CrawlJobs Logo
iconplc Logo iconplc · IT - Administration

Senior Regulatory Affairs Specialist

South Korea, Seoul Employment contract · Job Posted June 30, 2026
Apply Position
Job Link Share

Job Description

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. As a Senior Regulatory Affairs Specialist at ICON, you will ensure regulatory compliance and facilitate the successful execution of clinical trials, contributing to the advancement of innovative treatments and therapies.

Job Responsibility

  • Achieve timely & successful product registration in accordance with corporate & local strategies
  • Collect any information on new regulations and guidelines and share it in local RA team
  • Ensure compliance with company regulatory policies, regulations and procedures
  • Design and assess local regulatory plans including new strategic concepts and license opportunities and provide consolidated input on key regulatory development in cross-functional team meeting
  • Manage all regulatory tasks & projects including attaining, maintaining product licenses and operations licenses for assigned portfolio on behalf of company as required by local regulations
  • Prepare and submit regulatory applications for assigned portfolio and ensure timely approval
  • Develop local registration plans in alignment with local business and global regulatory strategy
  • Monitor progress of submission & coordinate timely responses to all questions from health authorities
  • Be compliant with Corporate Policies, Regulations & Procedures, in particular implementation of current Company Core Data Sheet (CCDS), Change Review Committee (CRC) and local change control procedures
  • Management of regulatory submissions to support clinical trial activities
  • Collect new or updated local regulations via various potential sources and keep local RA team informed
  • Ensure regulatory impact assessment in timely manner
  • Maintain close relationships with relevant health authorities and other organizations / key stakeholders
  • Communicate with Regulatory Authorities and local industry groups on regulatory issues
  • Provide regulatory consultation & collaborate with local business stakeholders
  • Participate in promotional material approval process
  • Provide feedback to global and participate in global initiatives when required
  • Timely submission of CCPS, CRC, Renewals, PSUR and other local validation in compliance with internal KPIs
  • Ensure regulatory database is up to date
  • Ensure timelines for regulatory review in e-MLR process are met and promotional materials comply with local regulations
  • Contribute to audits, CAPA process as appropriate and support local inspection readiness
  • Archiving of local regulatory submission documents

Requirements

  • Degree in Pharmacy preferred
  • +3 years of experience in pharmaceutical, medical device or health industry
  • Experience in regulatory affairs or relevant discipline is preferred
  • Solid understanding of drug development
  • Good knowledge of National Drug Regulations and Procedures
  • English Proficiency
  • Good communication skill for external and internal interaction
  • Good computer literacy skills, comfortable working with database

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
iconplc - All Job Offers

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Suggested Tags: Frontend Developer Secretary Talent Manager Salesforce Administrator Data Analyst
Similar Jobs for

Senior Regulatory Affairs Specialist

8 matching positions

Senior Regulatory Affairs Specialist

Location
Location
United States , St. Louis
Salary
Salary:
44.00 - 47.00 USD / Hour
bhsg.com Logo
Beacon Hill
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor Degree in scientific discipline required or equivalent work experience
  • 5 or more years of Regulatory experience or related field. RAC certification preferred
  • Cross functional interaction experience, coordinating activities, driving projects and initiatives to completion, and working to align communications with other departments is required
  • Project leadership or supervisory experience is preferred
  • Strong organizational skills, strong attention to detail, ability to problem solve and to work well with others and cross-functionally
  • Excellent written and oral communication skills
  • Use of software system to manage change controls
  • Strong background using Microsoft Office tools and Adobe Acrobat
  • Travel Time Required – up to 10%
Job Responsibility
Job Responsibility
  • Support of US FDA applications (NDAs, ANDAs, DMFs)
  • Plan/author/compile/submit statutory reports in eCTD format for marketed products per FDA requirements
  • Review, assess CMC regulatory impact and provide regulatory strategy for post-approval changes proposed at the manufacturing site
  • Act as the CMC regulatory lead to cross-functional teams on health authority requirements and preparation of information/technical data needed for support of post-approval changes
  • Author/compile/submit post-approval change supplements
  • Author/review updates to marketed product labeling
  • Maintain regulatory knowledge of current guidelines and regulations
  • Maintain current regulatory databases and produce various reports as needed
  • Utilize and support electronic document management system
  • Provides mentorship for entry-level and intermediate-level regulatory associates
Read More
Arrow Right

