Job Details

Overview

I am representing a clinical stage biopharmaceutical company seeking a strategic and experienced regulatory leader to join as Head of Regulatory Affairs. This role will be instrumental in shaping and executing global regulatory strategies across an RNA-targeted therapeutics portfolio. The ideal candidate will bring deep expertise in regulatory submissions, interactions with health authorities, and lifecycle management from early development through approval. You will collaborate cross-functionally to ensure regulatory compliance and drive successful development programs in alignment with corporate goals.

Responsibilities

• Lead global regulatory strategy and lifecycle management for the RNA-targeted therapeutics portfolio.
• Drive regulatory submissions and approvals (e.g., INDs, NDAs/BLAs) and coordinate interactions with health authorities (FDA and international agencies).
• Provide strategic regulatory leadership across development programs and ensure compliance with regulatory requirements.
• Collaborate cross-functionally with internal teams to shape development plans and align regulatory expectations with corporate goals.

Qualifications

• Proven track record of leading regulatory teams and managing complex regulatory submissions (INDs, NDAs/BLAs) from early development through approval.
• Extensive experience interacting with FDA and international regulatory agencies.
• Strong strategic thinking, leadership, and cross-functional collaboration skills.
• Experience in RNA-targeted therapeutics or closely related modalities is preferred.

EEO Statement

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Benefits

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit plain text: www.realstaffing.com