Job opportunities

Senior Associate, Regulatory Affairs Operations

Location

Illinois

City

Deerfield

Department

701 - Regulatory

Description

Senior Associate, Regulatory Affairs Operations

SUMMARY:

No company knows the brain better. Lundbeck is uncompromisingly committed to the research, development and delivery of targeted therapies for people living with significant psychiatric and neurological disorders. At Lundbeck, we believe life is too beautiful to be interrupted by brain disorders. So, we pursue imaginative solutions, driven by passionate people committed to do the right thing for our patients, our company and our communities. Lundbeck strives to be a leader in depression, schizophrenia, Alzheimer’s disease and Parkinson’s disease.

 

For Lundbeck, making a meaningful difference for patients is more than an aspiration: it is a commitment that shapes everything we do. Our advocacy for patients isn’t an invented “company value” – it is at the core of who we are and motivates every individual at Lundbeck. Our ongoing engagement with patient communities is not what you might expect from a pharmaceutical company – we create our own programs to help patients and caregivers not simply manage their conditions but thrive in spite of them.

The Senior Associate, Regulatory Affairs Operations works independently to support activities related to the review, tracking, compilation, publishing, technical validation, submission and archiving of regulatory submissions to health authorities worldwide.  The Senior Associate will ensure conformance with regulatory requirements, guidelines, internal standards and timelines.

ESSENTIAL FUNCTIONS:

  • Manages and prepares IND, NDA, BLA and DMF lifecycle and original IND regulatory submissions in eCTD format including: technical review of critical components for accuracy; compliance with Health Authority requirements and internal standards.
  • Coordinates the submission of annual reports and ensures timely, compliant submissions.
  • Works directly with submission owners to prioritize submissions and maintain submission schedule.
  • Coordinates and provides oversight to contractor support for regulatory submissions.
  • Utilizes various software tools and plugins to ensure documents and submissions meet all technical requirements for submission.
  • Develops, maintains and assists with training on training and tracking materials documenting regulatory lifecycle submissions and processes.
  • Creates and ensures document/submission index is complete and accurate to ensure a complete, compliant, quality submission and archival in our EDMS.
  • Supports the registration, renewal, transfer of products in International markets for Lundbeck US and Lundbeck HQ as needed.
  • Provides support to Records & Information Management in the maintenance and archiving of regulatory documentation in Central Files.
  • Works in conjunction with team members to develop processes for the creation of electronic submission ready documents.
  • Provides ad-hoc submission support to RA Staff.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university
  • 3+ years experience in Regulatory, Regulatory Operations or R&D Submission Support function within the pharmaceutical industry
  • 2+ years experience working directly with eCTD publishing software
  • Proficiency with MS-Office Suite and Adobe Acrobat
  • Demonstrated experience with Adobe plugins, e.g. ISI Toolbox
  • Experience and demonstrated proficiency with document management systems
  • Demonstrated ability to adjust priorities to successfully complete multiple tasks with similar deadlines
  • Attention to detail and strong organizational skills
  • Ability to work under strict deadlines

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • Bachelor's Degree in a scientific field (such as Biology, Microbiology, Chemistry)
  • Self-starter, able to work independently with minimal supervision
  • Flexibility to adapt quickly to changing requirements from health authority guidelines and shifting submission priorities
  • Excellent written and oral communications skills

TRAVEL

  • Willingness/Ability to travel up to 5% domestically. International travel may be required

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Lundbeck is a global pharmaceutical company highly committed to improving the quality of life of people living with psychiatric and neurological disorders.

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