Senior Regulatory Affairs Specialist

Are you interested in the future of digital health and medical device innovation...
Location
Location
Denmark , Copenhagen
Salary
Salary:
Not provided
3shape.com Logo
3Shape
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree within natural sciences, computer science, engineering or similar
  • 5-10+ years in regulatory affairs (preferably both software and hardware medical devices)
  • Global regulatory market experience (e.g. EU, UK, Switzerland and MDSAP)
  • Demonstrated experience applying and interpreting relevant guidance and standards across software and hardware medical devices, including: IEC 60601 series, ISO 14971, IEC 62304, IEC 82304
  • Strong knowledge of cybersecurity and the evolving regulations for digital health and AI/ML devices
  • Adaptable and open to change and adjustments in agile work environments
  • Global mindset and experience with work relations in different cultures
Job Responsibility
Job Responsibility
  • Ensuring that regulatory requirements are in place for our innovative medical device software solutions and intraoral scanner portfolio incl. AI devices
  • Involved in development projects from the start, where your regulatory expertise will be needed as crucial input for the development and market release planning and registration of our devices
  • Ensuring global device registrations
  • Working closely with many stakeholders across R&D, Marketing, Product Management and sales offices around the globe as well as local external advisors and regulatory consultants
  • Active within advocacy and are involved externally in industry organizations and relevant forums influencing policy work and regulatory frameworks
What we offer
What we offer
  • An attractive healthcare package to keep you fit and well
  • Breakfast every day, and a delicious and healthy lunch cooked by our private chefs
  • Good work/life balance e.g., work from home policy for up to 2 days per week
  • Amazing location – our office is located in the heart of Copenhagen, right next to Kongens Nytorv
  • Social clubs, monthly Friday social activities, as well as various in-team activities
  • Fulltime
Read More
Arrow Right

Senior Regulatory Affairs Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...
Location
Location
Belgium , Mechelen
Salary
Salary:
Not provided
Cunesoft
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in Life Science
  • Several years experience, or demonstrable capability, in area of responsibility or similar field
  • advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks
  • Ability to deliver on customer or internal projects / processes within daily work
  • ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
  • Structured and systematic and independent way of working
  • limited latitude within established set of procedures, may determine priorities with little supervision
  • Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
  • Ability to train and support junior/new colleagues in daily activities
  • ability to lead small projects with clearly defined scope
Job Responsibility
Job Responsibility
  • Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead
  • Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products
  • Support with preparation, review and compilation of documents within the framework of regulatory affairs projects
  • Communicate with clients and Health Authorities in close cooperation with the respective lead
  • Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead
  • General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management
  • Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues
  • Support with strategy implementation and optimization
  • Comply with and support the maintenance of internal procedures
  • Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead
  • Fulltime
Read More
Arrow Right

Senior Regulatory Affairs Specialist

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...
Location
Location
Belgium , Mechelen; Brussels
Salary
Salary:
Not provided
cencora.com Logo
Cencora
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • University degree in Life Science
  • Several years experience, or demonstrable capability, in area of responsibility or similar field
  • advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks
  • Ability to deliver on customer or internal projects / processes within daily work
  • ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures
  • Structured and systematic and independent way of working
  • limited latitude within established set of procedures, may determine priorities with little supervision
  • Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
  • Ability to train and support junior/new colleagues in daily activities
  • ability to lead small projects with clearly defined scope
Job Responsibility
Job Responsibility
  • Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead
  • Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products
  • Support with preparation, review and compilation of documents within the framework of regulatory affairs projects
  • Communicate with clients and Health Authorities in close cooperation with the respective lead
  • Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead
  • General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management
  • Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues
  • Support with strategy implementation and optimization
  • Comply with and support the maintenance of internal procedures
  • Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead
  • Fulltime
Read More
Arrow Right

Senior Regulatory Affairs Specialist

Reporting to the Senior Manager, Regulatory Affairs within the RA Department, th...
Location
Location
United States , St Louis
Salary
Salary:
74000.00 - 90000.00 USD / Year
steris.com Logo
STERIS
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree
  • At least 5 years professional experience including regulatory affairs, quality systems, internal auditing, applicable scientific or technical functions
  • Self-starter with demonstrated organizational, project management, time management and problem-solving skills
  • Experience working effectively on cross-functional teams
  • Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
  • Excellent PC skills, including Microsoft Office applications including Excel, Word and PowerPoint
  • Understanding of chemical / scientific industry
  • Experience with internal audit process and quality systems
  • Experience with Healthcare regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries
Job Responsibility
Job Responsibility
  • Identify regulatory requirements for new products or product enhancements early in the product development cycle
  • Assure that product registration and maintenance fees are tracked and paid
  • Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims
  • Review product revision requests to assure compliance with regulatory requirements
  • Work on product teams to develop regulatory strategy based on regulatory submission requirements
  • Review and approve labeling and marketing literature
  • Support Manager, Regulatory Affairs and other Regulatory Affairs staff with all regulatory matters
  • Provide Regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries to the Healthcare team
  • Work with direct Supervisor and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management
  • Other duties as assigned
What we offer
What we offer
  • Market Competitive Pay
  • Extensive Paid Time Off and (9) added Holidays
  • Excellent Healthcare, Dental and Vision Benefits
  • Long/Short Term Disability Coverage
  • 401(k) with a company match
  • Maternity and Paternity Leave
  • Additional add-on benefits/discounts for programs such as Pet Insurance
  • Tuition Reimbursement and continued education programs
  • Excellent opportunities for advancement in a stable long-term care
  • Fulltime
Read More
Arrow Right

