Executive Director, Regulatory Affairs

Responsibilities

• Provide clinical regulatory expertise and leadership to ensure the Company builds credible and trustworthy relationships with health authorities based upon the submission of scientifically meritorious data and in conformance with quality standards.
• Interacts with FDA and other international regulatory agencies as needed, on a proactive, independent, and frequent basis.
• Adequately communicate company views to agencies.
• Supervise, manage, and collaborate with external service vendors, contractors, and consultants as needed.
• Obtain, generate information and documents to be submitted to regulatory authorities; prepare effective planning timelines, and liaise with team contributors for the preparation of required regulatory documents and submissions.
• Provide regulatory subject matter expertise during the review of documentation, protocols, and reports received.
• Prepare additional written materials as needed.
• Review and interpret regulatory rules as they relate to Company products and procedures, clinical studies, testing, or record-keeping and ensure they are communicated through Company policies and procedures.
• Recommend and implement compliance strategies for existing and proposed products and activities.
• Take a leadership role in the development of regulatory functional infrastructure and business operations, e.g., electronic documentation management systems/archiving, electronic publishing systems, documentation template development; serve as primary owner for Regulatory Affairs Standard Operating Procedures (SOPs).
• Serve as backup to the Vice President, Regulatory Affairs on assigned core teams as needed; assist in submission risk assessment process.
• Handle various project budgets, as assigned.
• Occasional domestic and international travel.

Requirements

• Bachelor of Science degree in a science-related field (with an advanced scientific degree preferred).
• 10+ years of relevant experience in a regulated drug environment is required.
• The ideal candidate will also have management experience.
• In-depth understanding of regulations and guidelines governing all phases (pre-IND through post-approval) of drug development and working knowledge of US and ex-US regulations and practices pertaining to the development, manufacture, testing, and distribution of pharmaceutical.
• In-depth understanding of clinical regulatory requirements for clinical trials and marketing applications particularly for key countries ex-US such as EU, UK, Canada, Australia, and Asia.
• In-depth understanding of regional/country-specific clinical regulatory requirements for launch requirements and post-approval life cycle management particularly for key countries ex-US such as EU, UK, Canada, Australia, and Asia.
• A demonstrated track record of successful regulatory filings e.g. IND/CTAs, NDA/BLA/MAAs is essential, with the ideal candidate having done several INDs and at least one registrational filing.
• Experience with bringing regulatory projects to commercialization is of value.
• Demonstrable experience in successfully developing and managing regulatory submissions, review, and preparation of scientific/technical/clinical responses to agency questions.
• Good understanding of pharmaceutical development, clinical research, and the regulatory environment.

Preferred Qualifications

• Previous experience in leading a team to prepare for major regulatory agency interactions, such as FDA pre-NDA, EOP2 meetings, advisory committee meetings, and/or EU oral explanations/scientific advice.
• Experience with the electronic submission process (e.g., Veeva RIM System or equivalent); highly proficient in the functionality of MS Word, Adobe Acrobat, and PowerPoint.