Regulatory Affairs Associate Job at Solomon Page (Clark)

Regulatory Affairs Associate

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

A Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline
At least 3 years of experience or understanding of clinical regulatory Affairs requirements and activities such as IND Submission and CMC process professionals
Fluency in the local language and English is essential

Job Responsibility

Efficiently Drive Study Initiation: Conduct feasibility assessments, site identification, site contract negotiation, and other critical SSU activities
Empower Success through Specialized SSU Expertise: Provide expertise to Study Start Up team leads and project teams, providing valuable insights to drive success
Ensuring Regulatory Compliance: Prepare and coordinate submissions to regulatory, ethics, and other relevant bodies, ensuring compliance with all necessary regulations and guidelines
Safeguarding Patient Welfare: Contribute to the development, finalization, and review of Master and Country Specific Subject Information Sheets/Informed Consent Forms, guaranteeing the highest standards of patient safety and informed consent

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

Regulatory Affairs Associate

CK Group are recruiting for a Regulatory Affairs Associate to join a leading glo...

Location

United Kingdom , Reading

Salary:

25.00 GBP / Hour

CK Group

Expiration Date

Until further notice

Requirements

Hold a relevant scientific degree or have equivalent working experience
Good knowledge and experience of UK regulations
Previous working experience in pharmaceutical regulatory affairs
Ability and experience to work cross-functionally with different functions involved: Global functions, QA, PV, Marketing
Excellent communication skills

Job Responsibility

Support and maintain pharmaceutical product portfolios
Manage ongoing product information updates
Supports regulatory project plan execution
Assist in the preparation and review of labelling and local SOPs
Compile regulatory documents for submission

Fulltime

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

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

Senior Regulatory Affairs Associate - Clinical Trial Applications (CTA)

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

Location

South Africa , Bloemfontein

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University degree in a science discipline
Background in clinical trial management
Innitial years of Regulatory Affairs experience working with Clinical Trail Applications in South Africa - must
Experience with clinical trial submissions in other Southern African Countries - preferred
Good level of knowledge of the CTA business in addition, an expertise/skill in cross-functional project management and planning, process optimization
IT knowledge (Veeva Regulatory and Clinical Vaults - excel – VBA – powerBI)
Solid analysis and synthesis capability
Solution-oriented and problem-solving skills
Customer-oriented and autonomous
Fluency in English is a must along with the local language.

Job Responsibility

Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead
Regulatory submission of Clinical Trial in South Africa
Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary
May be involved in local, regional, and/or global projects

Fulltime

Sr Associate Regulatory Affairs

The Senior Associate in Regulatory Affairs supports country regulatory activitie...

Location

Czech Republic , Prague

Salary:

742975.65 - 1005202.35 CZK / Year

Amgen

Expiration Date

Until further notice

Requirements

Proficiency in English at B2 level or higher, proficiency in Czech
Basic understanding of regulatory principles
Ability to follow policies, procedures, and SOPs
Teamwork and communication skills
Willingness to learn and develop expertise
Bachelor's degree in a life-science area
Entry-level professional knowledge and/or experience in life-science sector (pharmacy, laboratory, public institution, academia)

Job Responsibility

Participates in preparing the filing plan (MA and lifecycle maintenance) and joins discussions with the local cross-functional team
Contributes to the execution of the filing plan (MA and lifecycle maintenance) for their country(ies) under supervision
Helps prepare regulatory submissions to ensure they are completed on time and meet Amgen's corporate and local regulatory requirements
Assists in preparing and reviewing source text for country labeling and preparation of country artwork based on source text
Supports assigned clinical study activities in collaboration with Regional and Global Study Operations (GSO)
Assists in reviewing simple promotional and non-promotional materials
Supports regulatory product compliance activities
Assists in communicating with regulatory agencies to help fulfill local obligations
Helps the team prepare for participation in local agency interactions
Assists cross-functional colleagues under supervision to help achieve team goals

Fulltime

Sr Associate Regulatory Affairs - CMC

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

Location

United Kingdom , Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Background in CMC related functions (e.g., Quality, Manufacturing, etc) with limited or no prior Regulatory Affairs experience
Curious, proactive, confident in tackling new challenges, and comfortable working collaboratively in a fast-paced learning environment
Developed project management and organizational skills
Strong and effective oral and written communication skills

Job Responsibility

Contribute as a key member of the global regulatory CMC product team
Interact with authors/reviewers and subject matter experts with respect to delivery of regulatory documents required for regulatory submissions
Contribute to the organization and preparation of CMC investigational product amendments, post‑market supplements/variations, and new marketing applications
Document and archive CMC submissions and related communications in the document management system
Initiate and maintain CMC product timelines at the direction of product lead
Interface with the regulatory operations team
Train staff on select CMC procedures and systems
Provide report status of activities and projects to teams and department
Participate in cross-functional special project teams

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

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Regulatory Affairs Associate

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