Lead Regulatory Scientist, Global Regulatory Affairs (Oncology)

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Lead Regulatory Scientist, Global Regulatory Affairs (Oncology) to be located in Raritan, NJ or Spring House, PA.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose: This position will support the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the Oncology therapeutic area.

You will be responsible for:

• Provide support to the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) for regulatory activities for products in the assigned portfolio, including assuring that content and intent of regulatory filings support the global regulatory strategy
• Participate in global regulatory team meetings as appropriate
• Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
• Develop an understanding of the North American regulatory environment, competitor intelligence and therapeutic area
• Act as back-up for contact with Regulatory Agencies as needed
• Draft documentation for Regulatory Agency communication
• Assist in the preparation of meetings with Regulatory Agencies
• Collaborate with Local Operating Companies (LOCs), and ensure responses to queries are made in a timely manner, and that content is consistent with the regulatory strategy
• Assist in the development and improvement of processes related to regulatory submissions
• Review clinical trial plans and protocols and ensure alignment with regulatory requirements
• Provide regulatory support throughout registration process and life-cycle management
• Advise team regarding required documents and submission strategies (in collaboration with LOCs as appropriate)
• Assist with timely availability of submission documents and ensure that all document components are in place on time
• Draft and review some document content (depending on level of regulatory knowledge/expertise)
• Prepare, hold and lead cross-functional team meetings as appropriate
• Understand submission details and collaborate closely with Submission Management
• Review and approve submission plans
• Review of submission documents to ensure compliance with regulatory requirements
• Assist with submission and acceptance of the submission package
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support and product complaints
• Serve as the Regulatory representative on specific multi-discipline teams
• Stay on top of current and pending approvals in specific therapeutic areas and knowledgeable of laws, guidances and requirements related to those areas.

Qualifications / Requirements:

Education:

• Minimum of a Bachelor's degree is required.

Skills/Experience:

Required:

• Minimum of 6 years of previous health regulated industry experience or relevant academic experience
• Understandi