Director, Regulatory Affairs

Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer.

The Director of Regulatory Affairs will report to the Senior Vice President Regulatory Affairs and will drive the implementation of regulatory strategies in collaboration with US and EU regulatory leads. The ideal candidate will possess strong strategic thinking capabilities, a high level of accountability, and the ability to prioritize effectively. This role requires a hands-on approach as an individual contributor, with a focus on both high-level strategy and diving into the details to ensure seamless execution.

RESPONSIBILITIES:

• Responsible for strategic and operational regulatory input and support for collaboration with other project team members, including regulatory team members.
• Contributes to the development of global regulatory plans and strategies, identifies and proposes risk mitigation strategies to facilitate the progress for assigned programs in all phases of development.
• Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
• Serve as the Regulatory Affairs representative on assigned project teams and assure the progress of projects by providing direction, solutions and feedback to the teams in support of regulatory approvals.
• Prepares and/or manages submissions that may be technically complex and require extensive interaction with departments outside of regulatory affairs.
• Provide regulatory advice and information to cross-functional teams and to other functional areas (i.e., CMC, nonclinical, and clinical) for product development and planning to support the timely achievement of company and department goals.
• Leads the drafting, review, and finalization of responses to queries from Regulatory Authorities.
• Maintain awareness of current regulatory requirements and communicate requirements in support of regulatory approvals.
• Maintains knowledge of regulatory requirements up to current date and communicates changes in regulatory information to other departments.
• Establish and meet timelines for regulatory submissions related to INDs/CTAs, including nonclinical, clinical, and CMC activities, while planning for global NDAs / MAAs.

EDCUATION & PROFESSIONAL EXPERIENCE:

• A degree in life science, chemistry, chemical engineering, or a closely related discipline (graduate degree preferred), with at least 10 years of experience in biotechnology/pharmaceutical regulatory affairs. Experience in a fast-paced, small company environment & Hematology Oncology/Oncology experience is preferred.
• Regulatory Submissions & Approvals: Proven track record of drafting, reviewing, and finalizing successful regulatory submissions (e.g., IND/CTA, NDA/BLA/MAA), with direct experience in pharmaceutical regulatory submissions and product approvals. Strong knowledge of FDA regulations, ICH guidance, and global health authority practices across the US and Europe (UK experience is a plus).
• Skills & Proficiency: Strong proficiency in MS Word, Excel, PowerPoint, Visio, Adobe Acrobat, and document formatting templates. Excellent verbal, written, negotiation, and interpersonal communication skills, with the ability to engage effectively with internal teams and external audiences at all levels.
• Project & Team Management: Demonstrated ability to manage multiple complex projects, prioritize workloads, and adapt to changing circumstances. Proven leadership in managing regulatory activities and leading cross-functional teams. Ability to work independently and influence others, with prior management experience a plus.
• Strategic Guidance & Collaboration: Experience providing strategic advice on integrated regulatory development plans and lifecycle management. Strong collaborative, analytical, and interpretative skills to review and compile reports and documents for regulatory submissions.
• Regulatory Agency Interactions: Extensive experience leading regulatory agency interactions, with a focus on successful management and communication with global regulatory bodies.

The salary range for this position is $220,000 - $250,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.