Manager, Submission Management

Purpose: JOB SUMMARY: The Manager of Submission Management will be responsible for the building and maintaining of the Submission Management organization based in RTP, NC. They will be accountable for build, delivery, and archival of paper and electronic submissions for all programs in the US. They will develop and maintain relationships with key individuals in the three R&D sites to ensure on time delivery of submissions of the highest quality. The successful candidate will provide outstanding leadership skills based on a sound knowledge of regulatory and submission standards globally.

ESSENTIAL DUTIES AND RESPONSIBILITIES
-Provides project leadership and expertise in the development of worldwide submissions for the optimal assembly, archival and presentation of submissions to regional regulatory authorities.
-Partnering with product teams will be responsible for project management of activities supporting submission build and delivery.
-Manage global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
-Manage, coordinate, build and dispatch submissions to the Regulatory Agency in compliance with the appropriate regulations and guidance?s.
-Responsible for managing the text, data and image components for worldwide dossiers through cross functional/site liaison.
-Organize, recruit and lead team to develop global standards for eCTD/CTD Submissions to eliminate redundancies and duplication of effort.
-Assist with the definition, development, and implementation of global submissions policies and technologies to meet evolving business needs.
-Provide operational oversight for all US submission activities.
-Provide oversight of activities of Submission Management personnel.
-Assist with training of personnel in the R&D organization in the US.

QUALIFICATIONS:
-5-10 years experience within the pharmaceutical industry, including significant time in Regulatory Operations
-At least 5 years of document management experience
-Substantial experience in filings of INDs, NDAs, ANDAs, BLAs preferably in CTD format or eCTD format
-Knowledge of IND, NDA, MAA, CTD requirements and guidelines
-Outstanding negotiation skills
-Demonstrated ability to work within a cross functional team and a matrix environment.
-Ability to travel as neededClassification:Direct PlacementCompensation:
BOE YearJoin Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
IND, NDA, REGULATORY AFFAIRS, Regulatory GMP/ GLP, CLINICAL SUBMISSIONS, GCP/ ICHContact Information
Contact:Griffin,Matthew E