Graduate Regulatory Affairs Assistant Job at 360 Resourcing Solutions (Keele)

Intern, regulatory information management and technology

The BioMarin Summer Internship Program will enable students to gain valuable exp...

Location

United States

Salary:

24.00 - 27.00 USD / Hour

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Knowledge of the Regulatory Affairs submission process
Proficient computer skills and working knowledge of Microsoft Office (Word, Excel, PowerPoint and Outlook)
Excellent interpersonal, written and verbal communication skills
Strong organizational skills with ability to prioritize and manage tasks in a fast-paced environment
Ability to work independently and collaboratively
Student pursuing a Bachelor’s degree in computerized systems or life sciences (or in related fields of study)
Student must be returning to school in the Fall Term OR has graduated within the 1 year of the start of the program
Must be available to work 40 hours a week
Must be authorized to work in the United States without visa sponsorship

Job Responsibility

Provide Regulatory Data Management and Regulatory Systems Usage/Implementation assistance for Global Regulatory Affairs RIMT group
Utilizing Information Management skills, provide Business Analysis to assist in enhancing existing Regulatory Information management data quality
Assess and reconcile regulatory details associated with Regulatory Health Authority Applications to support both Marketing and Investigational Drug Product authorizations
Providing support for Operational Change Management activities relating to technology improvements related to the Veeva RIM platform

What we offer

Paid hourly wage
Paid company holidays
Sick time
Apply skills and knowledge learned in the classroom to on-the-job experiences
Comprehensive, value-added project(s)
Develop skills specific to your major
Opportunities for professional development by building relationships and learning about other parts of the business
Participate in company all hands meetings, monthly community lunches
Corporate office amenities such as: 24/7 on-site gym, coffee truck, snacks
Access to Employee Resource Groups

Fulltime

Legislative Affairs Specialist III

This is a lobbyist position in the AFSCME Department of Federal Government Affai...

Location

United States , Washington, D.C.

Salary:

102857.00 - 154291.00 USD / Year

American Federation of State, County and Municipal Employees

Expiration Date

Until further notice

Requirements

Graduation from an accredited four-year college with course work in political science, history, or government
Minimum of seven (7) years of related work experience or equivalent combination
Considerable experience in working for labor unions or federal, state or local governments
Considerable experience in oral and written communications including public speaking
Considerable knowledge of the legislative process and the workings of Congress
Thorough knowledge of relevant coalition and support group organizations’ operations
Strong ability to communicate complicated information effectively both orally and in writing
Ability to organize relevant lobbying coalitions
Travel and extended work hours including weekends are required
A valid driver’s license is required

Job Responsibility

Acts as a primary liaison with members of congress, their staff and committees of congress
may appear before congressional committees/groups and travels to state councils to discuss AFSCME’s legislative agenda
Monitors legislative activities, provides analysis and comments on legislation, and advocates for AFSCME’s position on legislation
Develops testimony, letters of support, and other written statements and may serve as AFSCME's spokesperson with members of congress, congressional and agency staff, and interest groups
In consultation with other relevant departments, assists with drafting and revising legislative language
provides briefings on proposed legislation and amendments proposed during legislative sessions
and keeps relevant departments apprised of developments
Serves as a specialist concentrating on major legislative/regulatory issues
In consultation with department leadership, develops grassroots legislative campaign field plans to engage affiliates and coalition partners in campaigns to advance AFSCME’s major legislative priorities
Responds to affiliate and members’ inquiries on a wide variety of legislative and regulatory issues

What we offer

List of benefits

Fulltime

New

Hub Labeling Manager

The Manager is responsible for preparation of LPDs, associated LLDs and PLDs for...

Location

United Kingdom , Tadworth, Surrey

Salary:

40000.00 - 45000.00 GBP / Year

SRG

Expiration Date

Until further notice

Requirements

Life sciences or pharmacy graduate, or equivalent relevant professional experience
Ability to develop positive relationships across cultures and locations
Strong attention to detail and problem‑solving skills
Demonstrated technical aptitude and ability to learn new software quickly
Ability to quickly learn regulations and standards
Hands‑on registration experience in development, maintenance, or commercialization within Regulatory Affairs - ideally from a country office or regional regulatory perspective, especially understanding the implications of a CDS on LPDs
Ability to understand and manage regulatory implications of product strategy relating to labelling
Knowledge of global/regional regulatory guidelines, requirements, and clinical variations
Strong project management and analytical skills
Proficient in systems use consistent with business expectations

