Associate Director Regulatory Affairs

Our client is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Our client lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.

The Director, Regulatory Affairs, will be responsible for day-to-day regulatory activities of early/late phase investigational products, leads the writing and submission of IND/CTA/amendments and future marketing application submissions, provides guidance to the team on regulatory filings and responses, and provides critical regulatory intelligence and guidance back to the team. The AD, RA participates in a cross-functional team, partners with key internal/external team members/stakeholders, and partners with Regulatory CMC and Regulatory Operations to ensure the scientific data and submissions fulfills agency expectations in a compliant manner. This position will report to the Senior Director, Head of Global Regulatory Affairs

Key Responsibilities

Oversee regulatory activities for multiple programs within our client's development portfolio:

• Provide input and regulatory support to cross-functional development teams responsible for the translation, development and registration of our client's products
• Develop and execute regulatory strategy in support of overall program goals and objectives
• Provide day-to-day management of all regulatory aspects of ongoing and planned clinical development programs
• Lead the coordination, preparation and timely submission of regulatory documents and responses to queries from authorities (e.g., INDs, NIH/RAC submissions, BLAs, MAAs)
• Contribute to the development of regulatory content to support regulatory agency submissions
• Coordinate with external publishing resources for on-time delivery of high-quality regulatory submissions to regulatory agencies
• Establish relevant processes and procedures to support the Regulatory Affairs function activities
• Initiate and prepare regulatory agency correspondences to facilitate expedient and efficient product development and registration of assigned products
• Stay up-to-date on changes in regulatory guidelines and best practices that may impact our client’s product candidates
• Create plans to meet regulatory requirements, anticipate regulatory changes, build relationships with regulatory agencies, oversee regulatory submissions, and ensure compliance for our client's product candidates pre and post-approval

Key Requirements

• A Bachelor’s, Master’s or PhD in a scientific or medical discipline with a minimum of 6 years in Regulatory Affairs in a pharmaceutical, biotechnology, contract research organization (CRO) or related industry is required.
• Experience with leading major submissions and FDA meetings
• Demonstrated, hands-on experience, managing and preparing regulatory submissions especially Clinical Trial Applications outside of North America with a primary focus on European applications through the Clinical Trials Information System (CTIS).
• Demonstrated track record of successful clinical trial submissions in Canada, US, and Europe required.
• Strong competency in understanding global regulatory requirements and the emerging regulatory landscape.
• Balance strategic thinking and strong analytical skills with the ability to effectively execute in a prioritized manner.
• Detail oriented with excellent written and verbal communication and presentation skills.
• Ability to work independently and collaboratively, as required, with a high degree of flexibility in a fast-paced, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.