The (Senior) Director of regulatory affairs will develop and execute strategies for submissions across multiple projects, in line with corporate priorities and in support of Executive Leadership and Board of Directors meetings. The position provides guidance to the cross functional teams for content requirements and compliance with regulations across CMC, nonclinical, and clinical areas. The position supports the regulatory team and actively contributes to all IND, CTA, and future NDA submission activities, including submission management, key messaging, and appropriate timing for key regulatory components of development. Develops the Regulatory Strategy Development Plan in support of program goals. The position participates in developing and maintaining Regulatory procedures.
The (Senior) Director will bring expertise on approval strategies of other products related to the disease areas under study and share up-to date knowledge of competitor’s products and their approval pathways with the project teams and Company management. The position will also ensure up to date knowledge of FDA regulations, guidelines, and current policy are shared and clearly communicated, from general compliance regulations through product specific guidance and clinical data requirements for specific approvals.
Key responsibilities
- Lead, coordinate, write, critically review, and provide input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, Investigator’s Brochure, IMPD, DSUR, clinical study reports).
- Facilitate activities to ensure prioritized objectives are successfully delivered, including team preparation for meetings with FDA, EMA, and other regulatory authorities.
- Facilitate Regulatory Authority communications/interactions.
- Interface with global regulatory authorities and consultants as needed.
- Develop and maintain submission content plans, track documents from authoring to approval.
- Provide operational oversight for all phases of applications to regulatory authorities.
- Manage pre- and post-submission activities, IND, CTA submissions, briefing packages, amendments, and future NDAs/BLAs.
- Stay up to date on new regulations and new guidance (US and ex-US). Proactively research FDA and other HA policies, regulations, and guidance.
- Build in-depth insight in regulatory approval policies and trends, especially new initiatives from FDA’s Oncology Center of Excellence.
- Develop written competitive analyses and share/present to the company teams/management.
- Attend advisory committees, workshops, conferences; gather relevant information for the development projects of the company.
- Share detailed knowledge of other approved products, pivotal studies, label claims.
- Implement project management control and tracking.
- In collaboration with team, perform/manage critical analyses of GXP related data.
Requirements
- Advanced degree in life sciences.
- 8 years of industry experience.
- Must have oncology/immuno-oncology experience.
- Preferably knowledge across requirements for clinical, clinical pharmacology, nonclinical, and CMC.
- Ethical mindset, team player.
- Ability to self-organize; plan and execute a high workload.
- Able to prepare professional high-quality presentations.
- Outstanding communicator (writing and speaking).
- Strong problem solving and analytical skills.
- Extensive knowledge of global submission standards (FDA, EMA, etc.).
- Experience in the development of regulatory strategy, in various phases of the drug development cycle.
- Ability to organize and oversee regulatory submissions.
Note to Employment Agencies: Please do not forward any agency resumes. Nurix will not be responsible for fees related to unsolicited resumes.