Veeva Vault Consultant Job at Amaris Consulting (Brussels)

Configuration Specialist

As our next Configuration Specialist, you will contribute to solving meaningful ...

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

At least 3 years of experience as a consultant in a configuration role
Veeva Vault Certified
Deep hands-on understanding of all aspects of the Vault PromoMats configuration
Ability to define standards & best practice and ensure compliance in the configuration & development team
Experience in managing UAT
Experience in delivering end user training
Experience in release management
Robust understanding of IT architecture concepts
Ability to participate in and lead design workshops with the customer

Job Responsibility

Translate customer business requirements into solution architecture, system design, and clear implementation plans by combining strong commercial understanding with excellent technical acumen
Work closely with clients to enhance their digital asset management capabilities through ongoing customer engagement
Configure and administer Veeva Vault PromoMats, including lifecycles and workflows, objects and document management, user permissions and security, and reporting
Understand and advise on integration points for multichannel content, both with Veeva CRM and third‑party technology solutions
Act as a subject matter expert for Veeva Vault PromoMats, guiding customers on digital asset management principles and ensuring optimal use of available Vault functionality
Estimate, design, and engineer robust solution implementation projects in collaboration with a Project Manager
Deliver solutions within a hybrid delivery model, working with internal teams, client teams, and external vendors or service providers
Serve as a reference point for solution design throughout the implementation, proactively monitoring risks and resolving challenges
Contribute to the Content Excellence practice at BASE, combining deep pharma commercial domain knowledge with advanced technology expertise to maximise value from clients’ digital platforms

What we offer

Support for health and wellbeing, covering physical, mental, and social needs
Flexible ways of working, built on trust, autonomy, and balance
Ongoing learning and professional development throughout your career
A modern work setup, with the tools and equipment needed to do great work
Recognition of performance and impact, linked to contribution and results
The opportunity to work on challenges that make a meaningful difference for patients and healthcare systems worldwide

Fulltime

Senior Regulatory Affairs Associate

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

Location

Peru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Minimum 5+ years of professional experience in clinical trial regulatory affairs
Proven experience preparing and submitting clinical trial dossiers to the Ministry of Health (MOH) in Peru, including review of Annex 05 and completion of Annex 33
Demonstrated experience preparing and submitting clinical trial dossiers in other LATAM countries
Proficiency with Veeva Vault or similar document management system
Advanced written and spoken English proficiency
Strong regulatory strategy expertise in Peru and LATAM countries
Excellent verbal communication skills for presenting complex regulatory strategies to international clients
Client-focused approach with ability to understand and anticipate sponsor needs
Strong critical thinking and problem-solving abilities
Exceptional interpersonal and intercultural communication skills

Job Responsibility

Act as Local Regulatory Contact (LRC) and prepare and submit clinical trials through the REPEC Platform in Peru
Allocate 50% of daily time as Global Regulatory Lead for assigned global projects, providing strategic oversight and coordination
Prepare country-specific labels and review LATAM labels for regulatory compliance and consistency
Deliver verbal and written regulatory strategy communications to global sponsors, tailoring recommendations to country-specific requirements
Maintain and update the Trial Master File (TMF) in Veeva Vault with study documents and critical milestone dates
Keep project management tools current, including budget tracking and quality issue (QI) tools

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

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 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

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

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

Team Manager

As a Team Manager of Customer Assistants you'll support your leadership team to ...

Location

United Kingdom , Manchester - Trafford

Salary:

32000.00 - 45600.00 GBP / Year

Waitrose & Partners

Expiration Date

Until further notice

Requirements

Experience of leading a large team in a fast-paced, customer focused environment with a proven track record as a specialist in people and driving a culture of empowerment.

Job Responsibility

Striving for high levels of customer and Partner (employee) satisfaction
Empowering your team to act with authority and accountability in a culture where they feel supported to grow professionally and feel cared for
Building genuine relationships with customers and internal and external stakeholders
Working with the wider shop leadership team, taking on duty manager responsibilities when required
Through the development of a clear resourcing strategy, you will ensure the recruitment of Partners that have the capability, aspiration and passion to deliver outstanding service.

What we offer

Leisure Learning (up to £200 towards certain tutored courses)
25% off at John Lewis and 20% at Waitrose
Clubs and Societies
Holiday & Leave
Pension & Life Assurance
Exclusive Partnership hotels in locations across the UK

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Veeva Vault Consultant

Job Description

Job Responsibility

Requirements

What we offer

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