The Head of Regulatory Affairs at Nurix will have primary responsibility for the oversight and management of Regulatory matters related to Nurix’s commercial and development product pipeline globally in coordination with key internal stakeholders. In conjunction with that, the Director of Regulatory Affairs will be responsible for the establishment and monitoring of budgets and timelines and will coordinate closely with other cross-functional development team members. Externally, the individual will interface with outside regulatory agencies and business partners regarding, regulatory and registration strategies.
- Develop and implement advanced and aggressive global regulatory strategies for multiple assets.
- Responsible for managing the tactical execution of preparation, review and submission of documents to the FDA and other regulatory authorities.
- Provide regulatory advice to multidisciplinary teams on the regulatory requirements to support clinical and nonclinical development, including preparation and maintenance of IND and CTA fillings
- In collaboration with team, perform/manage critical analyses of GXP related data and independently develop strategic/tactical interpretation and implementation
- Lead multidisciplinary teams in the development and execution of major regulatory documents such as Briefing Package and IMPD
- Lead, coordinate, write, critically review and provide input on regulatory filing documents (e.g., eCTD Module 2 summaries, integrated summary documents, Investigator’s Brochure, clinical study reports)
- Lead and facilitate activities to insure prioritized objectives are successfully delivered, including team preparation for meetings with FDA, EMA, and other regulatory authorities.
- Lead Regulatory Authority communications/interactions.
- Interface with global regulatory authorities and consultants as needed
- Maintain a a strong working knowledge of US, EU and ICH regulatory requirements in commercially relevant geographies; ability to apply knowledge both strategically and operationally to development projects in support of corporate goals.
- Proactively identify program issues and implement appropriate regulatory strategies to mitigate risk
- Oversee and ensure compliance with regulatory procedures and work practices
- Develop and implement regulatory operating guidelines/SOPs and common work practices/strategies within the team
- Insure support and recommend process improvements for internal regulatory documentation/tracking/archival systems
- Train, mentor and supervise regulatory employees, consultants/contractors in Regulatory Affairs
- Maintain a positive team spirit and lead by ethical principles
- Perform other responsibilities as may be required by Nurix, consistent with a growing, dynamic company.
- Domestic and international travel as required to establish/support vendor/ partner relationships to maximize the success of the programs (approx. 20%).
- Bachelor’s degree in a technical field with a graduate degree preferred.
- 15 years+ regulatory experience in pharmaceutical, biotech or specialty pharma companies. Oncology experience a plus.
- Regulatory Affairs Certification (RAC) preferredExperience with pharmaceutical, nonclinical, and clinical development of NCEs Experience with pharmaceuticals and biologics preferred; medical device experience is a plus.
- Demonstrated experience in the preparation and submission of INDs, CTAs, and NDAs and other global submission documents in support of clinical trials and marketing applications and their amendments in conformance with local regulatory requirements.
- Expert knowledge with GXP/ICH requirements and Guidance in major markets, especially US and EU
- Experience with labeling requirements is a plus
- Experience managing and coaching staff, able to motivate teams
- Excellent written and verbal communication skills. Strategic thinker, planner with excellent organizational skills
- Desirable to have experience in small biotech-flexibility to wear multiple hats as needed
- Ability to multitask, prioritize, and manage time efficiently in a fast-paced and entrepreneurial environment.
- Proven ability to effectively work collaboratively in cross functional environment