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

Regulatory Affairs Specialist

Regulatory Affairs - office based - Bogota. ICON plc is a world-leading healthca...

Location

Colombia , Bogota

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in Pharmaceutical Chemist or next to graduate required
Minimum 1 year of experience in regulatory area within the pharmaceutical or biotechnology industry
Knowledge or awareness of current regional guidelines and regulations is preferred
Technical knowledge in the preparation of a dossier is desirable
Prior experience using computerized information systems required: PC Windows, word processing and electronic spreadsheets
Advanced English level

Job Responsibility

Manage activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), and any other central authorities for the assigned country/ countries
Perform submission and maintenance of new health records, renovations and modifications to keep the products on the market according to the strategic plan established by the company, current Colombian laws and current local health legislation in accordance with the corporate guidelines and policies, procedures and premises
Review of promotional materials for products for human use of their therapeutic line(s) in Veeva Vault or current tool
Perform submission and monitoring of products for human use of their therapeutic line(s) in procedures such as: PSUR, DSUR, RMPs, and safety information according to current Colombian regulations
Back-up to the Head of Regulatory Affairs and analysts of records in the procedures of INVIMA in order to guarantee the operation of the area
Ensure that IP labels are in adherence to country requirements and submitted where applicable
Support the senior level regulatory staff/country consultant in the maintenance of accurate, up-to date Country Knowledge repositor
Contribute to the maintenance and collection of regulatory intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up-to-date and communicate new information or changes to the Regulatory Intelligence Consultant team
Preparation of electronic regulatory submission of post-registration requests, HMPs, Labeling notifications, additions, publication corrections and database corrections, among other petitions to be field at MoH
Follow-up on the status of the regulatory submissions (paper dossiers) from dispatch to the receipt of proof of protocol

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Regulatory Affairs & Quality Assurance Associate

NYES is looking for a motivated, detail-oriented Regulatory Affairs & Quality As...

Location

United States , Brooklyn

Salary:

Not provided

New York Embroidery Studio

Expiration Date

Until further notice

Requirements

Recent Regulatory Affairs and Quality Assurance (RAQA) Graduate Program
1–2 years of experience in a regulated industry (MedTech, Biotech, or Pharma)
Internship experience in RA/QA is highly valued
Understanding of FDA Class I and II medical device classifications
Familiarity with ISO 13485 and 21 CFR 820 frameworks
High level of technical writing proficiency
attention to detail
a "student of the craft" mentality
A clear desire to grow into a leadership role within NYES

Job Responsibility

Assist the Manager in the daily maintenance of the ISO 13485 Quality Management System, including document control and CAPA tracking
Support the preparation of FDA 510(k) premarket notifications and NIOSH approval packets for N95 respirators and surgical masks
Perform routine checks to ensure manufacturing processes align with 21 CFR Part 820 (Quality System Regulation)
Draft and update Standard Operating Procedures (SOPs), labeling, and IFUs (Instructions for Use) to ensure accurate regulatory claims
Work with third-party labs to track ASTM barrier performance testing (fluid resistance, viral penetration) and organize results for regulatory dossiers
Participate in internal audits and assist in preparing the facility for external inspections from the FDA or Notified Bodies

What we offer

Direct Mentorship: Learn from a veteran Lead with 5–10 years of specialized PPE experience
Clear Career Path: This isn’t just a job
it’s a prepared seat
Impact: Your work ensures that frontline healthcare workers receive PPE that is safe, cleared, and effective

Fulltime

Regulatory Affairs Intern

The RA Intern provides support for a variety of Regulatory Affairs activities re...

Location

United States , Tempe

Salary:

Not provided

BD

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required, and currently enrolled in an undergraduate or graduate school program, or recent graduate
Ability to plan and schedule multiple priorities in a concurrent fashion
Ability to review, collate and summarize scientific and technical data
Good problem solving and analytical skills
Good written and oral communication skills
Work across full suite of Microsoft office software programs, Adobe, and multiple internal software programs/databases

Job Responsibility

Provide general RA support for regulatory projects, under the direction of an RA professional
Effectively manage multiple competing priorities and work in a regulated environment
Assist with the collection of project related documentation and assist with preparation of regulatory submissions
Liaise with the subject matter experts to collect information and communicate with the team members
Assist in auditing, editing and publishing of regulatory submissions as appropriate

Regulatory Affairs Intern

The RA Intern provides support for a variety of Regulatory Affairs activities re...

