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Sr. Director / Exec. Director, Reg Affairs

3 hours, 2 minutes ago
United States
Full-time
Lead
Program Manager
Project and Program Management
Agile
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 38

Description

  • Create and execute proactive global regulatory strategies for product development, approval, and registration.
  • Apply global quality and regulatory standards and guidelines across programs to ensure requirements are met.
  • Partner with senior leadership to align regulatory plans with short- and long-term company objectives.
  • Own regulatory submission deliverables and ensure timely, high-quality execution.
  • Represent regulatory affairs in senior management discussions and communicate strategies, recommendations, and risks.
  • Lead, mentor, and develop the affiliate regulatory strategy team and other regulatory staff as needed.
  • Guide and oversee critical global regulatory submissions from pre-IND through post-marketing to the FDA, EMA, and other health authorities.
  • Serve as the primary liaison with regulatory authorities and manage key health authority interactions.
  • Direct internal staff and external regulatory consultants to support compliance with U.S. and international requirements.
  • Monitor and communicate regulatory guidance, regulations, and industry best practices to inform the company.
  • Support due diligence and partnering activities as needed.

Requirements

  • Bachelor's degree in a scientific field is required.
  • Advanced degree in MD, Ph.D., PharmD, or MS is preferred.
  • 15+ years of relevant pharmaceutical or biotechnology regulatory affairs experience.
  • Experience leading a Regulatory Affairs group in the pharmaceutical industry.
  • Strong understanding of the drug development process, regulatory requirements, and underlying science.
  • Excellent written and verbal communication skills.
  • Excellent project management skills with the ability to manage multiple priorities.
  • Ability to rapidly analyze complex problems and situations.
  • Ability to lead teams under tight timelines and contribute to day-to-day operations as needed.
  • Strong interpersonal skills and the ability to influence without authority and work effectively across all levels of management.
  • Experience consulting with internal and external business stakeholders.
  • Willingness to travel to key meetings and Health Authority interactions as needed.
  • Demonstrated curiosity and adaptability in adopting AI-powered tools and technologies.

Benefits

  • Market-leading compensation with base pay and an annual performance bonus.
  • Company equity and employee stock purchase program.
  • 401(k) with 100% employer match on the first 3% and 50% on the next 2%.
  • Comprehensive health coverage with 100% of medical, dental, and vision premiums covered for employees and dependents.
  • Mental health support through Spring Health, including therapy and coaching sessions.
  • Hybrid/remote work flexibility with quarterly in-office collaboration.
  • Unlimited flexible paid time off plus company-paid holidays.
  • Paid parental leave and fertility/family-forming benefits.
  • HSA with annual employer contributions, FSA options, and other pre-tax benefits.
  • Subsidized lunch and parking on in-office days.
  • Professional development and career pathing through LinkedIn Learning, LifeLabs, BetterUp, regular feedback, and internal mobility opportunities.

Interested in this position?

Apply directly on the company website

Apply Now

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