Regulatory Affairs Associate I

Job Description

Job Description

• What are the top 3-5 skills, experience or education required for this position :
• eCTD submission publishing (advertising and promotional 2253 submissions if possible)
• US regulatory FDA guidelines / CFR submission / regulatory project management

Veeva Promomats experience

• Lorenz publishing software experience
• The Associate, Regulatory Affairs Submission Management, manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams.
• With input from the submission teams, this individual establishes and maintains submission content planners and associated timelines, facilitates tactical submission team meetings, prepares content planners for publishing, interfaces with publishing vendor, and fulfills Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications.
• This individual is recognized as a very knowledgeable in their discipline expert and in regulatory affairs submission management.

Responsibilities :

• Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submission projects to ensure the timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities and can be easily navigated and reviewed by a regulatory agency.
• Acts as RA Submissions support to project teams providing guidance and communication of established submission processes and standards.

Provides input to project publishing timelines and deliverables.

• Participates in submission team meetings. Expedites, manages, and coordinates multiple concurrent interrelated activities for submission projects in the delivery of low to moderately complex published submissions within the required timelines.
• Anticipates obstacles and proposes solutions within the team.
• Coordinates submission publishing with offsite publishers / provides notification to ensure all required resources are available to meet submission timelines.
• Prepares content planner for publishing and works with vendor to resolve publishing issues.
• May perform in-house publishing tasks
• Facilitates the creation or procurement of submission content deliverables such as cover letters and forms
• Performs detailed quality reviews of published output to ensure compliance with
• Regulatory Standards and Health Authority guidances including verification of content, bookmarks, hypertext links and tables of content in low to moderately complex submissions.
• Facilitates team reviews.
• Contributes to the development of optimal business processes and standards within the department to ensure high levels of customer support and to achieve high quality submissions.
• Contributes to the implementation of internal process and standards documents relating to publishing and publishing deliverables.
• Suggests and contributes to process improvements, including changes to software and business processes.
• May participate on internal project teams to update business software.

Demonstrates ability to influence without direct authority.

• Builds and maintains positive relationships internally and externally.
• Position accountability / scope : o Supervision required o Receives project assignments from manager but has responsibility for managing own projects with oversight o
• Reviews project progress with manager on a regular basis with direction provided by manager
• May assist with onboarding staff.

Qualifications :

• Required Education : Bachelor’s Degree
• Required Experience : Two years pharmaceutical or industry related experience
• Preferred experience : Publishing related software tools e.g. Documentum, eCTDXPress / ISIPublisher, ISI Toolbox / DocuBridge / Insight platform, Adobe Acrobat.
• NOTE : Higher education may compensate for years of experience. Years of experience may also compensate for lower education

Company Description

Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data / AI.

With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.

Company Description

Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data / AI.

With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.