Lead Regulatory Scientist - 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:
Horsham, Pennsylvania, United States of America, Malvern, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, 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

Johnson & Johnson Innovative Medicine R&D is recruiting for a Lead Regulatory Scientist - Oncology.

 This position can be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; or Malvern, PA. 

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.

Principal Responsibilities:


* Participate in global regulatory team meetings and provide advice the applicable regulatory requirements, project-specific regulatory issues.


* Build an understanding of the regional regulatory environment (relevant laws, regulations, guidance and competitive landscape) for assigned products.


* Assist in strategy development by researching regulatory and medical information in preparing submissions to North American Health Authorities (HAs).


* Assist in the preparation of HA meetings and act as back-up for contact with HA as needed.


* Ensure responses to HA queries are made in a timely manner, and that content is consistent with the regulatory strategy.


* Provide regulatory support throughout registration process and life-cycle management.


* Work cross-functionally and lead team meetings as appropriate.


* Review development plans, protocols and submission plans, ensuring alignment with regulatory requirements.


* Support the development and improvement of processes related to regulatory submissions.


* Stay on top of current and pending approvals in spe...