Regulatory Publishing Specialist

3 weeks ago

Pittsburgh Pennsylvania, United States Cook Group Full time
Overview:
Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Regulatory Publishing Specialist II at Cook MyoSite, Inc. is responsible in aiding in the compilation, coordination, and submission of documents to the U.S. Food and Drug Administration and other Regulatory agencies, as well as providing Regulatory Operations support. 

Responsibilities:
• Preparation, coordination / compilation of Regulatory submissions, publications, and filings to U.S. FDA and other Regulatory agencies, including but not limited to:
INDs, BLAs, amendments, supplements, DMFs, annual reports, ADEs, Drug Registration Listing, packaging and labeling, and other regulatory filings
• Proficient in eCTD compliance; document optimization; book marking; hypertext linking; publishing;
• Management of eCTD publishing compliance to regulatory standards and requirements
• Creation and maintenance of eCTD templates based on FDA guidance documents and checklists
• Structure of Modules (1-5)
• ePADERS (Periodic Adverse Drug Experience Reports) submissions to FDA via FDA Electronic Submissions Gateway (ESG) portal; familiarity with ICSRs and FAERS portal submissions
Skilled in Adobe Acrobat DC, Lorenz Validation (or other publishing systems),
• Creation and submission of Structured Product Labeling (SPL) for drug listing, drug establishment registration, Self ID, Labeler Codes, and more
• Archival of submissions in electronic and hard copy format; maintains up-to-date records of completed submissions and submissions in progress
• Perform Quality reviews of submissions for publishing
• Participates in the writing and reviewing of Regulatory processes (BOP, Work Instructions and internal guidelines)
• Maintains schedule of and file post-approval documentation
• Project management of submissions
• Interact with regulatory personnel and/or clients to help ensure components are received in a timely manner
• Track progress of all components and relay information to management
• Interact effectively with outside organizations to obtain necessary information
• Develop and adhere to timelines

Qualifications:
• Undergraduate degree in any Life Sciences, or 2-4 years of direct, relevant experience in Regulatory Affairs publishing to provide a comparable background

• Minimum of 2-4 years of experience in Regulatory Affairs or GMP/GCP setting

• Knowledge of regulations and guidelines governing biological product development (particularly clinical)
• Prior experience creating technically compliant regulatory submissions using technology such as MS Word and Adobe Pro

• Advanced proficiency in MS Office, specifically, advanced knowledge of Adobe, OneNote, Excel, Word and PowerPoint
• Demonstrable knowledge of eDMS and regulatory information submission applications

• This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals

 

Physical Requirements:

• Remote position

• Travel: Less than 10%

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.
 

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