Sr. Regulatory Affairs Professional, Global TA

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.

You will be responsible for:

• 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

Qualifications / Requirements:
Education: Bachelor’s degree in a scientific or equivalent discipline + 6 years experience in academia or industry OR Pharm D/PhD + 2 years experience OR Masters +3 years of experience is required.

Experience and Skills Required: Understanding of the drug development process.

Preferred:

• 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

#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking

The anticipated base pay range for this position is :

$109,000.00 - $174,800.00

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