Senior Associate, Regulatory Affairs

Hybrid - 3 days onsite

6 month initial contract (likely exetnsion and convert to FTE)

Responsibilities :

• Represent Regulatory Affairs on project teams and closely collaborate with multidisciplinary teams to identify submission requirements, coordinate the content and development process (planning, creation, review, and approval) of selected regulatory documentation for inclusion in submissions to global health authorities.
• 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. Define and manage detailed timelines to ensure timely delivery of high-quality, compliant, accurate and complete regulatory submissions.
• 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.

Required Skills, Experience and Education:

• Bachelor’s degree in a relevant field.
• Two or more years prior experience in a Regulatory Affairs department 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 my knowledge of regulatory practice through classes, certifications, webinars.
• Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in an electronic document management system. Preferred

Skills :

• Experience in oncology drug development
• Experience with supporting the preparation and submission of large complex regulatory submissions, including NDA’s
• Excellent written and verbal communication skills