What are the responsibilities and job description for the Product Development Manager position at Johnson & Johnson?
This is an exciting opportunity to join our team as a Medical Director, leading our North American Regional Lead team. As a key member of our regulatory affairs team, you will be responsible for developing and implementing global regulatory strategies, leading cross-functional teams, and interacting with Health Authorities.
Key Responsibilities:
- Develop and implement global regulatory strategies
- Lead cross-functional teams, including Compound Development Team (CDT)
- Interact with Health Authorities, leading and participating in meetings
You will have the opportunity to work on a range of novel product solutions to deliver solutions to treat cancers directly into the tumor. You will establish North American content requirements and timing for global dossier plans, serve as the primary point of contact for US FDA, and lead the regulatory response team for FDA and Health Canada questions.
You will also contribute to the development of the USPI, lead the development of NA labeling negotiation strategies, and develop supporting documentation for labeling. In addition, you will provide integrated global labeling and filing strategies for assigned projects.
