SUMMARY OF POSITION:

The Senior Regulatory Publishing Specialist 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 other submission types for global applications.

ESSENTIAL FUNCTIONS:

• Coordinates 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 Veeva and Insight suite.
• 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.
• Assesses impact of software updates to the current work procedures.
• 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.
• Participates and represents the Regulatory Operations group on projects relating to updates to software and submission formats.
• Mentor and train new hires and more junior members of the Regulatory Operations group.
• Other duties as assigned with or without accommodation.

MINIMUM REQUIREMENTS:

Education:                              

Bachelor’s degree in scientific discipline

Experience:

Five to seven years of related experience.

A minimum of four  years of experience in eCTD

Publishing & Electronic Processing is required.

Experience with electronic submission software

(InSight Publisher) and/or Veeva.

Knowledge of ICH and FDA guidance required.

Knowledge of Health Canada and EU regulations preferred.

Skills/Competencies:

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.

Other Skills:

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.

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

This position reports to the Senior Director, Regulatory Affairs and has no direct reports.

WORKING CONDITIONS:

Typical office working conditions.

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.