Veeva RIM Project Manager Job at Proclinical (Surrey Heath)

Senior Associate Data Management

The Senior Associate, Data Management, will help drive key business operation in...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance
In depth understanding of the Veeva Vault system
Good written and verbal communication skills
Detail oriented
Independent time management and prioritization skills
Work efficiently with little support and minimal to no supervision
Ability to work well with others in demanding situations with a positive attitude demonstrating tact, diplomacy, and respect
Critical thinking skills
Appropriate software skills as required
Strong analytical and problem solving, communication and presentation skills

Job Responsibility

Responsible for maintaining data within the Regulatory Information Management (RIM) system
Create and archive clinical trial, marketing application submissions and health Authority correspondence within Amgen’s RIM system
Serve as a Data Management SME within cross-functional collaborative initiatives
Deliver the implementation of new processes within Veeva Vault, XeVMPD, IDMP and other key regulatory initiatives, ensuring alignment with global regulatory standards and business objectives
Provide support on creating, running and analysing reports for data streamline projects
Develop and deliver training materials and presentations to a global audience
Manage the protocol Amendment New Investigator (PANI) submission updates
Manage 1572 forms for FDA submission
Provide support within the global data management team on US Certificate of Pharmaceutical Product (CPP) and EU Certificate of Medicinal Product (CMP) during additional workload periods
Adhere to Amgen processes, policies, guidelines, SOPs and training documentations

What we offer

Competitive and comprehensive Total Rewards Plans aligned with local industry standards

Regulatory Affairs Training Manager

SRG are looking for RA training manager to join a global pharmaceutical company ...

Location

United Kingdom , White City, London

Salary:

Not provided

SRG

Expiration Date

Until further notice

Requirements

Life Science Degree or other University degree with equivalent experience
Strong training, communications, project management skills
Experience in Project management tools & systems
Proven successful experience on the design and development of training concepts with cross-functional teams
Strong training delivery capability
Good understanding and direct experience with Veeva RIM deployments
Good understanding of all RA roles
Good Organizational awareness
Technology-savvy - ability to leverage and use systems, technology and automation to (including digital assistants and AI tools) to derive impactful trainings and communications
Strong communication skills

Job Responsibility

Review and validate central Training material related to Veeva RIM platform deployment
Create any local Function-specific materials as required, especially for Super Users
Ensure training materials are regularly updated for program changes (incl. Job aids, e-learnings, etc)
Set up any mandatory e-Learning content training in Up4Growth for training push
Customize Training communications material from Central Training team to provide proactive information and regular updates
Contribute to creating and delivering Function-specific Training communications and materials as necessary, in line with agreed central governance processes
Support coordination and promotion of Show & Tell/ demo sessions within Function
Attend central Train the Trainer sessions
Schedule Super User training sessions in Up4Growth
Deliver Training sessions

Fulltime

Senior Regulatory Consultant - Regulatory Project/Program Manager

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

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

BA/BS degree in a scientific, engineering, or healthcare discipline required
advanced degree (MS, PharmD, PhD) and/or PMP certification strongly preferred
Minimum of 7 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with at least 5 years in regulatory or regulatory program management
Proven ability to partner on regulatory strategy and lead execution across all stages of product development, including IND/BLA/MAA submissions, global registration, and post-marketing activities
Deep understanding of U.S. regulatory requirements with working knowledge of international (ex-U.S.) regulations and agency expectations
Demonstrated success managing complex regulatory deliverables across cross-functional teams within a matrixed organization, while maintaining alignment to strategic priorities
Hands-on experience with eCTD and a strong command of regulatory documentation, formatting, and submission strategy
Exceptional communication and influencing skills, with the ability to synthesize complex regulatory information and translate it into clear recommendations for senior leadership and global stakeholders
Strong judgment and agility in managing competing priorities, resource constraints, and evolving program needs with flexibility and strategic foresight
Demonstrated ability to leverage project management tools and best practices to enhance visibility, efficiency, cross-functional alignment, and meeting effectiveness across GRSTs and project teams

Job Responsibility

Partner strategically with Global Regulatory Leads to shape and execute forward-looking, globally aligned regulatory plans across all stages of development and post-marketing
Translate regulatory strategy into integrated, actionable plans with clear milestones, critical paths, risks, and opportunities to support effective planning and decision-making
Lead the execution of regulatory plans, ensuring alignment between day-to-day operations and broader strategic objectives across global programs
Identify and propose innovative regulatory pathways and planning scenarios that align with global regulatory expectations and business objectives
Collaborate closely with cross-functional teams and senior leadership to drive clarity, alignment, and accountability for regulatory deliverables, timelines, and interdependencies
Facilitate Global Regulatory Subteam (GRST) meetings and other routine and ad hoc project review forums, ensuring meetings are purpose-driven, well-structured, and focused on decision-making, risk mitigation, and regulatory execution
Apply project management best practices for meeting management and hygiene, including developing and distributing agendas in advance, defining objectives and discussion topics, maintaining action logs, documenting key decisions and next steps, tracking follow-up items to closure, and ensuring materials are stored and communicated appropriately
Partner with Global Regulatory Leads and cross-functional stakeholders to maintain effective GRST governance, meeting cadence, stakeholder alignment, and communication flow across global and regional teams
Anticipate and troubleshoot complex regulatory project and operational challenges, implementing scalable solutions that strengthen team effectiveness, process efficiency, and submission readiness
Prepare and deliver strategic dashboards, reports, and scenario plans to senior stakeholders, translating regulatory progress and risks into actionable business insights

What we offer

Flexibility of working remotely
Supportive and dynamic team
Challenging assignments
Mentorship from experienced regulatory professionals
Opportunities for career growth
Diverse and global client exposure
Learn from experts
Flexible work arrangements

