Regulatory Affairs Coordinator Job at Randstad (Montevideo)

Regulatory Affairs Coordinator

The Regulatory Affairs Coordinator maintains regulatory documents related to res...

Location

United States , Bethesda

Salary:

31.25 - 36.06 USD / Hour

THE GENEVA FOUNDATION

Expiration Date

Until further notice

Requirements

Bachelor’s degree or equivalent work experience required
Regulatory and IRB submission experience required
2-4 years’ experience in clinical research experience preferred
2-4 years non-profit, research, or healthcare experience desired
Demonstrate competence in oral and written communication
Must be organized, strong attention to detail, and possess a positive, friendly and professional demeanor
Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software

Job Responsibility

Prepare and/or track Institutional Review Board (IRB) initial applications, continuing review submissions, annual reports, protocol amendments and addendums, review and edit protocols, and informed consents
Prepare, negotiate, coordinate and track IRB review and documentation pertinent to the use of IRB reliance/master agreements for situations when performance sites rely on an IRB at another institution
Prepare and file study binder, "notes to study file" and communications log/file
File and maintain study case report forms
Maintain Investigator Curriculum Vitae & license requirements and all other regulatory documents as necessary
Maintain and report study subject tracking
Promote safety and confidentiality of research participants at all times
Act as coordinator for weekly research meeting, including updates of current and future research, minutes and reports as needed
Provide administrative support to investigators and research staff as needed
Monitor progress of research activities and develop and maintain records of research activities

What we offer

medical, dental, and vision healthcare
Flexible Spending Account
Health Savings account, with employer contribution
Coverage is provided for employees and family members including domestic partners
Short-and long-term disability
Employee Assistance Program
Life & ADD insurance
403b retirement plan with generous employer match
flexible leave options
11 paid holidays per year

Parttime

New

Quality Assurance Regulatory Affairs Coordinator

Location

United Kingdom , Oxford

Salary:

30000.00 - 40000.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Proactive and able to manage multiple priorities effectively
Comfortable working in a fast-paced, regulated environment
Excellent IT skills, ability to use MS Office and pick up bespoke systems with ease

Job Responsibility

Develop and deliver QARA training and inductions on core QMS processes, procedures, and requirements
Create and maintain training materials, ensuring accurate and up-to-date training records across the business
Provide administrative support to ensure regulatory affairs (RA) activities and timelines are effectively managed
Support the development, implementation, and continuous improvement of QARA strategies and the QMS
Ensure compliance with local, national, and international regulations, monitoring regulatory changes and assessing their impact

Fulltime

Quality Assurance Regulatory Affairs Coordinator

We are looking for a highly organised and proactive Quality Assurance Regulatory...

Location

United Kingdom , Oxford

Salary:

30000.00 - 40000.00 GBP / Year

360 Resourcing Solutions

Expiration Date

Until further notice

Requirements

Proactive and able to manage multiple priorities effectively
Comfortable working in a fast-paced, regulated environment
Excellent IT skills, ability to use MS Office and pick up bespoke systems with ease

Job Responsibility

Develop and deliver QARA training and inductions on core QMS processes, procedures, and requirements
Create and maintain training materials, ensuring accurate and up-to-date training records across the business
Provide administrative support to ensure regulatory affairs (RA) activities and timelines are effectively managed
Support the development, implementation, and continuous improvement of QARA strategies and the QMS
Ensure compliance with local, national, and international regulations, monitoring regulatory changes and assessing their impact

Fulltime

Senior Regulatory Affairs Consultant - Regulatory Intelligence

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

At least 5-7 years of regulatory affairs experience to include previous regulatory intelligence experience
Knowledge of FDA regulations as well as an understanding of the Summary basis of approval and labeling is helpful
A minimum of a bachelor’s degree in a scientific or technical discipline, advanced degree preferred
Project management / leadership experience
Excellent interpersonal and intercultural communication skills, both written and verbal
Client-focused approach to work (Quality)
Results orientation
Teamwork and collaboration skills
Consulting skills
Critical thinking and problem-solving skills

Job Responsibility

Regularly search the public domain for new and updated regulations and regulatory guidance documents that can impact the client’s development programs, and report the most critical findings
Regularly search the public domain for competitor product regulatory developments and report the most critical findings
Inform client immediately of any changes to the regulatory environment directly affecting client’s business
Search for non-compliance letters or notices for client’s suppliers and provide a regular report
Perform ad hoc research on specific regulatory topics at client’s request, using the internet and various subscription database tools
Identify public commenting opportunities for draft guidances/regulations and coordinate review and comments from client. Lead the client’s internal process to obtain and coordinate SME impact assessments/comments, facilitate comment collection/assimilation, and help develop company messaging to share either with PhRMA working groups or directly with Health Authorities.
Maintain a list of upcoming regulatory meetings/workshops/conferences pertinent to client
Support Regulatory Intelligence activities, including the use of Cortellis, Citeline, WebWatcher. This includes tracking, coordinating and participating in ad hoc searches as well as scheduled activities.

