Senior Manager/Associate Director, Regulatory Affairs

What You’ll Do

We are looking for a talented and motivated regulatory affairs leader to help develop and execute regulatory strategies aimed at the most efficient regulatory pathway for development programs. This involves collaboration with cross-functional project teams in planning development strategies and leading global regulatory submissions for assigned projects. The candidate will have demonstrated the ability to work independently or with limited oversight, along with knowledge of regulatory requirements and guidelines, and will apply that knowledge to daily work while managing critical projects as part of an interdisciplinary team. Level (Senior Manager or Associate Director) will be determined by experience and scope of responsibility.

Responsibilities

• 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

Education, Experience & Skills Requirements

• BA/BS degree in the biological or physical sciences, advanced degree (eg, PharmD or PhD preferred);
• Relevant pharmaceutical industry experience, including experience in regulatory affairs; a minimum of 3 years of industry experience is generally required for the Senior Manager level, with greater experience and scope of responsibility expected at the Associate Director level. An equivalent combination of education and experience may be considered.
• Knowledgeable of US FDA and international pharmaceutical guidance, regulations (e.g., 21 CFR, ICH, GCP, GMP, EMA), drug development process, and industry-standard practices
• Demonstrated experience supporting eCTD-formatted submissions, e.g., INDs, NDAs/BLAs, MAAs, annual reports, amendments, and supplements
• Has successfully coordinated or supported responses to health authorities or other critical submission projects while maintaining agreed timelines
• Proficient in written, oral, and interpersonal communications in English
• Ability to work in close collaboration with colleagues in the regulatory department and throughout the development organization
• Capability to provide strategic guidance on regulatory and program-related issues
• Ability to problem solve unexpected problems or roadblocks that arise
• High attention to detail; ability to organize, prioritize, and delegate assigned projects
• Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations preferred
• Proficient user of standard MS Office suite (e.g., Word, Excel, PowerPoint), experience using Veeva electronic document management systems and document review tools

Where You’ll Work

This is a U.S.-based remote role that will require occasional, as-needed travel to our San Francisco or Palo Alto offices.