Senior Associate – Regulatory Affairs

Senior Associate – Regulatory Affairs

Requirements

• Bachelor’s degree in a relevant field.
• Two or more years prior experience at a drug or biologics company.
• Some familiarity with regulatory requirements for development of drug and biological products, including FDA regulations and guidance, and ICH guidelines.
• Willing to advance knowledge of regulatory practice through classes, certifications, and webinars.
• Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in an electronic document management system.

Responsibilities

• Support and/or represent Regulatory Affairs at study team meetings and collaborate with multidisciplinary teams to identify submission requirements, coordinate the content development process (planning, creation, review, and approval) of selected regulatory documentation for inclusion in submissions to global health authorities.
• Maintain current and complete documentation for maintaining global health authority query (HAQ) tracker and archiving regulatory correspondences and commitment tracking.
• Compile regulatory submissions that meet ICH or FDA requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures.
• Prepare and manage routine submissions and related activities.
• Review site activation documents and provide regulatory approval to activate sites.
• Assist in the development and implementation of SOPs and systems to track and manage product-associated events.
• Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assist in assessment of regulatory implications for development and approval. Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
• Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects.
• Work with manager on acquisition and development of required regulatory skills and knowledge.
• Function as the Subject Matter Expert (SME) of Clinical Trial Regulations (CTR) in the EU.
• Function as the Subject Matter Expert on the internal cross functional process for collecting and submitting investigator documents and safety submissions to INDs. This includes developing and providing training within teams.

Preferred Qualifications

• Experience in oncology drug development.
• Experience with supporting the preparation and submission of large complex regulatory submissions.