LeadStack
LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.
Job Title Regulatory Submission Associate III
Location Research Triangle Park, NC – 27709 - Remote
Duration 12 months Contract.
PR $50/hr - $60/hr on W2
Estimated Hours per Week 30 hr/week
Job Description 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 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 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 Submission/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.
Should you have any questions, feel free to call me on (415) 322-5419 or send an email on akarash.yathiraj@leadstackinc.com.
Thanks and Regards, Akarsh Yathiraj Senior Recruiter. C. (415) 322-5419 D. (415) 322-5419 A. 611 Gateway Blvd, Ste 120 South San Francisco, CA 94080 W. www.leadstackinc.com
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Job Title Regulatory Submission Associate III
Location Research Triangle Park, NC – 27709 - Remote
Duration 12 months Contract.
PR $50/hr - $60/hr on W2
Estimated Hours per Week 30 hr/week
Job Description 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 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 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 Submission/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.
Should you have any questions, feel free to call me on (415) 322-5419 or send an email on akarash.yathiraj@leadstackinc.com.
Thanks and Regards, Akarsh Yathiraj Senior Recruiter. C. (415) 322-5419 D. (415) 322-5419 A. 611 Gateway Blvd, Ste 120 South San Francisco, CA 94080 W. www.leadstackinc.com
#J-18808-Ljbffr