Lead the preparation, review, and approval of technical regulatory documentation supporting product renewals, variations, new registrations, and rollouts across Latin America.
Responsibilities
Plan, author, coordinate, and review submission-ready CMC technical documentation for medicinal products and food supplements, including CTD Modules 2.3 and 3 and Food Supplement Master Dossiers.
Ensure technical documents are accurate, complete, consistent, scientifically sound, and compliant with applicable CTD standards and regulatory requirements.
Maintain alignment between submission documentation, manufacturers' information, and supporting technical/raw data.
Upload and maintain regulatory documentation in Veeva RIM or applicable document management systems and coordinate stakeholder review and approval.
Serve as the primary point of contact for questions and feedback related to assigned technical documents, including content and formatting.
Requirements
University degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or another relevant scientific field
Nice to have: Latin American regulatory requirements knowledge
Lead the preparation, review, and approval of technical regulatory documentation supporting product renewals, variations, new registrations, and rollouts across Latin America.
Locations (2)
Huixquilucan, México, Mexico
Mexico City, Mexico City, Mexico
Compensation
We will give you a competitive salary and benefits' package.
Responsibilities
Plan, author, coordinate, and review submission-ready CMC technical documentation for medicinal products and food supplements
Ensure technical documents are accurate, complete, consistent, scientifically sound, and compliant with applicable CTD standards and regulatory requirements
Maintain alignment between submission documentation, manufacturers' information, and supporting technical/raw data
Upload and maintain regulatory documentation in Veeva RIM or applicable document management systems and coordinate stakeholder review and approval
Serve as the primary point of contact for questions and feedback related to assigned technical documents
Manage and independently execute regulatory submission planning, publishing, quality control, delivery, archiving and lifecycle management for clinical and commercial programs.
Compensation
Range for this position: $165,000 - $208,500
Responsibilities
Independently format, publish, transmit and archive Health Authority submission types, ensuring submissions are high quality, compliant and delivered according to established timelines.
Serve as subject matter expert for regulatory publishing and document management technologies such as LORENZ docubridge, Veeva Vault RIM, Microsoft Word, Adobe Acrobat and regulatory validation tools, as applicable.
Provide Regulatory Operations expertise and guidance on eCTD structure, content readiness, publishing requirements, validation, dispatch and lifecycle management in accordance with Health Authority requirements.
Perform document- and submission-level technical quality control to ensure completeness, consistency, accuracy and compliance with company standards and regulatory requirements.
Identify IT solutions to enhance Regulatory Operations capabilities in document formatting and submission publishing, automation opportunities and technology enhancements that improve submission quality, efficiency, compliance and scalability.
Requirements
Bachelor’s degree in related discipline and a minimum of nine years of related experience
Supports the regulatory team with planning, preparation, and communication of regulatory activities both within the department and within cross-function teams.
Compensation
Salary range: $85,000-$155,000, title and salary commensurate with experience.
Responsibilities
Supports the regulatory team with writing, editing, reviewing, and compiling documents needed for global regulatory submissions.
Manages regulatory document management systems and maintains regulatory files.
Provides critical review of documentation supporting regulatory submissions, communications and clinical trial conduct.
Develops and maintains project management tools to support the regulatory team and cross functional planning.
Develops and maintains current regulatory knowledge.
Requirements
BS/BA degree in a scientific/health sciences discipline
Own and deliver IND and global regulatory submissions end-to-end, ensuring compliant, high-quality dossiers reach health authorities on time—while driving consistency, efficiency, and operational excellence across submission activities.
Compensation
Warsaw - PL: zł144,100 - zł174,616
Responsibilities
Own and deliver IND and global regulatory submissions end-to-end
Ensure compliant, high-quality dossiers reach health authorities on time
Drive consistency, efficiency, and operational excellence across submission activities
Requirements
Bachelor’s degree (science or related field preferred)
Own and deliver IND and global regulatory submissions end-to-end, ensuring compliant, high-quality dossiers reach health authorities on time—while driving consistency, efficiency, and operational excellence across submission activities.
Compensation
Warsaw - PL: zł144,100 - zł174,616
Responsibilities
Leading coordination of submission activities across global teams
Partnering with stakeholders to define submission strategy and timelines
Managing IND and marketing application submissions from planning through to delivery
Tracking progress, identifying risks, and ensuring milestones stay on track
Executing eCTD publishing and managing submissions via HA portals
Requirements
Bachelor’s degree (science or related field preferred)
The Senior Expert, Regulatory Affairs Operations plays a key role in maintaining reliable regulatory systems and enabling efficient, compliant global submissions at Bavarian Nordic.
Compensation
Salary Range: $120k – 160k
Responsibilities
Responsible and/or back-up for maintaining the integrity of the RIM system as a Business Administrator
Coordinate, validate and support major changes to RA systems or the implementation of new systems and tools
Design, optimize, maintain and support RIM workflows and RIM related business processes in RA
Creating Reporting and Dashboards in Veeva RIM
Responsible for onboarding and (re)training of new and existing employees to the Veeva RIM system and provision of daily support for Veeva RIM to the RA department and other cross functional departments
Requirements
B.Sc. in a Scientific discipline (M.Sc. is a plus)
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