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Description

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: oSupervision required. Receives project assignments from manager but has responsibility for managing own projects with oversight. Reviews project progress with manager on a regular basis with direction provided by manager. May assist with onboarding staff.

Skills

Regulatory affairs, Regulatory compliance, pharmaceutical, documentum, ISIpublisher, ISI Toolbox, Docubridge, adobe acrobat, eCTDXPress, Regulatory, Regulatory documents

Top Skills Details

Regulatory affairs,Regulatory compliance,pharmaceutical,documentum,ISIpublisher,ISI Toolbox,Docubridge,adobe acrobat,eCTDXPress

Additional Skills & 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

Experience Level

Entry Level

Job Type & Location

This is a Contract position based out of Florham Park, NJ.

Pay and Benefits

The pay range for this position is $30.00 - $37.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Florham Park,NJ.

Application Deadline

This position is anticipated to close on Jan 7, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.