Regulatory Submission Associate III - Remote (Part-Time)

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

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For further inquiries regarding the following opportunity, please contact one of our Talent Specialists :

Hema Malini at

(630) 847 0275

Meghna at

(224) 369 4230

Title : Regulatory Submission Associate III - Remote (Part-Time)

Location : Remote

Duration : 11 Months

Estimated Hours per Week : 30 hrs

Position Overview

The

Senior Submissions Associate

will play a key role in preparing electronic regulatory submissions by overseeing document formatting, remediation, quality control, and publishing processes. This position is also responsible for ensuring that eCTD submissions are compliant, as well as for maintaining accurate, consistent, and timely planning and tracking of submissions. This individual will collaborate with cross-functional teams as needed to coordinate workflow and manage submission timelines effectively.

This role is fully remote and will report directly to the Head of Regulatory Operations.

Responsibilities

Coordinate the compilation, publishing and submission for client applications in accordance with established timelines and submission dates in a compliant manner using applicable software (i.e. DocuBridge, Veeva, etc.) ensuring consistency, completeness, and adherence to regulatory Health Authority standards.

Responsible for the formatting and document remediation of regulatory health authority documents submitted.

For assigned submissions, collaborate with regulatory leaders to establish the submission scope, goals, tracking / status, and deliverables. Subsequently, plan and schedule submission timelines and milestones accordingly.

Critically review regulatory submissions to ensure clarity, consistency, and conformance to regulations, guidelines and regulatory strategy as well as suitability for submission to regulatory agencies.

Responsible for troubleshooting and resolving publishing technical issues.

Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation and submissions.

Manage the archiving of regulatory submissions and correspondences in the Regulatory Information Management (RIM) system.

Attend project team meetings as needed to assist in the compilation of submissions.

Ensure adherence to Company Standard Operating Procedures.

Prepare and submit reports to senior management, as required

Research and contribute to developing regulatory filing procedures (CMC, clinical and non-clinical) to ensure the shortest review and approval times for regulatory applications

Assist in the creation of guidelines and techniques that support improving the efficiency of for submissions as well as providing training on these areas as required

Required Experience

A minimum of a bachelor's degree in a scientific or technical discipline is desired; equivalent work experience may be accepted.

A minimum of 5 years of experience in regulatory operations within the pharmaceutical industry with dedicated expertise in compilation, formatting, publishing, and placement of data and documents in eCTD format.

Possess extensive experience compiling and publishing eCTD and non-eCTD investigational submissions such as but not limited to US INDs, US IND amendments, Canadian CTA's, IMPDs and other international submissions.

Experience working with external publishing vendors desired.

Expertise in Regulatory software ie, Lornez, DocuBridge and Veeva RIM

Expertise in understanding CTD / eCTD submission structure and requirements for global submission types (e.g., IND, NDA, MAA, NDS, CTA, DSUR, PSUR, REMS, etc.).

Excellent verbal and written communication and presentation skills. A strong training skill is a plus.

Very strong interpersonal skills and ability to build relationships with cross-functional teams.

Superior knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (PDF Tools, Toolbox, etc), eCTD publishing tools, eCTD validation and viewing tools.

Solid experience and knowledge of SharePoint technology and project management tools are desired. Experience with document management systems such as Veeva Submisison / Submission Archive desirable

Strong knowledge of StartingPoint (or similar eCTD authoring) templates.

Demonstrated project management, organizational, and planning skills.

Ability to excel at multi-tasking, maintain strong attention to detail, and remain result driven to consistently meet deadlines.

Ability to work independently with minimal supervision, as well as work in a team environment with changing timelines and priorities.

Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines.

Strong understanding of the internal and external interdependencies among submission activities that impact the schedule or quality of a submission to proactively manage these interdependencies, ensuring that submission goals are met in a timely manner and uphold the highest standards of quality.

About us :

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.