Associate Director, Regulatory Affairs (Labeling) - FSP
Thermo Fisher ScientificSalary not specified
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Senior Manager, Global Labeling Product Leader at Johnson & Johnson
Raritan, New Jersey, United States
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Healthcare, MedTechIndustries
Requirements
- Minimum of a Bachelor’s degree in a scientific discipline (advanced degree such as Master’s, PhD, or PharmD preferred)
- Minimum of 8 years of professional experience
Responsibilities
- Lead the development, revision, review, agreement, and maintenance of primary labeling (Company Core Data Sheet (CCDS), United States Package Insert (USPI) and associated patient labeling, European Union Product Information (EUPI), and derived documents (labeling text for EU, US)) for assigned compounds
- Make recommendations and provide advice and guidance about labeling content, processes, timelines, and scientific integrity
- Coordinate the resolution of any labeling issues with potential impact on the primary or derived labeling, or the supporting documentation
- Ensure high quality and compliant labeling documents (may collaborate with external partners)
- Contribute to and implement the global labeling strategy, including demonstrating an understanding of competitors in the therapeutic area and their development plans and status, and knowledge of labeling aspects for the development of labeling and target labeling
- Contribute to the continuous improvement of the end-to-end labeling process
- Develop methods for planning, directing, coordinating, and controlling the regulatory affairs activities related to new and modified products worldwide in compliance with corporate policies and strategies
- Ensure compliance with regulatory agency regulations and interpretations, accounting for new and changing government regulations
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
Is this role remote or hybrid, and where are the locations?
This is a hybrid role located in Raritan, NJ; Titusville, NJ; or Horsham, PA.
What are the main responsibilities of the Senior Manager, Global Labeling Product Leader?
The role involves leading the development, revision, review, agreement, and maintenance of primary labeling such as Company Core Data Sheet (CCDS), United States Package Insert (USPI), and associated patient labeling, while ensuring compliance with regulations worldwide.
What salary or compensation is offered for this position?
This information is not specified in the job description.
What is the company culture like at Johnson & Johnson Innovative Medicine?
The culture emphasizes patient-inspired innovation, developing treatments and cures, and championing patients while working on teams that advance science-based healthcare solutions.
What makes a strong candidate for this Senior Manager role?
A strong candidate is a leading expert individual contributor viewed as a valuable resource by peers, with expertise in planning, directing, coordinating, and controlling global regulatory affairs for new and modified products in compliance with regulations.
Johnson & Johnson
Healthcare products in pharmaceuticals and devices.
About Johnson & Johnson
Johnson & Johnson operates in the healthcare sector with three main areas: pharmaceuticals, medical devices, and consumer health products. In the pharmaceuticals segment, the company develops prescription drugs for various medical conditions such as cancer and infectious diseases. The medical devices segment provides products used in surgeries and other medical procedures, while the consumer health segment offers over-the-counter products, including baby care and personal health items. Johnson & Johnson generates revenue through direct sales and partnerships, and it invests significantly in research and development to create new products that meet the needs of consumers and healthcare providers. The company stands out from competitors by emphasizing diversity, equity, and inclusion in its workplace, fostering an environment where employees can share their perspectives. Its goal is to improve patient outcomes and enhance the overall health and well-being of individuals globally.
New Brunswick, New JerseyHeadquarters
1886Year Founded
IPOCompany Stage
HealthcareIndustries
10,001+Employees