Job Responsibility

Monitors system data integrity and performs quality checks
Maintains system management for labelling activities including GDMS and approved labelling tracking systems
Produces labelling‑related documentation for submission to HAs such as tracked‑change versions, annotated labels, comparison tables, and annotated supporting documentation
Performs QC checks on work produced by colleagues
Identifies incremental improvements to labelling‑related processes and systems for exploration by senior labelling managers
Meets defined productivity, quality, and compliance targets as set by management
Utilizes regulatory labelling expertise to review, develop and deliver labelling documents for submission to Regulatory Authorities across markets/regions, requesting medical input as appropriate
Supports other deliverables within ILG responsibilities (e.g., readability testing)
Contributes to projects involving current and new global tools, technologies, and processes supporting label development, submission, and approval - with a focus on digital solutions
Participates in research incubator initiatives involving automation, machine learning, BPM, etc.

Fulltime

Director of Quality Assurance, Clinical

Responsible for leading in the development, implementation and maintenance of QA...

Location

United States , Berkeley

Salary:

220000.00 - 235000.00 USD / Year

Caribou Biosciences

Expiration Date

Until further notice

Requirements

Undergraduate or graduate degree(s) in Biological Sciences, Chemistry, or related Science discipline
At least 15 years of experience in clinical quality assurance (GCP, GLP and PV) in cell & gene therapy/biotechnology and/or pharmaceutical industry
Experience working in biologics is strongly preferred
Subject Matter Expert (SME) working knowledge on current interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research
Proven track record in developing and implementing quality systems and processes in a clinical setting
Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits
Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
Prior GLP experience with quality oversight and auditing studies/vendors (preferred)
Excellent verbal and written communication skills
Ability to lead cross-functional teams and independently prioritize work

Job Responsibility

Compliance Oversight: Ensure that all clinical trial activities comply with guidelines and international regulations (e.g., ICH-GCP and ICH-PV), and applicable laws
Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements
Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams
Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of product pipeline
Plan and oversee activities in support of regulatory submissions and inspections
Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI)
Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA, EU and ROW regulations/directives/requirements and ICH guidelines
Quality Management System (QMS): Maintain and enhance Caribou’s QMS by implementing processes and procedures that ensure consistent adherence to GCP, GLP and PV standards throughout the clinical trial lifecycle
Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents
Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders

What we offer

Comprehensive compensation package, which includes competitive salary, bonus, and equity for all employees
Generous paid vacation time, in addition to company-observed holidays
Excellent medical, dental, and vision insurance
401(k) retirement savings plan, which includes matching employer contributions
Employee stock purchase plan (ESPP)
Tuition reimbursement program

Fulltime

New

Catering Assistant

Do you speak the language of coffee with passion, love and energy? Do you delive...

Location

Ireland , Tallaght, Co Dublin

Salary:

14.15 - 14.70 EUR / Hour

Baxter Storey

Expiration Date

Until further notice

Requirements

Friendly, outgoing personality
Great work ethic
Good listening & verbal communication skills
Passion for delivering outstanding customer service
Perpetuates company philosophy and culture
Works according to the BaxterStorey core values
Have a contagious passion for coffee, tea and customer service
You draw satisfaction from working within a collaborative and inclusive team environment
Ability to adapt to challenges and opportunities with a solution-oriented perspective
Previous experience in a similar role, especially in the food service industry, is often a plus

Job Responsibility

Delight our customers by greeting them in a friendly and professional manner
Efficiently prepare and serve a variety of coffee beverages, teas, and other drinks using the correct methods, equipment and to our standards
Share the story of our menu, and provide recommendations to customers and be aware allergen procedures
The pride in your workspace, maintaining cleanliness and organisation of the coffee bar and other surrounding areas in line with cleaning schedules, company and COSHH standards
Follow all health and safety and food safety guidelines and procedures
Monitor stock levels and restock supplies as needed
Use till systems for taking payments and customer orders
Provide exceptional customer service and resolve any customer issues or complaints
Be a part of the team assisting on other tasks as needed

What we offer

Pro Rata holiday
Plus your birthday off
3 paid volunteering days
3 days paid grandparent leave
26 week’s enhanced maternity leave
Secondary carer leave (enhanced leave)
Paid Wedding/commitment day leave
Free meals on shift
Bespoke training and development opportunities
Apprenticeships opportunities for all experience levels

Fulltime

New

Retail Manager - Catering

Do you have a passion for leading the way in providing genuine hospitality and i...

