Regulatory Affairs Officer Job at Cranleigh STEM (South Wales)

Senior Regulatory Affairs Officer

We are seeking a detail-oriented and experienced Regulatory Affairs Officer to j...

Location

India , Harohalli

Salary:

60000.00 - 70000.00 INR / Month ▼

Randstad

Expiration Date

June 27, 2026

Requirements

Minimum of 3 years of core experience in Regulatory Affairs
Strictly Pharmaceutical background (Candidates from Hospital/Healthcare backgrounds will not be considered for this specific role)
Proven exposure to USFDA and CDSCO guidelines
In-depth knowledge of GMP (Good Manufacturing Practices)
Hands-on experience with ISO and HIPAA compliance standards
Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm) or a related life sciences field
Ability to work under tight deadlines (specifically for audit windows)
Strong analytical skills with a high degree of accuracy in documentation
Willingness to work in a high-intensity environment during scaling phases

Job Responsibility

Lead the preparation and management of documentation for imminent audits, including USFDA, CDSCO, ISO, and HIPAA
Ensure all processes align with Good Manufacturing Practices (GMP) and other pharmaceutical regulatory requirements
Oversee the application, renewal, and maintenance of all necessary organizational certifications
Act as a subject matter expert and provide technical guidance to junior team members/freshers within the regulatory department
Collaborate with the Head of Supply Chain to develop regulatory strategies that support the rapid scaling of the facility

Fulltime

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Regulatory Affairs Senior Officer

Reporting to the Head of Regulatory Filings, located in Jersey, you will be resp...

Location

Luxembourg , Luxembourg

Salary:

Not provided

Alter Domus

Expiration Date

Until further notice

Requirements

A minimum of 5 years of experience in Financial Services, with a minimum of 2 years in a Regulatory Compliance or Filings execution role
Solid technical knowledge and practical experience in operational regulatory compliance and filing requirements (not just strategic framework design)
Exceptional organizational skills and unwavering attention to detail are critical for register maintenance and filing accuracy
Proven track record of independently and accurately executing complex, repetitive compliance tasks and meeting strict deadlines
The ideal candidate must demonstrate a passion for continuous learning and professional development
Demonstrate clear, concise, and professional communication skills, especially in articulating data requirements and status updates to stakeholders
Strong practical analytical abilities to identify and resolve data discrepancies or filing issues quickly

Job Responsibility

Ensure the correct discharge of all regulatory processes, including all relevant regulatory notices, applications, and files
Execute the preparation, quality assurance and timely submission of regulatory filings, notices, and applications, ensuring all documentation is complete, accurate, and ready for review by the Head of Regulatory affairs (located in Jersey)
Assist the Head of Regulatory affairs in the maintenance of the centralized regulatory register, accurately tracking all incoming and outgoing regulatory notices, applications, and compliance activities
Ensure strict adherence to the global compliance framework developed by the Regulatory Affairs team, including following all defined processes, timelines, and reporting responsibilities
Maintain comprehensive, audit-ready files and supporting documentation for all regulatory submissions
Support the Regulatory Affairs team in implementing new processes, procedures, and systems related to regulatory filings and data management
Coordinate closely with internal stakeholders (Risk, Compliance, Legal, SMEs) to gather necessary data and sign-offs required for accurate regulatory submissions
Conduct internal checks and controls on submission data before final delivery to applicable sign-off

What we offer

Support for professional accreditations such as ACCA and study leave
Flexible arrangements, generous holidays, plus an additional day off for your birthday
Continuous mentoring along your career progression
Active sports, events and social committees across our offices
24/7 support available from our Employee Assistance Program
The opportunity to invest in our growth and success through our Employee Share Plan
Plus additional local benefits depending on your location

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

Head of Global Regulatory Affairs CMC

This position is responsible for defining and executing global regulatory strate...

