Business Analyst- RIM
3B Staffing LLC, Boston, MA, United States
Business Analyst- RIM- Remote
Position Overview:
We are seeking a Regulatory Business Analyst to play a pivotal role in the design and implementation of our future-state Regulatory Information Management (RIM) infrastructure. This role requires a unique blend of regulatory operations expertise and RIM system implementation experience, with a strong preference for hands-on work in Veeva Vault RIM and other RIM technologies.
The ideal candidate will collaborate closely with Regulatory Operations to define, document, and optimize business processes, ensuring alignment between organizational needs and the capabilities of the RIM platform. This individual will act as a hybrid Business Analyst and Project Manager, guiding the organization through the transition from current to future ways of working, with occasional involvement in adjacent initiatives such as METAFAIR and Medical
Communications.
Key Responsibilities:
Partner with Regulatory Operations to define business processes and workflows aligned to future-state RIM capabilities.
Lead discovery and gap analysis sessions to assess current ways of working and recommend optimized processes for RIM adoption.
Drive the setup and configuration of the RIM infrastructure, ensuring business alignment and operational readiness.
Support change management by guiding regulatory stakeholders through the RIM transformation and enabling system adoption.
Serve as the bridge between regulatory and technical teams, translating business needs into actionable functional and technical requirements.
Assist with training plans, user acceptance testing (UAT), and documentation for RIM implementation.
Ensure RIM capabilities support regulatory compliance, global submission needs, and internal governance standards.
Participate in or support related projects (e.g., METAFAIR, Medical Communications) where regulatory/RIM expertise is applicable.
Required Qualifications:
7+ years of experience in Regulatory Affairs or Regulatory Operations, with 3+ years directly supporting or implementing RIM systems.
Demonstrated expertise in Veeva Vault RIM; experience with other platforms (e.g., ArisGlobal, Ennov, Lorenz) is a strong plus.
Proven ability to define and document business processes and lead transformation initiatives in regulatory domains.
Experience acting in a Business Analyst and/or Project Manager capacity within life sciences or regulatory environments.
Strong understanding of regulatory submissions, dossier management, HA interactions, and compliance expectations.
Excellent stakeholder communication skills, with the ability to guide and educate cross-functional teams.
Preferred Skills:
Experience supporting related domains such as Medical Affairs or Med Communications.
Familiarity with agile delivery or hybrid methodologies.
Ability to work within budget constraints and adapt plans to fit available resources.
Ideal Candidate Profile:
A collaborative, hands-on problem-solver who can bring clarity to complex regulatory workflows.
Comfortable navigating between business and technical conversations.
Capable of building trust with regulatory stakeholders and leading them through system change.
Position Overview:
We are seeking a Regulatory Business Analyst to play a pivotal role in the design and implementation of our future-state Regulatory Information Management (RIM) infrastructure. This role requires a unique blend of regulatory operations expertise and RIM system implementation experience, with a strong preference for hands-on work in Veeva Vault RIM and other RIM technologies.
The ideal candidate will collaborate closely with Regulatory Operations to define, document, and optimize business processes, ensuring alignment between organizational needs and the capabilities of the RIM platform. This individual will act as a hybrid Business Analyst and Project Manager, guiding the organization through the transition from current to future ways of working, with occasional involvement in adjacent initiatives such as METAFAIR and Medical
Communications.
Key Responsibilities:
Partner with Regulatory Operations to define business processes and workflows aligned to future-state RIM capabilities.
Lead discovery and gap analysis sessions to assess current ways of working and recommend optimized processes for RIM adoption.
Drive the setup and configuration of the RIM infrastructure, ensuring business alignment and operational readiness.
Support change management by guiding regulatory stakeholders through the RIM transformation and enabling system adoption.
Serve as the bridge between regulatory and technical teams, translating business needs into actionable functional and technical requirements.
Assist with training plans, user acceptance testing (UAT), and documentation for RIM implementation.
Ensure RIM capabilities support regulatory compliance, global submission needs, and internal governance standards.
Participate in or support related projects (e.g., METAFAIR, Medical Communications) where regulatory/RIM expertise is applicable.
Required Qualifications:
7+ years of experience in Regulatory Affairs or Regulatory Operations, with 3+ years directly supporting or implementing RIM systems.
Demonstrated expertise in Veeva Vault RIM; experience with other platforms (e.g., ArisGlobal, Ennov, Lorenz) is a strong plus.
Proven ability to define and document business processes and lead transformation initiatives in regulatory domains.
Experience acting in a Business Analyst and/or Project Manager capacity within life sciences or regulatory environments.
Strong understanding of regulatory submissions, dossier management, HA interactions, and compliance expectations.
Excellent stakeholder communication skills, with the ability to guide and educate cross-functional teams.
Preferred Skills:
Experience supporting related domains such as Medical Affairs or Med Communications.
Familiarity with agile delivery or hybrid methodologies.
Ability to work within budget constraints and adapt plans to fit available resources.
Ideal Candidate Profile:
A collaborative, hands-on problem-solver who can bring clarity to complex regulatory workflows.
Comfortable navigating between business and technical conversations.
Capable of building trust with regulatory stakeholders and leading them through system change.