Fulltime

Regulatory Affairs Generalist

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 Degree in a Scientific or Technical Discipline
A few years of experience in an industry-related environment
Experience in regulatory authority-facing roles
Regulatory Operations (Submission management) experience
Experience using Veeva Vault RIMS - strong plus
Outstanding interpersonal and intercultural communication skills (written and verbal)
Critical thinking and problem-solving abilities
Fluent in English, written and spoken

Job Responsibility

Support global and/or local regulatory teams with comprehensive understanding of regional and global regulatory requirements
Manage post-authorization lifecycle maintenance procedures (variations, renewals, PSURs) for multiple licenses
Coordinate health authority interactions and responses to questions
Prepare and organize local-specific documentation (Module 1) to meet national submission requirements
Maintain up-to-date local national systems according to local legislation
Manage impact assessments for technical changes affecting marketing authorizations
Stay current on regulatory requirements and guidelines to ensure compliance
Support health authority inspections as needed
Provide technical and business consulting services within area of expertise
Complete activities within project scope, timeline, and objectives

What we offer

Flexible work arrangements
Opportunities for career growth
Supportive and inclusive environment
Diverse and global client exposure
Learn from experts

Senior Global CMC Manager (Development & Lifecycle)

Karo Healthcare, a dynamic and growing personal-care retail company, is all abou...

Location

Sweden , Stockholm

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

University degree in Life Sciences
Strong understanding of regulatory requirements and applicable legal frameworks for pharmaceutical products
Proven CMC expertise covering the full product lifecycle, including post-approval development and manufacturing-related changes
Extensive experience in variation management, including the development and execution of regulatory and CMC strategies
Experience with EU regulatory procedures (primarily national, as well as DCP and MRP), with exposure to additional markets considered an advantage
Demonstrated experience working at the interface between Regulatory CMC, R&D CMC, and Manufacturing for commercialised pharmaceutical products
Hands-on experience with CMC Module 3 authoring, review, and lifecycle maintenance
Solid understanding of pharmaceutical manufacturing processes, formulation principles, APIs, and CMO-based supply models
Proven ability to work cross-functionally with Regulatory Affairs, Quality, Manufacturing, Supply Chain, Commercial functions, and external partners
Experience interacting with regulatory authorities and maintaining effective professional relationships

Job Responsibility

Act as global CMC Module 3 owner throughout the product lifecycle, ensuring scientific consistency and alignment with the actual manufacturing processes, formulation, APIs, control strategies, and implemented post-approval changes
Manage and maintain the CMC (Module 3) components of global and local dossiers, including technical preparation and compilation of CMC documentation to support regulatory submissions and lifecycle maintenance, with particular responsibility for legacy products
Ensure timely implementation of approved CMC changes within defined scope, including verification that Module 3 documentation and internal systems reflect Health Authority approvals
Assess and lead regulatory CMC evaluation of proposed changes, including technical impact assessment, variation classification, and identification of required documentation in alignment with applicable EU and relevant market requirements
Review and approve regulatory CMC documentation for submissions and lifecycle changes in compliance with applicable regulatory requirements and internal regulatory information and document management systems
Initiate and maintain CMC-related regulatory events and documentation within the regulatory information management system (e.g., Veeva RIM) in accordance with internal procedures
Maintain a current understanding of relevant CMC-related regulations, guidelines, and standards, as well as established and emerging manufacturing and development practices applicable to commercialised pharmaceutical products
Lead CMC strategy development for assigned products across development and lifecycle phases, providing aligned CMC input to regulatory strategy discussions, technical risk assessments, gap analyses, and the evaluation and implementation of lifecycle changes
Apply in-depth knowledge of CMC Module 3 as a practical lifecycle tool to support and drive technical and regulatory decision-making related to manufacturing and post-approval development activities
Act as a technical and regulatory CMC counterpart towards manufacturing CMOs, developing a sound understanding of their manufacturing operations and providing appropriate scientific input, guidance, and challenge as required

What we offer

Opportunity to create, grow, and encourage
Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
Very positive work environment in a dynamic, international, and motivated team
Start-up spirit while being a part of the large international organization with strong values

Fulltime

Nordic Regulatory Affairs Manager

Location

Sweden , Stockholm

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

University degree in Life Sciences or a related field
5+ years of Regulatory Affairs experience within Pharmaceuticals
exposure to other product categories is a plus
Strong knowledge of Nordic regulatory frameworks (experience with Norwegian regulations is an advantage)
Experience with artwork, labeling, and regulatory systems (e.g., Veeva RIM)
Proven ability to work cross-functionally in fast-paced, international environments and interact with regulatory authorities
Fluent in Swedish and English
Strong communication skills with a proactive, solutions-oriented and commercially minded approach
Structured, independent, and collaborative, with the ability to prioritize and drive work in a dynamic setting

Job Responsibility

Drive end-to-end regulatory activities across product classifications, ensuring timely submissions and approvals
Manage lifecycle activities for pharmaceutical products
Lead communication with regulatory authorities and relevant bodies
Review artworks and commercial materials to ensure compliance
Provide strategic regulatory input to enable product launches and market access
Support local implementation of global NPD, EPD, and GeoX projects
Perform pragmatic risk assessments balancing compliance with business needs
Ensure accurate and compliant data in Veeva RIM and artwork systems
Secure compliant product information, translations, and labeling
Maintain national databases and product information platforms

What we offer

Opportunity to create, grow, and encourage
Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
Very positive work environment in a dynamic, international, and motivated team
Start-up spirit while being a part of the large international organization with strong values

Fulltime

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 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

Veeva RIM Project Manager

Proclinical

Location:
United Kingdom , Surrey Heath

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 04, 2026

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Veeva RIM Project Manager

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Location:United Kingdom , Surrey Heath

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