Regulatory Affairs Specialist I Job at Randstad (Loughborough)

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Senior 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

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

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

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

Are you a tech-savvy scientist with a passion for food law and innovation? A lea...

Location

Belgium , Leuven

Salary:

Not provided

Randstad

Expiration Date

September 06, 2026

Requirements

Undergraduate or Master’s degree in a relevant scientific or technical field, including coursework or exposure to food law
A minimum of 3 years in an SRA or R&D role, with hands-on experience working with legislation and its commercial application
Strong understanding of Global Food Law (interpretation and application)
Ideally possesses laboratory experience interpreting scientific data and technical reports
A background in nutrition, novel food regulations, or GRAS frameworks—particularly regarding functional ingredients, safety assessments, and health claims—is a major plus
Exceptional communication and influencing skills, a proven track record of perseverance and agility, and the ability to work under pressure against tight deadlines
Full fluency in English is required (other languages are an advantage)
Willingness to travel globally up to 20% of the time

Job Responsibility

Provide Global Regulatory Advice: Deliver expert guidance that optimizes commercial opportunities across multiple international markets while preserving the company’s reputation
Support Innovation & Tech Projects: Lead SRA insights for complex, high-priority commercial and technical projects, ensuring they meet business demands on time and within budget
Bridge Cross-Functional Teams: Promote synergies across global zones, connecting technical, marketing, and legal teams to develop compliant yet competitive business solutions
Analyze Market Trends & Science: Monitor consumer insights, emerging science, and competitor strategies to translate global regulatory assessments into actionable business scenarios for stakeholders
Leverage Global Networks: Work closely with the wider SRA network to optimize ways of working and deliver consistent, integrated recommendations

Fulltime

Senior Regulatory Affairs Specialist

Location

United States , St. Louis

Salary:

44.00 - 47.00 USD / Hour

Beacon Hill

Expiration Date

Until further notice

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

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

Regulatory Affairs Specialist

A Specialist profile will ensure efficient project execution, better quality out...

Location

India

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s or higher degree in a science related field, or equivalent experience
7-8 years of EU RA technical and project management experience
Good English language and grammar skills (written fluency a must, verbal fluency preferred)
Good computer skills and the ability to learn appropriate software
Good understanding of regulatory tracking database software, MS Word, MS Excel, MS PowerPoint etc.
Excellent organizational and interpersonal skills
Ability to work well within a team

Job Responsibility

Contribute to regulatory activities performed on the RA Platform/the Hub
Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers
To contribute to the production of client administrative documents and reports to be included in regulatory submissions
Support for Initial MA application, all kind of LCM activities
Act as (Single) Point of Contact and oversee clients’ portfolios
Cross-functional co-ordination
Communication with external vendors
Communication/Co-ordination with client and participate in client’s meeting, preparing MoM etc
Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements
Systems Management and Administration

Fulltime

Senior Specialist, Regulatory Affairs

At Baxter, we believe every person—regardless of who they are or where they are ...

Location

United States , Deerfield

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

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

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

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

Senior Specialist, Regulatory Affairs

The Senior Specialist resides within the Global Regulatory Affairs Systems Group...

Location

United States , Deerfield

Salary:

88000.00 - 121000.00 USD / Year

Baxter

Expiration Date

Until further notice

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

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

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

Group Regulatory Affairs Specialist Class II

At Ontex, we are making everyday life easier across generations. Worldwide our 5...

Location

Germany , Grosspostwitz

Salary:

Not provided

Ontex Peninsular

Expiration Date

Until further notice

Requirements

Master’s degree (university or equal through experience) in science
In-depth knowledge of US and Canada regulations, standards, and guidance documents for medical devices
Knowledge of quality management systems and medical device standards such as ISO 13485, ISO 14971
Minimum of 3 years experience in Regulatory Affairs for medical devices
Experience in 510k submission
Experience or interest in regulatory affairs for Software as Medical Device (SAMD)
Experience in working with cross-functional teams and building strong relationships across departments
Ability to integrate and demonstrate core values, integrity and accountability throughout the organization and externally
Ability to lead, manage, collaborate and communicate within the organization, with groups engaged in the development of good regulatory practice and policy, and within the regulatory profession

Job Responsibility

Researches and determines requirements for regulatory submissions, approval pathways and compliance activities
Monitor and evaluate the regulatory environment and provide internal advice
Supervises data input activities and provides impact analysis
Identifies the need for new regulatory procedures and SOPs
Identifies requirements for market access and distribution
Evaluates proposed preclinical, clinical and manufacturing documents for regulatory filing
Actively contribute in assessing the impact of new guidance and regulations
Provides regulatory input and technical guidance on global regulatory requirements
Advises stakeholders of regulatory requirements for quality, preclinical and clinical data
Works with cross-functional teams for interactions with regulatory authorities

What we offer

Permanent employment contract in a future-proof company bound by collective agreements
Attractive remuneration and comprehensive social benefits
Holiday and Christmas bonuses
30 days of holiday
Company pension scheme
Corporate benefits and discounts
Exciting and varied working environment

Fulltime

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

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Regulatory Affairs Specialist I

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