Job description
Job Title: Regulatory Submission Associate III – Remote
Duration: 12 months with possible extension
Pay rate: $61/hr. on W2
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.
Job 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 for submissions as well as providing training on these areas as required.
Minimum Requirement:
- 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:
Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. We continue leading global talent solutions with a dynamic presence in over 160 countries, including the USA, China, Canada, Singapore, Japan, Philippines, UK, India, Netherlands, and the EU.
IntelliPro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity at https://intelliprogroup.com/.
Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, IntelliPro provides a comprehensive benefits package, all subject to eligibility.