Location

United States , Tempe

Salary:

Not provided

BD

Expiration Date

Until further notice

Requirements

High school diploma or equivalent required
Currently enrolled in an undergraduate or graduate school program, or recent graduate
Ability to plan and schedule multiple priorities in a concurrent fashion
Ability to review, collate and summarize scientific and technical data
Good problem solving and analytical skills
Good written and oral communication skills
Ability to work in a regulated environment

Job Responsibility

Provide general RA support for regulatory projects, under the direction of an RA professional
Effectively manage multiple competing priorities
Assist with the collection of project related documentation and assist with preparation of regulatory submissions
Liaise with the subject matter experts to collect information and communicate with the team members
Assist in auditing, editing and publishing of regulatory submissions as appropriate
Work across full suite of Microsoft office software programs, Adobe, and multiple internal software programs/databases

Governmental & Regulatory Affairs Intern

Internship within the Regulatory Affairs team, which supports business operation...

Location

United States , Las Vegas

Salary:

Not provided

UFC

Expiration Date

Until further notice

Requirements

Currently enrolled in a Bachelor’s or Graduate degree program in a relevant field such as Legal Studies, Sports Management, Business, Public Policy, or a similar discipline
Junior, Senior, or Graduate-level standing preferred
Ability to organize information and support the presentation of analysis and concepts
Ability to handle confidential information with discretion and professionalism
Strong organizational skills with a high level of attention to detail
Working knowledge of Microsoft Office programs: Word, Excel, PowerPoint, and Outlook, with the ability to learn additional systems
Eager to learn, take initiative, and grow in a fast-paced environment

Job Responsibility

Maintain and organize digital and physical regulatory records, including printing, scanning, and filing documentation
Assist with managing and reviewing Commission Officials’ credentials in advance of upcoming events
Support the updating and maintenance of regulatory-related spreadsheets and tracking tools
Participate alongside Regulatory team members in advance event preparation calls with Athletic Commissions
Collaborate with internal departments to help ensure alignment and understanding of event-specific rules and regulatory requirements
Support the Regulatory team on additional projects and administrative tasks as needed

What we offer

Paid internship
Hands-on experience and exposure to the global sports and entertainment industry
Participation in events such as welcome/farewell sessions, a speaker series featuring company leaders, and career training workshops addressing everything from LinkedIn profile enhancement to resume building, interviewing skills, and networking

Fulltime

Dean, Malcolm Baldrige School of Business

Post University invites applications for the position of Dean, Malcolm Baldrige ...

Location

United States , Waterbury

Salary:

Not provided

Buffkin / Baker

Expiration Date

Until further notice

Requirements

Terminal degree reflective of one or more disciplines within the Malcolm Baldrige School of Business
Minimum of five years of experience in higher education leadership or a related professional field
Significant online experience is strongly preferred
Knowledge of and experience in adult education (theory, pedagogy, and andragogy) as it relates to online, on campus and blended learning modalities
Demonstrated knowledge of current research and state and/or national initiatives to enhance students access, persistence, and success
Proficiency in designing and teaching courses online
demonstrated success in academic higher education program and curriculum development
experience with faculty/staff professional development
Experience with budgets and fiscal management
A proven record of effective, inspirational leadership through collaborative and shared decision-making

