Manager/Sr Manger/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) - Remote
8+ years
Not Disclosed
10
March 4, 2025
Job Description
Job Type:
Full Time
Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science
Skills:
Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding
Manager/Sr. Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) - Remote
Company: Nurix Therapeutics
Location: San Francisco, Remote
Posted: 30+ days ago
Job Summary:
Nurix Therapeutics, Inc. is seeking a Manager/Sr. Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology) to join the Regulatory team. The successful candidate will be responsible for helping build and execute global regulatory strategy, guiding regulatory submissions, and ensuring compliance with global regulatory authorities. This role involves cross-functional collaboration to support clinical development, regulatory submissions, and product lifecycle management.
Responsibilities:
- Provide regulatory strategic direction and support for assigned global development programs.
- Assist senior Regulatory Affairs staff with development program activities and deliverables.
- Design and implement regulatory strategies to obtain and maintain product investigative and marketing applications.
- Act as a regulatory representative on early and/or late-phase clinical studies.
- Respond to inquiries from global regulatory authorities and support regulatory meetings.
- Prepare and maintain regulatory documents, including Annual Reports, DSURs, Investigator’s Brochures, INDs, CTAs, and NDAs.
- Catalog and maintain regulatory application submissions.
- Conduct research on regulatory requirements and emerging industry trends.
- Ensure product compliance throughout the development lifecycle.
- Monitor and assess regulatory risks, developing mitigation strategies.
- Oversee quality assurance processes to ensure regulatory compliance.
- Review Standard Operating Procedures (SOPs) related to Regulatory Affairs.
- Develop submission plans and track major submission deliverables.
- Manage consultants and contractors as needed.
Experience and Skills:
- Education: Bachelor's degree in life sciences or a related scientific discipline (advanced degree preferred).
- Experience: Minimum of 8 years in regulatory affairs strategy.
- Strong knowledge of drug development, FDA, EMA, and ICH guidelines and regulations.
- Experience supporting clinical trial and marketing applications to regulatory authorities.
- Ability to analyze scientific and technical information and communicate regulatory affairs requirements.
- Proven ability to manage multiple projects and resolve regulatory issues.
- Strong project management and critical thinking skills.
- Experience using project management tools (e.g., MS Project, Smartsheet, Excel trackers).
- Excellent organizational, written, and verbal communication skills.
- Ability to work independently and collaboratively in a team environment.
- Positive attitude, proactive mindset, and strong interpersonal skills.
Privacy Policy:
By applying for this position, you agree to Nurix Therapeutics' collection and use of personal information as described in their Privacy Policy.
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