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, Titusville, New Jersey, United States of America
Job Description:About Innovative MedicineOur 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 a
Global Regulatory Affairs Scholar, located in Spring House, PA, Raritan or Titusville, NJ. This role is eligible for one-way US relocation assistance.
Global Regulatory Affairs Scholar Program Overview:The Global Regulatory Affairs (GRA) Scholar Program at Johnson & Johnson is a two-year experiential fellowship that provides recent university graduates with advanced, hands-on professional development at one of the world's leading health care companies. Under the mentorship of J&J regulatory professionals, GRA Scholars complete multiple rotations across different disease-therapeutic areas, and related regulatory functions, such as Product Labeling, Policy and Intelligence, and Chemistry, Manufacturing and Controls.
You will be responsible for:- Develop a broad understanding of the global drug development lifecycle and related strategies for engaging health authorities.
- Learn the laws, guidance's, and regulatory requirements for drugs and combination products while staying aligned with the organization's goals.
- Tackle real-world projects that build your leadership presence, strengthen your ability to influence stakeholders, and enhance your collaboration, problem-solving, and presentation skills.
- Grow your professional network and cross-functional exposure while working with different teams.
- Participate in internal and external meetings to support your role's responsibilities.
- Own a complex capstone project and present results to GRA senior leaders and other internal partners.
Qualifications / Requirements:Education: Earned a bachelor's degree (B.S. or B.A.) from a 4-year university program. Earned or is currently pursuing an advanced degree (Master's level) in scientific, technology or engineering related field from an accredited academic institution with a planned graduation by May 2027. Examples include, biomedical engineering, data analytics/applied statistics, quantitative modeling in biology, pharmacy or other healthcare science.
This position is strictly suited for candidates with early professional experience who are looking to develop their careers in regulatory affairs.Experience and Skills Required: Strong academic track record is required.
Preferred:- Some fundamental understanding of pharmaceutical drug development. Knowledge of current Food and Drug Administration (FDA) regulations, guidelines, and submission requirements is desired.
- Proven leadership capabilities in an organizational setting (campus/community activities) is desired.
- Able to work independently, as well as, be part of a group, with curiosity and flexibility.
- Be self-motivated, possess a "can do" approach, and courage to speak your voice and suggest innovative ideas.
- Be a creative problem solver, with an interest in exploring the international context of healthcare systems and technology contexts.
#LI-Hybrid
Ineligibility for severance.
Required Skills:Preferred Skills:Analytical Reasoning, Business Behavior, Business Writing, Collaboration, Communication, Confidentiality, Data Reporting, Data Savvy, Detail-Oriented, Execution Focus, Legal Support, Medicines and Device Development and Regulation, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments
The anticipated base pay range for this position is :$76,000.00 - $121,900.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
