Sr. Regulatory Affairs Professional

Johnson & Johnson Innovative Medicine•Hopewell Township, NJ

3d•Hybrid

About The Position

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 a Sr. Regulatory Affairs Professional, located in Spring House, PA, Raritan or Titusville, NJ. This position is strictly suited for candidates with early professional experience who are looking to develop their careers in regulatory affairs. Global Regulatory Affairs (GRA) is looking for a high energy, inventive, self-starter who is passionate about advancing their career in healthcare. GRA is a key strategic partner supporting global R&D initiatives at Johnson & Johnson Innovative Medicine. As a Sr. Regulatory Affairs Professional you will support drug development programs as well as marketed products across multiple therapeutic areas. You will gain broad and diverse regulatory experience supporting compounds in early to late drug development as well as life-cycle activities for approved products in our portfolio via a flexible rotational model geared towards addressing business needs and individual career-development goals. Through hands-on, real-world experiences, you will work on projects that improve your leadership, problem solving, and creative thinking skills. Furthermore, you will acquire the business savvy to be successful in a complex, fast-paced, and innovative regulatory environment.

Requirements

Pharm D/PhD with 2-5 years’ experience OR Masters with 3-5 years of experience is required.
This position is strictly suited for candidates with early professional experience who are looking to develop their careers in regulatory affairs.
Understanding of the drug development process.
Analytical Reasoning
Business Writing
Coaching
Collaborating
Communication
Legal Support
Problem Solving
Product Licensing
Public Policies
Regulatory Affairs Management
Regulatory Compliance
Regulatory Development
Regulatory Environment
Regulatory Reporting
Risk Assessments
Strategic Thinking

Nice To Haves

Previous experience in a health regulated industry
Understanding of regulatory submission and approval process and applicable US and EMA regulatory guidelines
Relevant regulatory affairs experience in pharmaceutical/biotech
Experience responding to HA requests, managing HA interactions, and life cycle management applications
Diverse therapeutic area experience
Experience within a cross-functional team environment as an individual contributor and decision maker
Proactively anticipates issues; exercises judgment in developing new approaches/solutions and resolving issues
Influences or persuades others within area of immediate responsibility, scope, and level to accept new ideas, practices and approaches
Skilled at project managing and effectively prioritizing assignments for multiple projects simultaneously
Strong interpersonal and communication skills

Responsibilities

Participate in global and regional regulatory team meetings and advise the regulatory team on applicable regulatory requirements, project-specific regulatory issues as assigned
Develop an understanding of the regional regulatory environment, competitor intelligence, and therapeutic area
Assist in the preparation of meetings and act as backup for contact with Regulatory Agencies as needed
Ensure responses to Regulatory Agency queries are made in a timely manner, and that content is consistent with the regulatory strategy
Work cross-functionally, interact with internal and external colleagues with coordination between departments, and lead team meetings as appropriate
Advise team in required documents and submission strategies
Review clinical trial plans, protocols and submission plans ensuring alignment with regulatory requirements
Support the development and improvement of processes related to regulatory submissions
Provide regulatory input for and follow-up to inspections, audits, litigation support, and product complaints
Stay on top of current and pending approvals in assigned therapeutic areas and is knowledgeable of laws, guidelines and requirements related to those areas
May interact with Health Authorities (HA) regarding program-specific issues and serve as secondary HA point-of-contact to represent J&J/Janssen externally with some degree of supervision

Benefits

medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time - 40 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
Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave – 10 days
Volunteer Leave – 4 days
Military Spouse Time-Off – 80 hours