Executive Director/VP Regulatory Affairs

Job Title: Executive Director/VP Regulatory Affairs

Job Number: 35588

Location: Remote, 

Job Description

The Exec Dir / VP, Regulatory Affairs will be responsible for leading the development and implementation of a consolidated regulatory strategy to secure and maintain market access for the assigned product in a specific indication. The ED/VP is also responsible for establishing and maintaining effective relationships with regulatory agencies, especially the FDA. This role will participate as a core project team member and will manage personnel that prepare the regulatory submissions and interact with Core Team members, agencies/health authorities to obtain and maintain product approvals.

Responsibilities

• Develop and implement regulatory strategy for assigned projects.
• Regulatory Affairs representatives for Project Team.
• When assigned, supervise one or more Regulatory Affairs staff, be responsible for their professional development and support their outputs as defined by departmental goals and deliverables.
• Serve as the primary interface for FDA on assigned projects.
• Communicate project regulatory strategies and plans to management, cross functional teams and any partners/collaborators to establish alignment.
• Lead the preparation of regulatory submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications etc.
• Work with functional groups to define contribution for submissions.
• Prepare company team for FDA and other health agency meetings, as required.
• Serve as the primary interface with CROs for coordination and preparation of Health Authority submissions.
• Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.
• Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance’s, and current industry practice.
• Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.

Required Skills

• Bachelor’s degree in scientific discipline; advanced scientific degree preferred with 15+ years pharmaceutical industry experience, including 10+ years in Regulatory Affairs.
• Experience in multiple phases of development in relevant therapeutic areas. Experience in pulmonary and cardiovascular diseases a plus.
• Significant experience in drug development including product approval/launch.
• Demonstrated experience in preparing FDA submissions including NDAs or BLAs and experience with global dossiers. Experience with eCTD content and format for regulatory submissions.
• Knowledge of the drug development process and global submission process.
• Knowledge of global regulatory requirements as they relate to the overall global regulatory strategy.
• Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
• Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
• Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail.
• Prior experience with drug/device combinations products
• Proven ability to build partnerships with senior key stakeholders from other functions to ensure that the strategic business goals are met through sharing of knowledge and expertise.
• Domestic and occasional international travel required (20%).