Associate Director, Regulatory Affairs (Contract) - The Steely Group

We are seeking a driven and talented individual to join our client's Regulatory team. You will provide regulatory support in development and execution of regulatory strategies in support of the global clinical trial applications, marketing authorizations, and life cycle management of an expanding oncology portfolio in compliance with applicable regulatory requirements. You will also lead interactions with global Health Authorities and serve as a regulatory representative on cross-functional development teams. Experience in oncology drug development is strongly preferred. While collaborating with cross-functional departments, you will play a key role in maximizing the client's technology and progressing their novel therapeutics.  

Responsibilities:

• Drives the global regulatory strategy for Oncology antibody-drug conjugates starting from First-in-Human studies to registration-enabling clinical trials.
• Leads the preparation, review and planning of submissions to regulatory agencies including FDA, EMA, and other global Health Authorities to support the approval of clinical trial and marketing applications, and is responsible for the maintenance of these applications (INDs, CTAs, BLAs, MAAs).
• Oversees submission of meeting requests, briefing documents, and responses to questions and leads preparation activities and discussion for FDA meetings and EMA Scientific Advice.
• Ensures regulatory documents are developed with high quality, delivered in a timely manner, are consistent with corporate strategy and compliant with current global regulatory requirements.
• Provides regulatory advice to the cross-functional development teams to ensure that the development plan is aligned with current global regulations.
• Leads collaboration with CROs for global regulatory submission planning and execution.
• Works with regulatory operations to develop submission plans and timelines.
• Monitors, analyzes, and disseminates intelligence on regulatory matters that may affect ongoing development programs.

Qualifications:

• Bachelor’s degree Life/Health Sciences; Master’s degree and/or Ph.D. a plus
• Minimum of 10+ years of experience in pharmaceutical / biotech with minimum of 5 years in Regulatory Affairs
• Experience leading FDA interactions required
• Expertise in Clinical Trial Application submissions and approvals in Latin America, Asia-Pac, and EU (under CTR) preferred
• Knowledge of US and international regulations as they apply to drug and biologic development, particularly in Oncology and rare diseases
• Demonstrated experience managing development of INDs and global clinical trial applications
• Experience leading regulatory agency interactions (FDA meetings, EMA Scientific Advice, Advisory Committees, Oral Explanations, etc.)
• Strong technical and analytical skills with ability to make data-driven decisions
• Strong written and oral communication skills
• Strong leadership, negotiation, and collaboration skills