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1 - 25 Results of 125
Bolt Biotherapeutics
Redwood City, California, United States
2 days ago

Description

Who We Are

Bolt Biotherapeutics, based in the San Francisco Bay Area, is a private clinical-stage biotechnology company developing Boltbody™ Immune-stimulating Antibody Conjugates (ISACs), a new class of immuno-oncology therapeutics that have eliminated tumors following systemic administration in preclinical studies while also developing immunological memory, which may lead to more durable clinical responses for patients. This is a unique opportunity to join and build, with like-minded colleagues, a company that will transform the lives of individuals with cancers. We are an Equal Opportunity Employer offering a competitive salary and benefits package. Applicants should be legally entitled to work for any employer in the US. Note to Employment Agencies: Please do not forward any agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited.

The Position

The Sr. Director, Global Regulatory Affairs will be responsible for building a regulatory affairs department from the ground up while also playing a hands-on role as the global regulatory leader for Bolt’s lead program.   The successful candidate will develop innovative U.S. and global regulatory strategies and filings that will advance Bolt’s immuno-oncology products for patients. This includes the development and implementation of strategy, ensuring timely preparation, engagement with regulatory authorities (including, review and submission of documents), and maintaining strict compliance with relevant requirements. This person will represent the regulatory function on cross-functional teams and must integrate company goals into the objectives and activities of the department. This position will help guide development programs, anticipate changes in the regulatory environment and approval requirements, and communicate effectively within the team. The individual will serve as a credible, influential, respected corporate spokesperson during interactions with regulators and regulatory agencies and will provide mentoring and leadership for cross-functional team members during interactions with regulatory authorities.



Requirements

About You

You have previous experience building and leading a team of regulatory professionals.  You have proven experience in the development and implementation of innovative global regulatory strategies that maximize the likelihood of rapid development and timely registration of oncology products. You have led and overseen regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance.  Your colleagues have counted on you to provide regulatory guidance including identifying and assessing regulatory risks, mitigations, and contingencies. You are known for your attention to detail and ensuring sound regulatory practices are fully integrated into all pre-clinical, clinical and technical submissions.  Your science degree and previous work experience has prepared you to evaluate all documents submitted to the regulatory agencies to ensure they are complete, well organized and scientifically accurate.  You enjoy rolling up your sleeves and writing and reviewing sections of all regulatory submissions (INDs, BLAs, CTAs, meeting requests, briefing documents) to support clinical trials and product registration.  You have been commended in the past for your ability to interact with the FDA and global regulatory agencies including facilitating regulatory meetings.

Job Information

  • Job ID: 54720194
  • Location:
    Redwood City, California, United States
  • Position Title: Sr. Director, Global Regulatory Affairs
  • Company Name: Bolt Biotherapeutics
  • Industry: Biotechnology
  • Job Function: Other
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 5-7 Years
  • Required Travel: 0-10%
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