Associate Manager, Regulatory Affairs Strategy – Oncology

• Coordinating the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development in oncology therapeutic area, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
• Assisting in coordination and preparation for Agency meetings and associated briefing document preparation
• Managing and tracking queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
• Providing representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
• Performing research to support the development of regulatory strategy for the assigned clinical development program
• Maintaining knowledge of regulatory requirements up to current date, comments on draft regulatory guidance, and communicates changes in regulatory information as needed
• Exercising discretion and independent judgment in the performance of the duties described above

• Minimum Bachelors Degree (Advanced degree strongly preferred)
• 2-3 years of pharmaceutical industry experience in regulatory affairs; experience in oncology preferred
• Knowledgeable of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices
• Experience interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
• High attention to detail; ability to organize and prioritize assigned projects according to corporate goals
• Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization
• Proficient in written, oral, and interpersonal communications in English

Demonstrates expertise in regulatory submissions and compliance within the oncology therapeutic area, with a strong understanding of US FDA and international regulations. Capable of managing cross-functional collaboration and maintaining up-to-date knowledge of regulatory requirements.

• Regulatory Submissions Management
• Oncology Therapeutic Area Knowledge
• US FDA Regulations
• Clinical Development Strategy
• Interpersonal Communication

• Regulatory Submissions
• INDs/CTAs
• Orphan Drug Applications
• Annual Reports
• Investigator’s Brochure
• Regulatory Strategy Development
• CRO Interaction
• Drug Development Process
• Regulatory Guidance Knowledge
• Project Management

• Attention to Detail
• Organizational Skills
• Collaboration
• Prioritization
• Independent Judgment

• Bachelor's Degree
• Advanced Degree Preferred

• Pharmaceutical Industry
• Regulatory Affairs
• Clinical Trials
• Ex-US/Ex-EU CTAs
• Cross-Functional Team Projects