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Director/Sr. Director, Regulatory Affairs (Strategy, Immunology and Inflammation)

Nurix Therapeutics, Inc. is looking for a Director/Sr. Director in Regulatory Affairs to lead the regulatory strategy in immunology and inflammation. The ideal candidate will collaborate with internal stakeholders to ensure high-quality regulatory submissions and adherence to regulatory requirements.

Skills

  • Regulatory strategy expertise
  • Project management skills
  • Communication and interpersonal skills
  • Knowledge of drug development guidelines
  • Organizational skills

Responsibilities

  • Develop global regulatory strategy for immunology and inflammation
  • Manage global submissions such as IND, CTAs, and NDAs
  • Communicate with global Health Authorities including FDA and EMA
  • Work with cross-functional teams on submission plans
  • Track status and manage deliverables for regulatory submissions

Education

  • Bachelor's degree in life sciences or related field
  • Advanced degree preferred

Benefits

  • Competitive salary
  • Health benefits
  • Retirement plans
  • Professional development opportunities
To read the complete job description, please click on the ‘Apply’ button

Average salary estimate

$175000 / YEARLY (est.)
min
max
$150000K
$200000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Director/Sr. Director, Regulatory Affairs (Strategy, Immunology and Inflammation) , Nurix

If you are an experienced regulatory affairs professional passionate about immunology and inflammation, then Nurix Therapeutics, Inc. has an exciting opportunity for you as a Director/Sr. Director of Regulatory Affairs (Strategy, I&I) in beautiful San Francisco. In this role, you'll become a crucial member of our dynamic Regulatory team, where you'll step into the role of global regulatory lead, guiding the development of cutting-edge therapeutic areas in immunology and inflammation. Imagine collaborating closely with diverse internal stakeholders to shape global regulatory strategies, all while steering high-quality submissions to regulatory agencies. You’ll manage a variety of responsibilities, from working with CROs to deliver sound operational plans, to leading communications with global health authorities like the FDA and EMA. We are looking for someone who not only possesses in-depth knowledge of drug development regulations but also excels in project management, capable of navigating the complexities of regulatory submissions with skill and precision. At Nurix, embracing rigorous compliance while being proactive and solution-oriented is essential. You’ll also have the opportunity to participate in shaping the processes that define our success, ensuring that we adhere to all regulatory requirements while also focusing on long-term planning for expedited development needs. If you're ready to make a significant impact in the field of regulatory affairs, this position at Nurix is calling your name!

Frequently Asked Questions (FAQs) for Director/Sr. Director, Regulatory Affairs (Strategy, Immunology and Inflammation) Role at Nurix
What are the main responsibilities of the Director/Sr. Director of Regulatory Affairs at Nurix Therapeutics?

The Director/Sr. Director of Regulatory Affairs at Nurix Therapeutics is tasked with developing and implementing global regulatory strategies for immunology and inflammation therapeutic areas. This involves overseeing the preparation of clinical and nonclinical submissions, collaborating with cross-functional teams to ensure timely submission of documents to health authorities like the FDA and EMA, and leading initiative to anticipate and mitigate regulatory risks.

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What qualifications are required for the Director/Sr. Director, Regulatory Affairs role at Nurix Therapeutics?

Candidates for the Director/Sr. Director, Regulatory Affairs position at Nurix should possess a Bachelor's degree in a life sciences field, with advanced degrees preferred. A minimum of 12 years in regulatory affairs strategy, particularly in immunology and inflammation, along with strong project management skills and experience working directly with health authorities, is essential.

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How does the Director/Sr. Director collaborate with other teams at Nurix Therapeutics?

The Director/Sr. Director at Nurix Therapeutics collaborates closely with various internal teams, including clinical development and external partners like CROs. By representing Regulatory Affairs on development teams, the individual will ensure that regulatory strategies align seamlessly with organizational goals and timelines, facilitating successful project execution.

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What skills are necessary for success in the Director/Sr. Director, Regulatory Affairs position at Nurix?

To excel in the Director/Sr. Director role at Nurix, candidates should demonstrate strong organizational and communication skills, adeptness in project management techniques, and the ability to handle multiple projects simultaneously. A positive attitude and strong interpersonal skills are also crucial for fostering collaboration across diverse teams.

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What is the focus of the Regulatory Affairs team at Nurix Therapeutics?

The focus of the Regulatory Affairs team at Nurix Therapeutics is to develop innovative regulatory strategies that ensure the smooth progression of investigational drugs through clinical development, regulatory submission, and ultimately to market. The team works diligently to comply with all regulatory guidelines while aiming for timely approvals for new therapies.

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Common Interview Questions for Director/Sr. Director, Regulatory Affairs (Strategy, Immunology and Inflammation)
Can you describe your experience in developing global regulatory strategies?

When answering this question, highlight specific experiences where you crafted global regulatory strategies for clinical trials or filings. Share your thought process, collaboration with teams, and how you addressed challenges—this demonstrates your strategic thinking and leadership capabilities.

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How do you ensure compliance with FDA and EMA regulations during submissions?

Discuss your understanding of both FDA and EMA regulations, providing examples of how you have ensured compliance in past roles. You might mention utilizing checklists, engaging cross-functional teams for thorough preparation, and reviewing submissions meticulously before deadlines.

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What project management tools do you use when handling regulatory submissions?

Reference specific project management tools such as MS Project or Smartsheet. Describe how you've used these tools to track progress of submissions, manage timelines, and coordinate tasks across team members, which illustrates your organizational skills.

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Can you give an example of a regulatory challenge you faced and how you overcame it?

Provide a clear, concise example of a past regulatory challenge, focusing on your approach to resolving it. Explain the steps you took, how you communicated with stakeholders, and the final outcome to showcase your problem-solving skills.

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How do you maintain relationships with global health authorities?

Highlight the importance of transparency and regular communication. Discuss strategies such as proactive follow-ups, preparing for meetings, and building rapport, all of which foster trust and collaboration with health authorities.

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What do you consider when assessing regulatory risks?

Explain your approach to evaluating regulatory risks, including assessing historical precedents, understanding current regulations, and anticipating potential issues that could arise during vial submissions. This shows your analytical skills and foresight.

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How do you handle conflicting priorities in regulatory projects?

Showcase your ability to prioritize by describing a time when you managed conflicting deadlines. Highlight how you communicate with your team and stakeholders to adjust timelines and manage expectations effectively.

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In your opinion, what makes a successful regulatory submission?

Discuss the importance of thorough preparation, attention to detail, and collaboration across functions. Emphasize that a successful submission is a result of clear communication, adherence to guidelines, and pre-submission checks to minimize issues.

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What experience do you have with managing external consultants in regulatory affairs?

Talk about your past experiences managing external consultants or contractors, detailing how you established clear expectations, maintained open lines of communication, and ensured that their inputs aligned with your project's goals.

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How do you stay updated with current regulatory changes?

Explain your commitment to continuous learning by participating in workshops, networking with other professionals, and following regulatory news. Mention specific resources or platforms you use to remain informed, demonstrating your proactive approach to compliance.

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Nurix Therapeutics founded in 2009 and headquartered in San Francisco, California, develops therapies that control disease-causing proteins and develops drugs as treatments for hematologic cancers and immune-mediated diseases including immuno-onco...

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FUNDING
SENIORITY LEVEL REQUIREMENT
TEAM SIZE
SALARY RANGE
$150,000/yr - $200,000/yr
EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
January 10, 2025

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