Regulatory Affairs – Submissions Project Senior Manager/Director

Regulatory Affairs – Submissions Project Senior Manager/Director

Overview

We are currently seeking a full-time, office-based Regulatory Affairs Manager/Director to join LSK Biopharma. This position will work with our clinical and product development teams to contribute to the strategic planning and preparation of regulatory submissions and supports the formatting, organization, and structuring of major regulatory submissions for our lead product. This person will serve as an internal project manager for the submissions process to ensure that submissions are prepared in a compliant, high-quality fashion and within assigned timelines.
This position will be the responsible for ensuring the scheduling, timelines, follow-up and preparation of these submissions meet our corporate goals.  This work will involve managing internal or external content is provided in a timely manner and the management of vendor(s) responsible for finalization and submission.  The incumbent also oversees the document acquisition process and storage/filing of draft and final documents. 

If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.

Responsibilities

  • Function as a Project Manager within LSKB
  • Oversee the document acquisition process and storage/filing of draft and final documents to confirm quality and timelines are met. 
  • Project manage the preparation of regulatory documents for submission to the FDA, EMA, PMDA, KFDA and other regulatory authorities.
  • Facilitate quality and timely delivery from internal and outsourced related activity to ensure appropriate writing, publishing, and correct placement in eCTD hierarchy;
  • Identifies/anticipates roadblocks and helps identify solutions to support the scheduling and timelines of submissions.
  • Acts as contact for collection of required documents, and distribution of those documents for review and approval by LSKB management and subsequent provisioning to submission vendor.
  • Ensures the accuracy and completeness of electronic and hard copy regulatory files.
  • Manage NDA/MAA project deliverables and timelines;
  • Identifies/anticipates roadblocks and helps identify solutions to support the scheduling and timelines of major regulatory submissions. 
  • Conduct meetings with internal teams and vendors as needed, including meeting agendas, minutes, action items;
  • Ensure maintenance of regulatory records, including archive of submissions and FDA correspondences files;
  • Ensure submissions comply with applicable regulations and guidance documents;
  • Track submissions and ensure timely filing of documents.

Qualifications

Minimum BA/BS or equivalent work experience in life science or closely related
Minimum of eight (8) years overall experience in the pharmaceutical industry.
Minimum of five (5) years direct experience with regulatory submissions including either NDA or MAA or global equivalents.
Proven project management skills; ability to multi-task, meet deadlines as well as coach colleagues to meet deadlines
Working knowledge of computer software, including advanced MS Word features.
Experience with publishing tools and electronic document management systems as used within the pharmaceutical industry.
Strong problem-solving skills. Ability to manage tasks with clear objectives/goals, measures, process, progress, and results with attention to detail.
Strong interpersonal, communication and influencing skills and ability to collaborate effectively with other groups in a matrix organization.

Email cover letter and resume to angieprice@lskbiopharma.com