Reporting to the Chief Medical Officer, the new Vice President, Regulatory Affairs, will lead global strategic regulatory direction as the company hits a pivotal point of development. The role will be responsible for planning and executing program applications in the US and Europe, as well as hold accountability for regulatory submissions, applicable communications, and compliance across the company’s new and established programs.
S/he will influence decision making and strategy for the Company, requiring expertise in compliance, assessment, and leadership spanning the support of existing and potential partnerships.
The ideal candidate will be a strong, collaborative leader who brings a tactile and strategic approach to projects spanning the clinical development process.
Job Responsibilities include, but are not limited to:
- In conjunction with CMO and Project Teams, facilitate rapid and effective clinical trial applications, marketing authorizations, and extensions; or variations for assigned products
- Provide advice and guidance to Company staff regarding regulatory aspects of drug development. This includes providing regulatory guidance and expertise to project teams in the design and conduct of preclinical studies and clinical trials
- Give strategic direction to Regulatory Affairs department; including mentoring and leading staff
- Provide regulatory leadership and support to project/program teams and Senior Management for all aspects of the development program (nonclinical, clinical and quality (CMC)
- Effectively communicate requirements and compliance obligations under laws, regulations, and guidance in the US and Europe
- Direct and negotiate submissions (IND, NDA, BLA etc..) and approvals with regulatory authorities both in the US and Europe
- Guide and/or lead regulatory agency interactions, including communications and meetings
- Strategize, lead, write and/or supervise the development of and submission of documents/dossiers to regulatory agencies to achieve development goals
- Oversee the regulatory activities at CROs, providing document review in order to ensure the quality and scientific integrity of documents submitted to regulatory authorities
QUALIFICATIONS
The successful candidate will be an established Regulatory leader who thrives in a fast paced, collaborative environment with a strong track record of hands-on experience in Regulatory submissions.
(S)he will have the following mix of personal and professional characteristics:
- Advanced degree in a scientific discipline (M.S., Ph.D., PharmD) preferred, with at least 10 years of relevant regulatory experience; other degrees will be considered with appropriate experience
- Proven success in delivering effective global regulatory strategies in coordination with clinical plans and marketing objectives leading to successful registration
- Diverse experience in development and regulatory activities in support for product registration and maintenance, especially with outside partners/vendors
- Experience leading cross functional teams
- Excellent in communicating regulatory strategy, issues, and risks in written and verbal format.
- Proven success in communicating to and negotiating with FDA and global health authorities
- Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Product Development and Commercialization process
- Understanding of policy, laws, regulations, and guidelines as they apply to Regulatory Agencies for drug development and approval
- Experience utilizing leadership techniques to drive a team through all stages of product development
- Self-starter, independent and a practical thinker
- Experience in orphan and rare diseases preferred
- Some experience in pediatrics also preferred but not a necessity