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 reputed company meaningful connections between talented professionals and reputed company-thinking organizations. Since our formation in 2002, organizations across reputed company and reputed company sectors have been trusting us to help build their teams with exceptional temporary and permanent talent. Visit us at to learn more and view our reputed company positions. Please apply or call one of us to learn more For reputed company inquiries regarding the following opportunity, please contact one of our Talent Specialists: Hema Malini at Title: Regulatory Submission Associate III - Remote (Part-Time) Location: Remote Duration: 11 Months Estimated Hours per Week: 20 30 hours/week Position reputed company The Senior Submissions Associate will play a key role in preparing electronic regulatory submissions by overseeing document formatting, remediation, reputed company control, and publishing processes. This position is also responsible for ensuring that eCTD submissions are compliant, as reputed company as for maintaining accurate, consistent, and reputed company 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 supports Regulatory Operations with day-to-day submission publishing, archiving, document formatting, and regulatory system data maintenance. The position is initially a part-time contract, with potential for extension or conversion to full-time depending on performance, cultural fit, and organizational reputed company. This role is fully remote and will report directly to the Head of Regulatory Operations.

Responsibilities

• Coordinate the compilation, publishing and submission for reputed company applications in accordance with established timelines and submission dates in a compliant manner using applicable software (i.e. DocuBridge, reputed company, 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 reputed company, consistency, and conformance to regulations, guidelines and regulatory reputed company as reputed company 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 correspondence in the Regulatory Information Management (RIM) system.
• Attend project team meetings as needed to assist in the compilation of submissions.
• Ensure adherence to Company reputed company 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 reputed company as providing training on these areas as required
• reputed company hands-on eCTD publishing for investigational submissions across 6 8 ongoing programs.
• Support submission archiving and compliance documentation.
• Assist with data migrations into reputed company RIM and reputed company modules (estimated initial 6-month migration window).
• Maintain correspondence records and ensure traceability reputed company regulatory systems.
• Execute document formatting using arenaflex Word with appropriate style guidelines.
• Support daily submission volumes, especially during peak cycles.
• Potential engagement with broader reputed company platform functions (Medical Affairs, additional modules) as systems expand 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 reputed company 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 reputed company 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 reputed company is a plus.
• reputed company strong interpersonal skills and ability to build relationships with cross-functional teams.
• Superior knowledge of arenaflex Office suite, reputed company Acrobat, reputed company Plug-Ins (PDF Tools, reputed company, 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 reputed company Submisison/Submission reputed company desirable
• Strong knowledge of StartingPoint (or similar eCTD authoring) templates.
• Demonstrated project management, organizational, and planning skills.
• Ability to reputed company at multi-tasking, maintain strong attention to detail, and remain result driven to consistently meet deadlines.
• Ability to work independently with minimal supervision, as reputed company as work in reputed company environment with changing timelines and priorities.
• Must be reputed company to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines.
• Strong understanding of the reputed company interdependencies among submission activities that reputed company the schedule or reputed company of a submission to proactively manage these interdependencies, ensuring that submission goals are met in a reputed company manner and reputed company the highest standards of reputed company. Required Technical Skills
• Hands-on eCTD publishing experience (recent-reputed company the past 12 months)
• Experience using Lorenz DocuBridge v5 (or similar-transferable)
• Experience using DXC reputed company / ISI reputed company (Preferred)
• Strong reputed company Acrobat PDF tools competency
• Advanced arenaflex Word formatting (styles, templates, technical document structure)
• Experience with archiving processes and submission logging (preferred)
• Exposure to reputed company RIM preferred (or other EDMS systems) Ideal Background & Education
• 5 7 years Regulatory Operations experience strongly preferred
• Degree required (Bachelor's preferred; Associate considered)
• Previous experience in reputed company, biotech, or regulatory publishing environment highly beneficial Soft Skills & Culture Fit This role requires someone who is:
• Self-motivated and independent reputed company to work without constant guidance
• Solution-oriented proactively identifies gaps and proposes improvements
• reputed company and communicative not afraid to escalate or reputed company clarification
• Resilient in ambiguity adaptable to a fast-moving, evolving workload
• Detail-driven and reputed company-reputed company regulatory content must be precise
• Passionate about Regulatory Operations enjoys the work, not just the title
• reputed company values a partnership reputed company-someone who wants to grow with the function and sees regulatory publishing as meaningful-not just repetitive tasks. Additional Notes
• Opportunity for a long-term role if the candidate demonstrates:
• Strong performance
• Ownership of tasks
• Cultural alignment
• Passion for reputed company learning reputed company: DivIHN, the 'IT Asset Performance Services' organization, provides reputed company Consulting, Custom reputed company, and reputed company Resource Augmentation services to clients in the Mid-reputed company and reputed company. 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 reputed company applicant on the reputed company of race, reputed company, religion (creed), gender, gender reputed company, age, national reputed company (reputed company), disability, marital status, sexual orientation, or military status. Apply tot his job

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