Location

United Kingdom , London

Salary:

40000.00 GBP / Year

Baxter Storey

Expiration Date

Until further notice

Requirements

You thrive on getting the best out of people and maximising commercial opportunities
You draw satisfaction from managing, training and supporting a team
Passionate and skilled in creating effective marketing and engagement plans
You demonstrate a genuine passion for food & service, with a strong eye for detail in service standards, innovation and merchandising
You provide a professional catering service, ensuring that company standards are maintained and that Client expectations are met
Have experience commensurate with role
Thrive on delivering a great customer experience and leading by example
Able to demonstrate your analytical approach to problem solving

Job Responsibility

Management responsibility for food and beverage operations in multi tenant building
Use your foodie skills to inspire the chef team and evolve the menu
Develop beverage offer across three cafe spaces
Invigorate bar sales and engagement with bespoke activities
Use data to inform and shape the way we work
Lead, inspire, collaborate and support your direct reports to deliver consistently exceptional standards
Build positive, credible and collaborative relationships & communication methods with clients and other key stakeholders in the business
Continually look to develop your team through mentoring, training, recognition, and empowerment
Create a culture of excellence with your team, continually striving to push the boundaries of brilliance through natural caring service, obsessive food standards and innovation
Achieve business critical KPI's including Health and Safety, Sustainability, Financial and Governance

What we offer

28 Days holiday including bank holidays
Plus your birthday off
3 volunteering days
3 days grandparent leave
24 weeks enhanced maternity leave
Secondary carer leave
Wedding/commitment day leave
Free meals on shift
Bespoke training and development opportunities
Apprenticeships opportunities for all experience levels

Fulltime

New

Relief Catering Assistant

Do you have a passion for providing genuine hospitality and impeccable service? ...

Location

United Kingdom , Aberdeen

Salary:

12.60 GBP / Hour

Baxter Storey

Expiration Date

Until further notice

Requirements

Have a contagious passion for food and/or customer service
You draw satisfaction from working within a collaborative and inclusive team environment
Ability to adapt to challenges and opportunities with a solution-oriented perspective
Previous experience in a similar role, especially in the food service industry, is often a plus
Some knowledge of food safety and sanitation practices
Works according to the BaxterStorey core values
Must have own transport as this is a mobile role

Job Responsibility

Service – serve food and beverages to guests in a friendly and professional manner
Ensure that guests’ needs and requests are efficiently and effectively addressed
Customer Service - provide excellent service by being attentive to guests’ needs at every point on their customer journey
Answering questions and addressing any concerns or issues in a friendly manner
Teamwork - collaborate with all other staff to ensure the smooth flow of operations
Support and contribute to creating an inclusive and safe working environment
Adherence to Regulations - comply with health and safety regulations, as well as any specific food service or catering guidelines established on location
Cleanliness - maintain cleanliness and hygiene standards in the kitchen and dining areas

What we offer

20 Days holiday plus bank holidays
Plus your birthday off
3 volunteering days
3 days grandparent leave
26 week’s enhanced maternity leave
Secondary carer leave
Wedding/commitment day leave
Free meals on shift
Bespoke training and development opportunities
Apprenticeships opportunities for all experience levels

Fulltime

New

Hospitality assistant

Are you personable, attentive, and capable of providing exceptional service whil...

Location

United Kingdom , Filton, Bristol

Salary:

22950.20 - 23000.00 GBP / Year

Baxter Storey

Expiration Date

Until further notice

Requirements

Previous experience in a similar role, especially in the food service industry & serving large events
Good attention to detail & flare
Strong communication and interpersonal skills
Ability to adapt to challenges and opportunities with a solution-oriented perspective
Knowledge of food safety and sanitation practices
Driving licence required as will have use of a work van to support with the transporting of food & beverages for hospitality around the site

What we offer

28 Days holiday inclusive of bank holidays
Birthday additional holiday
3 days volunteering days
3 days grandparent leave
24 week’s enhanced maternity leave
Secondary career leave
Wedding/commitment day leave
Free meals on shift
Bespoke development training
Pension and life insurance

Fulltime

Graduate Regulatory Affairs Assistant

360 Resourcing Solutions

Location:
United Kingdom , Keele

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 12, 2026

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