The Role:

In this newly created position, the Director of Global Regulatory Affairs will be responsible for driving and implementing worldwide regulatory strategies and tactics across the development pipeline for applicable programs. 

The position will be responsible for overseeing global development strategy and regulatory operations for their respective program(s), as well as managing development of clinical and regulatory documents for inclusion in global submissions. This position involves both strategic planning, supporting interactions with regulators and vendor oversight/collaborative partners, as well as hands-on responsibilities.

Responsibilities:

• Develop and drive regulatory strategy and plans for quality and timely submissions.
• Provide regulatory guidance regarding FDA and ex-US regulatory requirements for global clinical development to support trials and future registration.
• Oversee/collaborate on preparation, review, and submission of regulatory documents, maintaining compliance with regulatory requirements.
• Support the organization in conducting regulatory health authority (RHA) meetings. Coordinate and contribute to writing and reviewing various RHA documents/briefing packages to support formal meetings.
• Compile, review, and submit clinical trial and marketing/registration applications, amendments, and supplements.
• Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
• Provide strategic guidance for and author applications related to designations for expedited programs (e.g., Fast Track, Breakthrough, Prime) or other designations such as Orphan.
• Provide support for regulatory review of publications and clinical trial materials.
• Provide innovative solutions while being an advocate for compliance.
• Assist with SOP generation.
• Perform other duties as required, interfacing with other departments, CROs, and external vendors as needed.
• Provide support for regulatory initiatives aimed at initiating global clinical trials .
• Proficiency with regulatory information management systems (e.g., Veeva RIM), eCTD publishing tools.

Competencies Include:

• Ability to work independently and successfully in a fast paced environment, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues and balance competing priorities effectively.
• Ability to foster effective relationships and collaboration, motivate others, and influence without authority.
• Excellent attention to detail.
• Excellent organization, communication, and multi-tasking skills.

Qualifications:

• S/M.S. in related field or related experience.
• 10 years of work experience in a pharmaceutical/biotech regulatory affairs role with deep ep experience & knowledge in all regulatory aspects of clinical development.
• Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development in the US and EU; APAC is a plus.
• Experience submitting INDs, NDAs/BLAs; ex-US CTAs (CTIS a plus), MAAs.
• Expert knowledge of the current regulatory environment.
• Excellent verbal and written communication skills with ability to positively impact and influence peers and team.
• Experience in a matrixed environment, effectively communicating and managing projects cross functionally.
• Experience in a fast-paced, small company environment.
• Ability to accommodate flexible working hours to support business relationships in different time zones.
• Up to 10% domestic and international travel may be required.
• Experience working in oncology.
• Pediatric experience is a plus.
• Strong written/oral communication skills.