Regulatory Affairs Specialist Job at Randstad (Leuven)

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 Specialist

PLG is seeking a motivated and detail‑oriented Regulatory Affairs Specialist to ...

Location

Romania

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Degree in a relevant life science discipline (Pharmacy, Biology, Chemistry, or similar)
Minimum 5 years of relevant Regulatory Affairs experience
Strong experience in Romanian Regulatory Affairs
Proven experience across Product Lifecycle Management, including: New MAAs
Variations
Orphan Drugs
Line extensions
Product Information updates
Artwork review
Experience interacting with Health Authorities

Job Responsibility

Prepare, compile, and submit Marketing Authorisation Applications (MAA), including new MAAs and variations, for Romania and assigned EU countries
Support Orphan Drugs, line extensions, and launch readiness activities
Contribute to registration strategies and timelines in collaboration with PLG project teams and clients
Manage post-approval activities, including: Variations, Renewals, Product Information (SmPC, PIL, Labelling), Artwork review and updates
Ensure compliance with approved documentation throughout the lifecycle of assigned products
Monitor and maintain up-to-date knowledge of national (Romanian) and European regulatory requirements and legislation
Ensure full compliance with Regulatory processes, Assigned country regulations, Client-specific procedures
Ensure readiness for internal and external audits
Effectively manage Non-Conformities (NCs) and CAPAs in a timely manner
Act as a key contact with Health Authorities, ensuring effective and professional communication

Fulltime

Regulatory Affairs Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

South Korea , Seoul

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in a scientific or healthcare-related field
advanced degree preferred
Minimum of 2-3 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry
Proficiency in regulatory submission processes and requirements, including CT/IND, MAA/NA, variations, DSUR, PSUR, and renewals
Familiarity with label review, translation requirements, and regulatory intelligence activities
Strong attention to detail and excellent communication skills

Job Responsibility

Undertaking variable duties based on project requirements, primarily within Pharmaceutical, Biotechnology, or Biologics Regulatory Affairs, with potential involvement in related areas
Contributing to regulatory submissions team activities, including preparation, compilation, and submission of regulatory documents such as CT/IND, MAA/NA, variations/lifecycle submissions, DSUR, PSUR, renewals, and agency briefing documentation
Managing and implementing label review, translation requirements, fee calculations, and other aspects for regulatory submissions
Providing input to the Regulatory Intelligence function and participating in readability testing
Reviewing IMPD/IB Core Docs and labeling for clinical trials
Collaborating with Regulatory Submissions team or cross-functional teams based on project size and nature
Facilitating business development activities as needed

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 Specialist

PLG is seeking a motivated and detail-oriented Regulatory Affairs Specialist to ...

Location

Poland

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Master’s degree or higher is a plus)
5-10 years of relevant experience in Regulatory Affairs, focusing on Polish markets
Proven experience in the lifecycle maintenance of medical products
Hands-on experience with Marketing Authorization Applications (MAA), Common Technical Documents (CTD), product labeling, Orphan Drugs, Line extensions, Product Information updates, Artwork review
Strong familiarity with European Regulatory Authorities and international regulatory frameworks
Proficiency in regulatory software packages and databases, such as Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat, etc.
Fluent in English and Polish, with excellent communication skills—both written and verbal, proficiency in additional languages is a plus
Excellent organizational skills with the ability to prioritize tasks and deliver high-quality work in a fast-paced environment

Job Responsibility

Prepare and submit Manufacturing License Applications (MLA) for new products and site transfers
Lead the preparation and submission of Marketing Authorization Applications (MAA) across Polish and global markets
Support Technical/Site Transfer Applications for product launches and changes
Manage post-approval regulatory processes, including Variations, Renewals, and Marketing Authorization Holder (MAH) Transfers/Certificates of Analysis (COA)
Handle updates to product Labeling, Line extensions, Product Information, Artwork, and ensure compliance with approved documentation
Continuously monitor and maintain up-to-date knowledge of national, European, and international regulatory guidelines and legislation
Ensure strict compliance with regulatory requirements and readiness for both internal and external audits
Serve as a key liaison between our company and regulatory authorities, facilitating clear communication and timely submissions
Respond to internal inquiries and provide regulatory support to cross-functional teams
Use a variety of software packages to create correspondence, prepare documents, maintain spreadsheets, and manage databases (e.g., Microsoft Office Suite, Veeva Vault, or comparable EDMS, LorenZ, Trackwise, PromoMat)

Fulltime

Regulatory Affairs Specialist

PLG is seeking a motivated and detail-oriented Regulatory Affairs Specialist to ...

