The Submission Manager will be an integral member of the Global Regulatory Dossier Management Group. On a daily basis, the Submission Manager will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines and projects, and utilizing a wide array of document management, authoring, and publishing tools. The Submission Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability.
Working closely with the Regulatory Leads, the Submission Manager will have an opportunity to develop a broad base of skills in both Regulatory Affairs and submission management.
Plan and manage Regulatory submissions, working with Regulatory Leads to develop and submit filings according to agreed upon processes and timelines.
Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management.
Identify issues that may delay product or project and recommend appropriate action.
Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology.
Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity.
Prepare and maintain templates that meet Regulatory electronic submission standards.
Assist in development and maintenance of our electronic submission capability at Millennium, representing the Regulatory business function on technology teams.
Basic qualifications: Minimum of 4 years of experience within the pharmaceutical industry and strong submission management and/or project management experience is required. Skill in using desktop applications and proficiency in computer systems and procedures is required.
Preferred qualifications: Experience in preparing regulatory submissions (e.g., investigator documentation, protocol amendments, etc.) is highly desired. Experience in a Regulatory Submissions organization along with a working knowledge of drug development process is strongly desired.
If you are interested in the company name and exact location
for this opportunity, please enter your email address below.
Get In Touch With Us
Client Testimonials
"My confidential career search was handled with respect and they listened to what I wanted. I moved from New Jersey to Colorado with help from InVision Inc."
"I have never seen this quality of talent assembled for a Regulatory Vice President opening. Regulatory staffing is very unique. InVision produced great results in a short amount of time."
"I called InVision on a Tuesday morning with a very unique regulatory opening and they presented (4) qualified candidates in 3 days... We hired the second person they submitted. Results! Thank You"
"The staff at InVision prepared me for a great interview and guided me along the interview process step by step. Unique niche recruiters have come and gone InVision has been around for years and having RA/QA knowledge really helps."
"Your friend Paula should contact the world's greatest RA and QA recruiting company, InVision I can serve as a reference if needed."
"I sent InVision my regulatory resume looking to relocate to California and they presented (2) director level openings right away and they followed up with me. Feedback from my resume really helped."
