Executive Director, Regulatory Affairs

1 month ago

Malvern, Arkansas, United States Venatorx Pharmaceuticals Inc Full time

Position Description

The Executive Director of Regulatory Affairs is responsible for providing overall leadership to ensure the development and execution of regulatory strategies and plans to enable efficient global development of products in the portfolio. (S)he is tasked with providing ongoing analysis of regulatory risks and opportunities in the development programs and proposing innovative approaches to mitigate/resolve risks and leverage opportunities to the benefit of the company's development efforts. (S)he will also be accountable for effective regulatory submissions and communications/meetings across these territories, as well as developing the in-house and contracted infrastructure and capability to maintain compliance with all regulatory requirements applicable to the company's programs.

The Executive Director of Regulatory Affairs will be the regulatory leader for one or more of the company's drug development programs and will work closely with Medical, Research & Development, Technical Operations, Quality, and other disciplines to ensure an effective linkage of regulatory strategy, regulatory requirements, and the timely submission and approval of regulatory filings.

Responsibilities include:

Provide regulatory leadership and support to project/program teams and Senior Management for all aspects of the development program (nonclinical, clinical, quality (CMC) and labeling)Effectively communicate requirements and compliance obligations under laws, regulations, and guidance in the US and around the worldDevelop and maintain regulatory affairs infrastructure including development of departmental policies and proceduresDirect and negotiate submissions (IND, CTA, NDA, MAA, etc..) and approvals with regulatory authoritiesGuide and/or lead regulatory agency interactions, including communications, meetings, and responses to information requestsStrategize, lead, write and/or supervise the development of and submission of documents/dossiers to regulatory agencies to achieve development goals; ensure on-time, high-quality and regulatory–compliant submissionsLead and manage the compilation and submission of new Investigational Drug Applications (INDs) and Clinical Trial Applications (CTAs).Contribute to the creation of the overall product development strategy and manage the development, monitoring and delivery of regulatory project plans throughout the lifecycle Facilitate cross-functional writing of nonclinical reports, IND sections, protocols, etc. supporting regulatory submissions etc., as well as write and edit documents as needed. Assume responsibility for IND maintenance, including routine and more substantial IND amendments.Coordinate and lead communication with the relevant personnel at the FDA.Support the preparation and conduct of Agency meetings as necessary, including preparation and coordination of meeting requests and briefing packages.Support late-stage development, including supporting the development of NDA/MAA and other global filing plans.Manage contract staff and vendors as needed to support regulatory activities.Collaborate closely with external partners to enable them to achieve their regulatory objectivesCoordinate with Regulatory Operations in the generation of documents suitable for electronic filings. Qualifications Advanced degree in a scientific discipline (M.D., Ph.D., PharmD) preferred, with at least 15 years of relevant regulatory experience; other degrees (B.S., M.S., MBA) will be considered with appropriate experience.Experience supporting both early and late phase development, including development and filing of associated regulatory submissions.Experience managing and collaborating with outside partners/vendorsAbility to collaborate effectively with internal and external key stakeholdersAbility to review, understand, and explain the regulations and guidance documents to guide project teams,Proven success in communicating to and negotiating with FDA and global health authorities and managing clinical trial applications in several geographies around the world (for example US, Europe, Latin America, Asia)Ability to drive meetings with various stakeholders including senior management, regulatory agencies, expert advisors, external partners/collaborators and project teamsAbility to comprehend and operate at high levels to address general issues and dig in deep to evaluate and address specific grass root issuesPassion, self-starter, outcomes-oriented, and innovative thinkerOutstanding written, oral, organizational, and interpersonal skills are required for this highly collaborative role. This is a representative description of the job and is not intended to be all-inclusive. Employee may perform other related duties as required to meet the ongoing needs of the organization. Duties, responsibilities, and activities may change at any time with or without notice. Venatorx is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law. For more information, please check out our website:

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