Location

Italy , Bologna; Milan; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

15+ years of experience in regulatory affairs with strong focus on CMC
Deep expertise in global CMC regulatory requirements (FDA, EMA, ICH guidelines)
Proven leadership of global teams and complex regulatory programs
Demonstrated success in major filings and global product approvals
Advanced degree in chemistry, pharmacy, chemical engineering, or related scientific discipline (PhD preferred)
Strategic regulatory leadership and decision-making
Deep CMC scientific and technical expertise
Strong understanding of pharmaceutical manufacturing processes
Health authority interactions and relationship management
Proven ability to be hands-on, agile and lead organizational efforts and innovation by example

Job Responsibility

Define and lead global regulatory CMC strategies and execution for development, registration, and post-approval lifecycle management, leveraging frameworks such as RELIANCE where appropriate
Ensure alignment of CMC regulatory approaches with overall product development and commercialization strategies, partnering cross-functionally to ensure aligned approach
Provide strategic input into critical development milestones (e.g., IND/CTA, BLA/NDA, MAA)
Oversee the development of high-quality CMC regulatory dossiers, including Module 3 content and supporting documentation, including rigor in CMC regulatory justifications, control strategies, comparability, and specifications
Ensure alignment with ICH guidelines and evolving regulatory science expectations, proactively communicating these and their impact for Alfasigma across the organization
Lead regulatory support for manufacturing changes, site transfers, scale-ups, and technology transfers
Serve as the senior regulatory CMC representative in interactions with global health authorities (e.g., FDA, EMA)
Establish global frameworks for CMC change management, ensuring compliance and minimizing regulatory risk
Drive efficient handling of complex changes (e.g., process improvements, new technologies, dual sourcing)
Ensure global alignment and consistency across markets

What we offer

competitive salary
comprehensive benefits
extensive opportunities for professional growth and development

Fulltime

Regulatory Affairs Manager

Time for change – time for a new job! You are a regulatory affairs specialist an...

Location

Germany , Ludwigshafen am Rhein

Salary:

45000.00 - 60000.00 EUR / Year

Randstad

Expiration Date

June 30, 2026

Requirements

Bachelor's degree in life science, clinical research studies or engineering, ideally with previous regulatory experience
Several years of experience in a regulated business environment (e.g. legal office, regulated industry)
Experience working with Microsoft Office suite, most notably with Excel, Word, Outlook, Teams, and Microsoft SharePoint tools
Working knowledge of database management
Knowledge on current policies and practices issued by local German federal agencies
Awareness on regulatory policies/procedures to learn and better understand how the landscape of regulations develops
Good proficiency in the English language
Strong negotiation and communication skills as well as ability to organize data and identify issues or gaps in documentation

Fulltime

Regulatory Affairs Specialist I

We are looking for a detail-oriented individual to join our European Regulatory ...

Location

United Kingdom , Loughborough

Salary:

13.50 GBP / Hour

Randstad

Expiration Date

July 27, 2026

Requirements

A Bachelor's degree in Life Sciences, Chemistry, Pharmacy, Engineering, or a related scientific field is required
No prior professional experience is required
Strong technical writing and organizational abilities
High attention to detail and analytical thinking
Proficiency in Microsoft Office (Word, Excel, PowerPoint)
Effective communication skills in English
A collaborative team player who can also work independently to meet deadlines

Job Responsibility

Compile and maintain technical documentation for product registrations
Support product lifecycle management from initial registration through post-market activities
Collaborate with Quality Assurance, Supply Chain, and Customer Service teams to ensure compliance
Manage regulatory databases and submission systems
Review international regulatory requirements to support efficient product launches

Fulltime

Regulatory Affairs Consultant - CMC vax/bio (home or office based)

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

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

University-level education, preferably in Life Sciences, or equivalent by experience
Previous experience in regulatory affairs, particularly related to technical/CMC/quality, within the pharmaceutical industry
Strong understanding of CMC and post-approval regulatory requirements
Experience in writing CMC (technical) sections of regulatory documents such as registration files or variations
Knowledge of vaccines or biological processes - must
Background in validation/Quality Assurance/production in the pharmaceutical industry, with experience in preparing regulatory documentation
Understanding of qualification/validation principles
Proficiency in Word, PowerPoint, Excel, and experience with Veeva Vault is valued
Team spirit, flexibility, accountability, and organizational skills
Fluent in English (written and spoken)

Job Responsibility

Develop submission strategies and plans for post-approval CMC activities such as variations, renewals, market expansions, and annual reports
Assess change controls and provide regulatory assessments of quality changes in production and quality control
Review study reports from the quality control and production departments to ensure compliance with regulatory requirements
Coordinate submission preparation with various departments including manufacturing, supply chain, quality control and quality assurance, and other regulatory departments and local companies
Write and/or review submission content to ensure alignment with regulatory requirements, specifically related to variations and questions from health authorities
Manage projects within all Regulatory Information Management systems, ensuring the maintenance of worldwide submissions
Identify, escalate, and mitigate risks associated with regulatory procedures and activities

What we offer

Flexible work arrangements

Fulltime

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Regulatory Affairs Officer

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