the closing date.

Applicants must have the right to work in the UK and be resident in the UK at the time of

application.

No agencies please.

Hub Submission Manager

Job Type: Temporary
Location: Sandwich, Kent
Duration: 6 months
Rate: circa. 17.60 per hour

Role Summary

We are seeking an experienced Hub Submission Manager to join a global regulatory operations team within a highly regulated pharmaceutical environment. This position is responsible for the operational management, coordination and delivery of regional and national regulatory submissions to health authorities, ensuring compliance with regulatory requirements and critical business timelines. The successful candidate will work across multiple markets and stakeholders, managing submission activities from planning and dossier preparation through to delivery and archival, while driving process improvements and operational excellence.

Key Responsibilities

• Lead and coordinate regulatory submission activities for assigned products, markets and regulatory procedures.
• Manage the planning, compilation, technical build and delivery of electronic and paper regulatory dossiers to health authorities worldwide.
• Partner with regulatory teams, country representatives and external stakeholders to ensure submission requirements, timelines and translation activities are effectively managed.
• Monitor submission milestones, identify risks and proactively resolve issues that could impact regulatory delivery schedules.
• Drive continuous improvement initiatives, supporting the development and implementation of more efficient submission processes and technologies.
• Act as a subject matter expert for submission processes, providing guidance, training and support to colleagues and project teams.

Skills, Experience & Qualifications

• Experience coordinating regulatory submissions within a pharmaceutical, biotechnology or life sciences environment.
• Strong project management and organisational skills, with the ability to manage multiple complex priorities simultaneously.
• Knowledge of regulatory submission requirements, dossier structures and applicable filing guidelines across regional and national markets.
• Experience with electronic submission systems, document management platforms and regulatory technologies.
• Bachelor's degree in Pharmacy, Life Sciences, Business, Information Technology or a related discipline, or equivalent professional experience.
• Excellent communication and stakeholder management skills, with the ability to work effectively across global teams and multicultural environments.

What's on Offer

• Opportunity to work within a global regulatory operations function supporting international product submissions.
• Exposure to a wide range of markets, regulatory procedures and health authority interactions.
• Collaborative environment with opportunities to contribute to process improvement and innovation.
• Involvement in business-critical projects supporting the development and maintenance of pharmaceutical products.

If you thrive in a fast-paced regulatory environment and have a passion for delivering high-quality submissions on a global scale, we would love to hear from you.

Guidant, Carbon60, Lorien & SRG - The Vertage Group Portfolio are acting as an Employment Business in relation to this vacancy.

Talentmark are recruiting for a Compliance and Oversight Lead Manager to join a company in the pharmaceutical industry on a contract basis for 12 months. This role is fully remote and part-time, 20 hours per week.

Company:
Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

Salary:
Up to 49.19 per hour (20 hours per week)

Compliance and Oversight Lead Manager Role:

• Produce project reports and line listings to support resource planning.
• Maintain SharePoint pages, trackers and knowledge-base content.
• Run routine process and quality monitoring, and support investigations when needed.
• Check system data for accuracy and follow up with experts to fix discrepancies.
• Identify trends and coordinate improvement projects, including job aids and work instructions.

• Bachelor's degree or equivalent experience; regulatory affairs background welcome.
• Experience in a global pharmaceutical setting, ideally in labelling or regulatory affairs.
• Proven project coordination, delivering on time and to a high standard.
• Clear written and verbal communication, including summarising data for stakeholders.
• Independent, organised and analytical, with continuous improvement experience a plus.

Recruitment and Compliance Coordinator

Location: Croydon, South London

Hours of work: Full time, Monday to Friday

Salary: Up to 31,000 D.O.E plus bonus

Benefits:

• 25 days annual leave plus bank holidays
• Birthday day off
• Loyalty rewards at 3 and 5 years
• Refer-a-friend scheme
• Workplace pension
• Genuine progression opportunities

We're looking for a Recruitment and Compliance Coordinator to join our Croydon office, where you'll be responsible for interviewing, onboarding and supporting Healthcare Assistants, Support Workers and Registered Nurses through to their first day.

Unlike a traditional recruitment role, there is no candidate sourcing or cold calling. Our dedicated Central Recruitment Team manages candidate attraction, screening and interview bookings, allowing you to focus on interviewing candidates, assessing their suitability and guiding them through the onboarding and compliance process.

You'll be responsible for:

• Interviewing and onboarding Healthcare Assistants, Support Workers and Registered Nurses.
• Conducting up to 6 online and face-to-face interviews per day in a fast-paced, high-volume environment.
• Assessing candidates' skills, experience and suitability against the needs of our service users.
• Guiding candidates through onboarding, compliance, induction and training.
• Ensuring candidates complete all pre-employment checks and are fully prepared for their first shift.
• Delivering a positive candidate experience from interview through to their first day.
• Working closely with our Central Recruitment Team, who manage candidate attraction, screening and interview bookings, allowing you to focus on interviewing and onboarding rather than candidate sourcing or cold calling.

What we're looking for:

• Previous experience in recruitment, recruitment compliance or recruitment onboarding (Essential)
• Strong interviewing skills
• Excellent communication and relationship-building ability
• A genuine passion for care
• Full UK driving licence and own vehicle (essential)

Interested? We'd love to hear from you. Apply now to be considered for this exciting role!