Posted in Compliance 16 days ago.
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Type: Full Time
Location: Saint Louis, Missouri
SUMMARY OF POSITION:
The Regulatory Publishing Associate will be part of the Regulatory Operations team within the Regulatory Affairs function for Specialty Generics of Mallinckrodt Pharmaceuticals and will coordinate the publishing process to ensure timely and accurate submissions to the FDA and other agencies. This position will assemble and publish US FDA eCTD submissions and be expected to assist with other submission types for global applications.
* Contribute to publishing efforts for submissions to FDA and other global health authorities
* Generates drafts and assembles submissions through the use of established templates and ensure eCTD compliance per FDA guidelines
* Reviews format of published output and manages documents within Documentum
* Generates XML Backbone for electronic submissions
* Maintains up-to-date records of completed submissions and submissions in progress and ensures applications are current in Regulatory Viewing software
* Assesses impact of regulation changes to current work procedures and SOPs
* Anticipates Regulatory consequences to changes in application format, and ensures all documentation both received and generated is accurate
* Assists the Regulatory Affairs department members with interpreting FDA and ICH guidance as it relates to the established CTD/eCTD templates, in addition to numerous other submission types (e.g. NDA, ANDA, IND, DMF, PSUR, Annual Reports, Pre-Meeting Packages)
* Enforces use of appropriate request process and responds to user requests in a timely manner
* Maintains knowledge of current regional regulations in regard to application format
* Attends department meetings and interacts closely with department members
* Other duties as assigned with or without accommodation.
Bachelor s degree in scientific discipline
* One to three years of related experience.
* A minimum of one years of experience in eCTD Publishing & Electronic Processing is required.
* Experience with electronic submission software (InSight Publisher) and/or Documentum.
* Knowledge of ICH and FDA guidance.
* Ability to set and manage multiple priorities and projects to complete tasks within established timelines.
* Excellent interpersonal, oral, and written communication skills.
* Able to work with multiple groups of people at one time.
* Proficient with computers and Microsoft Office.
* Strong interpersonal skills, including ability to remain calm, professional, diplomatic, and positive.
* Flexibility to accept new duties and responsibilities as assigned
* Ability to work in a fast paced environment
* Ability to allocate down-time effectively
This position reports to the Manager, Regulatory Operations and has no direct reports.
Typical office working conditions.
Mallinckrodt Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.