Senior Regulatory Affairs Specialist

New RA position dedicated to the Reusable Pen Platform and its 2 strategic custo...
Location
Location
United States , Franklin Lakes
Salary
Salary:
59.00 - 63.00 USD / Hour
gomillenniumsoft.com Logo
MillenniumSoft Inc
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum of 5 years of directly related work experience in medical device regulatory field (regulatory submissions, compliance, project management)
  • Medical device and international registration experience is a must
  • Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint
  • Strong project management and communication (verbal, written) and skills
  • Able to independently handle multiple tasks/projects with minimum supervision
  • Self-starter with the ability to take over responsibilities
  • Team player, Attention to details, Highly result-oriented
  • Flexible and reliable personality
  • ability to manage stressful situations
  • High personal integrity and ethical standards
Job Responsibility
Job Responsibility
  • Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager
  • Manage and execute end to end activities, such as documentations, submissions and addressing health authority questions for new or renewal of existing medical device registrations of Reusable Pen and pen needles in worldwide market
  • Maintenance of compliant regulatory files and supporting documentation (EU technical files/ US master files/international technical dossiers) in WW market
  • Performs regulatory impact assessment of changes related to design, improvements and customer experience and coordination of supplement/notification/change submissions for timely implementation
  • Effective Collaboration with multiple stakeholders i.e. internal teams (PS cross functional, BDX), customers (consultants, pharma partners) and regulators (EU Notified Body, Health Canada, FDA) for technical requirements and documentation to support regulatory registrations, project deliverables and audit ready folders
  • Manages multiple projects with attention to detail for health authority submissions and represent RA in internal and external audits by customers and health authorities for compliance to MDSAP, EUMDR, ISO 13485 and global compliance
  • Identify ways to improve the efficiency of current work process and best practices as necessary.
What we offer
What we offer
  • You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture and life balance components — is designed to support the varying needs of our diverse associates.
  • Fulltime
Read More
Arrow Right

Senior Specialist, Regulatory Affairs

At Baxter, we believe every person—regardless of who they are or where they are ...
Location
Location
United States , Deerfield
Salary
Salary:
88000.00 - 121000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in a scientific, life sciences, or related technical field
  • 2+ years of regulatory experience
  • Strong understanding of Veeva software (RIM and Promo Mats) systems
  • Strong written and verbal communication skills, ability to organize, prioritize and meet deadlines
  • Strong analytical skills, including digital competency
  • Strong technical systems skills (i.e. databases, XML and Microsoft Office 365 including SharePoint, Power Automate and Excel)
  • Proofreading and editing skills
  • Ability to contribute to multiple projects from a regulatory affairs perspective
  • Ability to multitask and problem solve
Job Responsibility
Job Responsibility
  • Under general supervision, responsible for Veeva RIM, Promo Mats system ownership
  • Perform Veeva RIM business admin activities, including managing data, updates to system and participate in data governance activities
  • Working with project teams on various data initiatives, addressing data challenges and gaps in current system
  • Identify areas for improvement/modification
  • Compile regulatory documents for FDA 2253 submission. Which includes tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying aware of regulatory requirements
  • Develop training material and liaise with cross function teams
  • Understand internal global processes supporting Regulatory systems
  • Coordinates and drives deliverable preparation
  • develops and maintains process models using standard methods and tools
  • manages and tracks communications, metrics, and reporting-related processes
What we offer
What we offer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Educational assistance programs
  • Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • Fulltime
Read More
Arrow Right

Senior Specialist, Regulatory Affairs

The Senior Specialist resides within the Global Regulatory Affairs Systems Group...
Location
Location
United States , Deerfield
Salary
Salary:
88000.00 - 121000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's degree in a scientific, life sciences, or related technical field
  • 2+ years of regulatory experience
  • Strong understanding of Veeva software (RIM and Promo Mats) systems
  • Strong written and verbal communication skills, ability to organize, prioritize and meet deadlines
  • Strong analytical skills, including digital competency
  • Strong technical systems skills (i.e. databases, XML and Microsoft Office 365 including SharePoint, Power Automate and Excel)
  • Proofreading and editing skills
  • Ability to contribute to multiple projects from a regulatory affairs perspective
  • Ability to multitask and problem solve
  • Applicants must be authorized to work for any employer in the U.S.
Job Responsibility
Job Responsibility
  • Perform Veeva RIM business admin activities, including managing data, updates to system and participate in data governance activities
  • Working with project teams on various data initiatives, addressing data challenges and gaps in current system
  • Identify areas for improvement/modification
  • Compile regulatory documents for FDA 2253 submission
  • Develop training material and liaise with cross function teams
  • Understand internal global processes supporting Regulatory systems
  • Coordinates and drives deliverable preparation
  • develops and maintains process models using standard methods and tools
  • manages and tracks communications, metrics, and reporting-related processes
  • Develops, executes and implements business processes for data integration, maintenance and remediation
What we offer
What we offer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Educational assistance programs
  • Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • Fulltime
Read More
Arrow Right