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Sr. Director, Regulatory Affairs - CMC

1 month, 2 weeks ago
United States
Full-time
Lead
Compliance Manager
Legal
Apply Now
bridgebiowp

bridgebiowp

bridgebiowp is a biotechnology firm focused on designing transformative medicines specifically for patients suffering from genetic diseases and cancers that have identifiable genetic drivers.

Pharmaceuticals
251-1K
Founded 2014
$2300M raised
View All Jobs 15

Description

  • Lead CMC regulatory strategy, planning, and execution for IND/CTA, NDA/MAA, post-approval submissions, and global registrations.
  • Partner with CMC, Quality, Regulatory Operations, and other stakeholders to deliver timely, high-quality regulatory submissions.
  • Provide strategic guidance on CMC regulatory risks, change controls, health authority interactions, and submission strategy.
  • Coordinate and review responses to CMC-related health authority requests and ensure regulatory conformance of technical and manufacturing documentation.
  • Ensure labeling content, validation activities, and quality documentation support regulatory requirements.
  • Mentor and coach junior team members and provide oversight for vendors and assigned staff as needed.
  • Apply AI-enabled tools and digital technologies to improve the efficiency, quality, and consistency of regulatory deliverables.
  • Contribute to global regulatory activities, including ROW filings and regional filing strategies across MENA, LATAM, and APAC.

Requirements

  • BA/BS degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or a related scientific discipline required; advanced degree preferred.
  • Extensive Regulatory Affairs CMC experience in the biotechnology and/or pharmaceutical industry.
  • Experience supporting NDA/MAA submissions for new chemical entities in pre- and post-approval environments.
  • Demonstrated experience leading complex global regulatory submissions, including Rest of World regions such as MENA, LATAM, and APAC.
  • Strong knowledge of global health authority regulations, CMC development, manufacturing processes, and quality documentation standards.
  • Proven ability to lead through influence in a matrixed organization with strong cross-functional collaboration, strategic thinking, project management, communication, and problem-solving skills.
  • Demonstrated experience mentoring, coaching, and developing others; prior direct people management experience is preferred but not required.
  • Demonstrated experience using AI-enabled or digital tools to improve efficiency, quality, or decision-making in regulatory or technical workflows while maintaining compliance.
  • Ability to travel approximately 10–20% as needed.
  • U.S.-based remote role with quarterly, or as-needed, visits to the San Francisco office.

Benefits

  • Market-leading compensation with a salary range of $285,000 to $320,000 USD in California.
  • Annual performance bonus and company equity.
  • 401(k) with employer match.
  • Employee Stock Purchase Program (ESPP).
  • Pre-tax commuter benefits for transit and parking.
  • 100% employer-paid medical, dental, and vision premiums for employees and dependents.
  • Health Savings Account (HSA) with annual employer contributions plus Flexible Spending Accounts (FSA).
  • Fertility and family-forming benefits.
  • Expanded mental health support, including therapy and coaching resources.
  • Flexible hybrid work model and flexible, “take-what-you-need” paid time off with company-paid holidays.
  • Comprehensive paid medical and parental leave.
  • Career development resources, including LinkedIn Learning, LifeLabs, and BetterUp Coaching.

Interested in this position?

Apply directly on the company website

Apply Now

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