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Senior Regulatory Affairs Associate - France Local Regulatory Responsible Person

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

France , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a life science discipline
Minimum 5 years' experience in French Regulatory Affairs, with strong understanding of French and EU regulatory requirements
Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
Comprehensive lifecycle management expertise for French submissions
Experience with ANSM submission processes and requirements
Competence in labelling management (updates, mock-up review, and print release processes)
Medical device knowledge advantageous, but not essential
Familiarity with systems such as Veeva Vault
Excellent organizational, time management, and interpersonal skills in a global environment
Proven ability to work effectively both independently and in teams

Job Responsibility

Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities
Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations
Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure
Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams
Serve as primary interface with ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé), industry groups, and trade associations
Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations
Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
Monitor status of submitted regulatory activities and ensure timely completion
Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
Ensure timely submission of renewals and mandated post-approval applications

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Senior Regulatory Affairs Associate - Spain Local Regulatory Responsible Person

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

Spain , Madrid

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a life science discipline
Minimum 5 years' experience in Spanish Regulatory Affairs, with strong understanding of Spanish and EU regulatory requirements
Proven experience with multiple submission types: CP, MRP, DCP, and National procedures
Comprehensive lifecycle management expertise for Spanish submissions
Experience with AEMPS submission processes and requirements
Competence in labelling management (updates, mock-up review, and print release processes)
Medical device knowledge advantageous, but not essential
Familiarity with systems such as Veeva Vault
Excellent organizational, time management, and interpersonal skills in a global environment
Proven ability to work effectively both independently and in teams

Job Responsibility

Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities
Ensure strict compliance with local regulations and actively participate in policy activities with industry groups and trade associations
Act as RA representative in audits/inspections, ensuring readiness and timely CAPA closure
Monitor regulatory landscape changes and communicate requirements to Global Regulatory Affairs (GRA) and local teams
Serve as primary interface with AEMPS (Agencia Española de Medicamentos y Productos Sanitarios), industry groups, and trade associations
Lead in-country regulatory processes for licenses, partner regulatory licenses, and market access collaborations
Prepare and coordinate local-specific documentation (e.g., Module 1) to meet national submission requirements
Monitor status of submitted regulatory activities and ensure timely completion
Manage comprehensive lifecycle activities including variations, renewals, PSURs, and PIP submissions
Ensure timely submission of renewals and mandated post-approval applications

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Director Regulatory Affairs

As Director Regulatory Affairs you will report to the Chief Regulatory Affairs O...

Location

Sweden , Lund

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Education in the natural sciences space with an MSc degree in Pharmacy, Chemistry or similar
Ideally 10+ years’ experience in industry and 7+ years in Regulatory Affairs
Experience in preparing regulatory strategies/regulatory development plans, highlighting precedence, evaluation of special regulatory procedures, and risk/mitigation assessments
Experience with clinical trial submissions and approvals
Previous experience in a senior regulatory role, including health authority interactions, e.g. FDA and EMA meetings is required, and experience with BLA/MAA dossier preparation and submissions is desirable
In-depth understanding of regulations and guidelines governing all phases of drug development
Highly resourceful team-player, with the ability to be also extremely effective independently
Strategic mindset, innovative yet pragmatic/solution-oriented thinking, at the same time keen to also work in an operational role with attention to detail
Strong written and oral communication skills
comfortable communicating with and building relationships with various stakeholders including external partners and regulatory authorities.

Job Responsibility

Lead and contribute to regulatory strategies for assigned projects that expedite development, maximize the probability of success and mitigate risks
Play a hands-on role in planning, preparing and coordinating regulatory documents for submission to global health authorities as part of regulatory filings, such as CTAs/INDs, amendments, annual updates, paediatric investigation plans, orphan drug applications, fast track applications, responses to health authority information requests and BLAs/MAAs
Managing and leading the planning and preparation of meeting requests and meeting packages for health authority interactions for assigned projects
Provide primary regulatory review of applications and ensure that sections are well written, timely submitted and in compliance with internal and external standards
Provide regulatory leadership and guidance to cross-functional project teams and lead the development, strategy and execution of regulatory submission documents while working collaboratively with the project team including a variety of personnel and staff
Liase with internal QA and CMC teams ensuring regulatory requirements are consistently met across QA and manufacturing functions.

Fulltime

Senior Associate - Regulatory Affairs

Let’s do this. Let’s change the world. In this vital role you will assist the US...

Location

United States

Salary:

83974.90 - 113613.10 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Master’s degree
Bachelor’s degree and 2 years of Regulatory Affairs experience
Associate’s degree and 6 years of Regulatory Affairs experience
High school diploma / GED and 8 years of Regulatory Affairs experience

Job Responsibility

Assist US Regulatory Lead to support local regulatory activities (e.g. IND submissions and agency meetings)
Provide and maintain CTA/MA documentation support (e.g. initial filings, amendments, and periodic reports) in collaboration with US Regulatory Lead
Create and maintain product regulatory information and history documents through Amgen systems
Appropriately archive regulatory documents and agency communications
Collaborate with CRO’s / partners to support site initiation
Complete regulatory forms to support agency communications
Participate in GRT to support execution of regulatory strategy
Coordinate QC of regulatory documentation (e.g. briefing materials)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Assist in template development and maintenance

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Select Country

Regulatory Affairs Coordinator

Job Responsibility

Requirements

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