Job Responsibility

Model Post's non-negotiable behaviors with all audiences, all the time
Adopt innovative strategies and data informed decision-making in support of Post's smart growth as a global employer
Ensure academic integrity in all academic department informational communications – internal or external
Demonstrate expertise in effective, student-centered, success-oriented, and ethical leadership
Establish and launch the school's mission, shared vision, and identity
Build the strength relevancy of the MBSoB name locally, regionally, and nationally by establishing relationships with counterpart institutions, transfer institutions, local business/industry partners, K-12 partners, and the Post University community
Actively participate in the university's senior leadership team to support the university-wide strategic planning process with the specific accountability and advocacy for the school
Provide leadership in the development, enhancement, and review of academic policies
Ensure timely and transparent information communication across the School, Academic Affairs, and/or the University
Enhance the ethos of collaboration and respect among all Faculty, Associates, and Students

Fulltime

Intern, Medical Operations - Oncology

At Amgen, if you feel like you’re part of something bigger, it’s because you are...

Location

Canada , Mississauga

Salary:

58000.00 - 72000.00 CAD / Year

Amgen

Expiration Date

Until further notice

Requirements

Currently enrolled in (or recently graduated from within the last 3 years) an undergraduate or graduate program in Life Sciences, Business/Marketing, Computer Science, Instructional Design, or a related field
Strong research and writing skills
ability to simplify complex concepts clearly
High attention to detail and comfort working through iterative testing and feedback cycles
Strong collaboration skills and curiosity to learn in a fast-moving environment

Job Responsibility

Support the Medical Affairs team in the strategic development and execution of the Medical tactics
Operational support with budget, contracting and payments for medical tactics
Ensure quality and compliance in all activities
Be involved in the scientific content of all activities i.e. getting necessary approval of slides decks etc
Be the point of contact for partnership with Strategic Meeting Management (SMM) & Centre of Excellence (COE) for all activities
Assist in coordinating accredited continuing medical education and learning activities with Medical Advisor
Support the development of scientific advisory boards and speaker programs
Plan and coordinate Scientific Affairs activities at key scientific congresses
Manage vendors and consultants and project budgets
Takes independent action on handling requests

Fulltime

Senior Manager, Hub Labeling

Is responsible for executing the content management of LPDs, LLDs and PLDs for n...

Location

Australia , Sydney

Salary:

Not provided

Pfizer

Expiration Date

Until further notice

Requirements

Life sciences, pharmacy graduate or equivalent
or equivalent relevant professional experience
Advanced academic qualifications/degree such as PhD
Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations
Demonstration of attention to detail and problem-solving skills
Proven technical aptitude and ability to quickly learn new software
Proven technical aptitude and ability to quickly learn regulations and standards
‘Hands on’ registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs
preferably from the perspective of a Country office or Regional Regulatory Strategy important and advantageous especially with the perspective of the implications of a Core Data Sheet on LPDs
Ability to understand, assess and manage the regulatory implications of product strategy with regard to the product label

Job Responsibility

Is responsible for executing the content management of LPDs, LLDs and PLDs for nationally registered products for their assigned products across multiple countries/regions
Acts as a subject matter expert for local labeling throughout the organisation, leading or assisting in the most complex labeling projects or initiatives, and contributing to the use and development of current and new tools, technologies and processes to support global label development, submission and approval
Sharing of intelligence and contribution to knowledge resources is also a key part of the role
The Senior Manager is proactive in gathering, assessing and disseminating regulatory intelligence for use by the labeling managers as well as for use in strategic decision-making at the global group level
The Senior Manager will insightfully seek technology solutions leveraging process automation and Artificial Intelligence (AI)
May lead/manage projects
May supervise/lead colleagues/teams
May act as delegate/deputy for the TLs
To utilize regulatory labeling expertise to review, develop and deliver labeling documents for submission to the Regulatory Authorities across markets/regions, requesting medical advice and input from other functions as appropriate
To support provision of other deliverables within the scope of ILG responsibilities e.g. readability testing

What we offer

Paid parental leave
Access to Health & Wellness apps
Career Growth Experiences program
Recognition & rewards program
Paid volunteer days
Life Insurance Benefits
Pfizer Learning Academy access to top content providers
Access to flu vaccines & skin checks
Options to purchase additional leave
Salary packaging & novated lease options

Fulltime

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Graduate Regulatory Affairs Assistant

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