Associate Manager, Regulatory Affairs Strategy – Oncology

Jobtailor; New Jersey; On-site; USD 90,000 - 130,000; Full time

Job summary

Jobtailor is seeking a Regulatory Affairs professional to coordinate global regulatory submissions in oncology, including INDs/CTAs, Orphan drug apps, and annual reports. This role emphasizes collaboration with cross-functional teams and CROs to drive clinical development programs.

The ideal candidate has 2–3 years of pharmaceutical regulatory experience, a Bachelor's degree (advanced degree preferred), and strong knowledge of US FDA and international guidance.

Qualifications

• Minimum Bachelor's Degree; advanced degree preferred.
• 2–3 years of regulatory affairs experience; oncology preferred.
• Knowledge of US FDA and international regulatory guidance, regulations and drug development processes.
• Experience coordinating with CROs for ex-US/ex-EU CTAs.
• Strong written and verbal English communication; high attention to detail.

Responsibilities

• Coordinate preparation, submission, management and maintenance of global regulatory submissions in oncology (INDs/CTAs, amendments, Orphan drug apps, annual reports, Investigator's Brochure).
• Assist in Agency meeting coordination and briefing document preparation.
• Manage queries and commitments with regulatory agencies; provide written responses with SMEs.
• Represent study-level regulatory activities and participate in cross-functional projects.
• Research regulatory strategy for assigned clinical development programs.
• Maintain up-to-date regulatory knowledge and communicate changes as needed.
• Exercise discretion and independent judgment in duties.

Skills

Regulatory Submissions Management

Oncology Therapeutic Area Knowledge

US FDA Regulations

Clinical Development Strategy

Interpersonal Communication

Education

Bachelor's Degree

Advanced Degree Preferred

Job description

• 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

Requirements

• 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

Core Competencies

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.

Highest-signal resume keywords

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

ATS Optimization Keywords

Hard Skills

• 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

Soft Skills

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

Certifications & Qualifications

• Bachelor's Degree
• Advanced Degree Preferred

Industry Keywords

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