Location

India

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Life Sciences, Pharmacy, or a related field (Master’s degree is a plus)
3–7 years of experience in Regulatory Affairs, with exposure to UK and EU regulatory environments
Experience supporting lifecycle maintenance of medicinal products
Hands‑on experience with MAA support activities, CTD/eCTD, product labelling, line extensions, Product Information updates, and artwork review
Good understanding of MHRA and EMA procedures and post‑approval regulatory requirements
Experience working with regulatory systems and databases (Microsoft Office, Veeva Vault or similar EDMS, LorenZ, Trackwise, PromoMats)
Fluent in English (written and spoken)
additional EU languages are a plus
Strong organisational skills and ability to manage multiple priorities in a dynamic environment

Job Responsibility

Prepare and submit Manufacturing Licence Applications (MLA) for new products and site transfers in the UK and EU
Support and contribute to the preparation and submission of Marketing Authorisation Applications (MAA) via UK national, MRP/DCP, and EU procedures
Support Technical and Site Transfer Applications related to product launches, manufacturing changes, and regulatory updates
Assist with CTD/eCTD dossier preparation, compilation, and lifecycle management in accordance with MHRA and EMA requirements
Manage post‑approval regulatory activities, including Variations, Renewals, Line Extensions, and MAH Transfers, across UK and EU markets
Maintain approved Marketing Authorisations throughout the product lifecycle, ensuring timely and compliant submissions
Handle updates to Product Information (SmPC, PIL, labelling), artwork, and packaging, ensuring alignment with approved documentation and regulatory standards
Monitor and interpret UK and EU regulatory legislation, guidelines, and regulatory intelligence updates
Ensure compliance with UK Human Medicines Regulations and EU regulatory frameworks
Support inspection and audit readiness (internal and external) by maintaining compliant regulatory documentation

Fulltime

Regulatory Affairs Specialist

CK Group is recruiting for a Regulatory Affairs Specialist to join a company in ...

Location

United Kingdom , Reading

Salary:

63.52 - 86.22 GBP / Hour

CK Group

Expiration Date

Until further notice

Requirements

Relevant Bachelor's Degree or higher in Life Sciences, Chemistry, or Pharmacy
Expertise across a broad spectrum of Regulatory classifications, but must have experience in cosmetics
Oral care experience is preferred, but broader cosmetics will also be considered
Strong knowledge of regulatory strategy and compliance, and the ability to apply these to regulatory solutions throughout the product lifecycle
Solid understanding of regulatory/medical/safety/quality requirements

Job Responsibility

Ensures the success of new product registrations, line extensions and new indications and claims in alignment with the business plan
Manages the coordination, compilation, and submission of new drug applications and cosmetics to the regulatory agencies within their geographical and/or brand area of responsibility
Maintains compliance for all products with local regulations and quality system requirements

Regulatory Affairs Specialist

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, ...

Location

United States , Saint Paul

Salary:

Not provided

Hemostasis Corp

Expiration Date

Until further notice

Requirements

Master’s degree in Regulatory Affairs and Services
Excellent written and oral communication skills
Demonstrate proactive and strategic thinking and be able to handle change and ambiguity

Job Responsibility

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review
Provide technical review of data or reports that will be incorporated into regulatory submissions
Analyze validation test data to determine whether systems or processes have met validation criteria
Study product characteristics or customer requirements and confer with management to determine validation objectives and standards
Identify deviations from established product or process standards and provide recommendations for resolving deviations
Develop validation master plans, process flow diagrams, test cases, and standard operating procedures
Create, populate and maintain the database for tracking validation activities, test results and validation systems
Prepare, maintain, and review validation and compliance documentation such as engineering change notices, schematics, and technical files to obtain and sustain product approval
Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements
Prepare additional information or responses as requested by regulatory agencies

What we offer

401K
Dental
Life
Medical
Disability
Competitive salary and benefits package including health, life, retirement and related benefits

Fulltime

Regulatory Affairs Specialist

Join a top-tier global healthcare leader with a stable, inclusive, and professio...

Location

Japan , Tokyo

Salary:

4000000.00 - 8000000.00 JPY / Year

Randstad

Expiration Date

November 30, 2026

Requirements

Strong English and Japanese communication skills (written and verbal)
Experience in Regulatory Affairs for IVD or Medical Devices
typically 2+ years preferred, but equivalent experience considered
Ability to collaborate effectively with cross-functional teams
Understanding of regulatory requirements for IVD/Medical Devices
Basic understanding of ISO 13485 and global QMS principles
High attention to detail and strong documentation management skills

Job Responsibility

Work as a Legal Manufacturer RA, driving global market access directly from Japan
Engage in cross-border projects using English daily within a dynamic factory RA team

What we offer

健康保険
厚生年金保険
雇用保険
土曜日
日曜日
祝日

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