Regulatory Affairs Specialist

POSTED: August 17, 2021
BUSINESS: Novosteo, Inc.
POSITION TYPE: Full-time
START DATE: Immediate Availability

Location: Purdue Research Park in West Lafayette, Indiana
Compensation: Competitive based on experience
Benefits: Health insurance, vision insurance, 401K, 401K match, paid time off and parental leave.

Job Summary: Novosteo was founded to reduce the morbidity, mortality and loss of productivity associated with bone fractures. Based on discoveries of agents that accelerate bone regeneration and breakthroughs in methods to target these agents selectively to fracture surfaces, Novosteo has designed a series of fracture-targeted drugs that concentrate a drug's healing power specifically at the fracture site, thereby greatly accelerating and improving the healing process. The mission of Novosteo is to reduce the debilitating and often life-threatening effects of bone fractures. This Job provides the exciting opportunity to be part of an innovative team contributing to the development and discovery of new pharmacological solutions for life threatening orthopedic diseases.

Job Summary: The Regulatory Affairs Specialist supports the regulatory submission process by tracking, formatting and publishing submission documents for paper and electronic format in compliance to internal and external specifications, formatting MS Word documents, Coordinating regulatory archive and providing system support for SharePoint platform.

Responsibilities:

  • Publishing & Document Processing
  • Format MS Word and Adobe Acrobat files to a state of submission-readiness
    • Tracks and compiles submission component documents from paper and/or electronic sources; edits, formats, assembles, and publishes submission documents in accordance with established timelines.
  • Ensures completion of high-quality submissions in electronic
  • (eCTD) and paper format for compliance with all applicable regulations, guidance’s, and Regulatory Operations document specifications.
  • Assists submission authors and regulatory liaisons in the planning and preparation of regulatory submissions; when appropriate, composes regulatory forms, correspondence, and text.
  • Assists in the development of and implements documentation standards, templates, and procedures related to the formatting, publishing, and archiving of both electronic (eCTD) and paper submissions.
  • Archiving and Regulatory Information Management
  • Manage and maintain correspondence and other records in Sharepoint
  • Archives/retrieves archived regulatory documents (both paper and electronic) as necessary.
  • Ensure that all documents are maintained in Sharepoint and are organized and identified so that they can be easily retrieved.
  • Ensure that records are maintained in accordance with current procedures and the Records Retention Schedules.
  • Ensures that all submission planning and tracking is done per procedures

Qualifications:

  • 5+ years of relevant experience and a BA or BS or 2+years with Master or above Successful candidates will have significant experience within a Regulatory
  • Publishing environment including hands on eCTD experience and broad industry standard systems knowledge.
  • Working knowledge of business software, including: MS Word, Excel, PowerPoint, Teams, OneDrive, Project, Adobe Acrobat and Outlook.
  • Experience in the preparation and submission of documents using regulatory/document management systems
  • Strategic thinking is required, with a focus on process improvement and optimization.
  • Excellent verbal and written skills and attention to detail are required as well as time management and prioritization skills.
  • Candidates will demonstrate an ability to balance multiple tasks to achieve goals and to meet deadlines and customers’ expectations.
  • Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Affairs.
  • Ability to communicate technical issues to a non-technical audience.
  • Must have excellent verbal, written, extensive organizational and time management skills and a strong attention to detail.
  • Experience working in and directing cross-functional teams is highly preferred
  • Familiarity with pharmaceutical development and global Regulatory submissions is required.

Additional Information

  • Novosteo will not sponsor work authorization for this position.
  • A background check is required for employment in this position.
  • FLSA: Exempt (Not eligible Overtime)
  • Novosteo Inc is an EEO/AA employer. All individuals, including minorities, women, individuals with disabilities and veterans are encouraged to apply.

Industry

  • Pharmaceutical
  • Biotech
  • Hospital & Health Care 

 

Send applications to:
Jnielsen@novosteo.com



  • Job Listings

Kurz Purdue Technology Center, 1281 Win Hentschel Blvd., West Lafayette, IN 47906, 765-588-3470

© 2020 Purdue Research Foundation | Maintained by Purdue Research Foundation

Trouble with this page? Please contact Purdue Research Foundation by Phone, 765-588-3470, or FAX, 765-463-3501.