Senior Manager/Associate Director, Regulatory Affairs

Skill Development & Career Paths

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

• Develop and execute regional regulatory strategies in support of development programs.  Provide regional regulatory guidance and strategy for support of product development and registration strategies, including broad regulatory oversight for nonclinical/clinical development

• Plan, compile, review, and submit regulatory documents, including initial INDs/CTAs/NDAs and amendments or supplements, independently or with limited oversight
• Represent Regulatory at cross functional team meetings.
• Lead study related regulatory activities:
  • Act as the regulatory study representative at cross-functional team meetings
  • Provides strategic regulatory guidance internally on study-level decision-making
  • Keeps study team informed of regulatory activities in the context of study team management meetings
  • Provides ownership of study-level global regulatory activities, including clinical trial application (CTA) and IND submissions, reviews and approval of investigator document packages and associated FDA submissions, and manages other regulatory aspects of the study as necessary.
  • Manage tracking of regulatory/ethics submissions and approvals across all studies
• Facilitate FDA or other Health Authority meetings in collaboration with Regulatory leadership.
• Collaborate with Project Team representatives in the planning of regulatory documents; support processes by which regulatory submissions are reviewed, finalized, and signed-off.
• Develop, maintain, and communicate timelines for regulatory submissions to ensure timely delivery of regulatory documentation
• Participate in the review of critical documents such as protocols, ICFs, IBs, CSRs, and DSURs to ensure compliance with relevant regulations and guidance (e.g., ICH, FDA, EMA) before submission
• Coordinate with CROs and other vendors to plan and finalize submissions to health authorities per regulations and guidelines
• Manage and track queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses, and provides periodic status updates regarding unfulfilled conditions/commitments
• Input to global regulatory submissions and strategic planning as applicable
• Contribute to the maintenance of regulatory databases, including submission and correspondence logs
• Review, write, and present regulatory guidelines and SOPs as needed to support high-quality submissions and adherence to regulatory requirements
• Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration

Financial & Rewards

• Market-leading compensation

• 401(k) with employer match

• Employee Stock Purchase Program (ESPP)

• Pre-tax commuter benefits (transit and parking)

• Referral bonus for hired candidates

• Subsidized lunch and parking on in-office days

• 100%

  100% employer-paid medical, dental, and vision premiums for you and your dependents

• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)

• Fertility & family-forming benefits

•  Expanded mental health support (therapy and coaching resources)

• Hybrid work model with flexibility

• Flexible, “take-what-you-need” paid time off and company-paid holidays

• Comprehensive paid medical and parental leave to care for yourself and your family