Regulatory Affairs – Senior Manager
Job Title
Regulatory Affairs – Senior Manager
Job Status
Full Time
Job Summary
We are currently seeking a full-time, office-based Regulatory Affairs Senior Manager to join LSK BioPharma. This position will work with our clinical and product development teams to contribute to the preparation of regulatory submissions for our lead product, rivoceranib. This position will be the responsible for ensuring the scheduling, timelines, follow-up, preparation and review 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.
Responsibilities
- Provide regulatory support for the global project team on the designated product(s).
- Has primary responsibility for coordinating the preparation of drafts, edits, review and submission of regulatory dossiers and responses to information requests in support of investigational new drug applications, and post-approval submissions, for US and ROW (e.g., IND, NDA, CTD, CTA, IMPD, MAA, Annual Reports, Amendments, Supplements etc.).
- Prepare regulatory documents for submission to the FDA, EMA, PMDA, MFDS and other regulatory authorities.
- Assist with NDA/MAA project deliverables and timelines and facilitate quality and timely delivery from internal and outsourced related activity to ensure appropriate writing, publishing, and correct placement in eCTD hierarchy.
- Assist and coordinate regulatory meetings for assigned projects.
- May be responsible for primary or back-up FDA contact for assigned project.
- Prepare and submit the required submissions to FDA in support of clinical trials and marketing applications. Review and approve documents used in regulatory submissions (including protocols and reports).
- Ensure the project team objectives and timelines are supported by regulatory deliverables.
- Keep abreast of all pertinent laws, regulations and guidance relevant to oncology and the specific product areas.
- Provide interpretation of regulations and guidance relating to product development.
- Coordinate with consultants, vendors and contractors as required including meeting agendas, minutes, action items.
- Assist with compliance activities, internal audits and inspections.
- 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 six (6) years overall experience in regulatory affairs.
- Minimum of two (2) years direct experience with regulatory submissions including either NDA or MAA or global equivalents.
- Ability to multi-task, meet deadlines as well as coach colleagues to meet deadlines
- Working knowledge of computer software, including advanced MS Word features.
- Strong problem-solving skills. Ability to manage tasks with clear objectives/goals, measures, process, progress, and results with attention to detail.
- Strong interpersonal, communication skills and ability to collaborate effectively with other groups in a matrix organization.
Send resume and cover letter to angieprice@elevartherapeutics.com.
