Lead Regulatory Scientist

Job Description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

**Job Function:**

Regulatory Affairs Group

**Job Sub Function:**

Regulatory Affairs

**Job Category:**

Professional

**All Job Posting Locations:**

Raritan, New Jersey, United States of America

**Job Description:**

**About Innovative Medicine**

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 Lead Regulatory Scientist to be located in Raritan, NJ.**

**Purpose:** The Lead Regulatory Scientist provides support for regulatory activities for products in the assigned portfolio, including ensuring that content and intent of regulatory filings support the US/ global regulatory strategy.

**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 work with the North America Regulatory Lead to ensure responses to Regulatory Agency queries are made in a timely manner, and that content is consistent with the regulatory strategy.
* Work cross-functionally and lead team meetings as appropriate
* Review clinical trial plans, protocols and submission plans ensuring alignment with regulatory requirements
* Advise team in required documents and submission strategies
* Support the development and improvement of processes related to regulatory submissions.
* Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints.
* Keep abreast of current and pending approvals in specific therapeutic areas and is knowledgeable of laws, guidances and requirements related to those areas.

**Qualifications / Requirements:**

**Education:**

* Minimum of a Bachelor’s degree in scientific or equivalent discipline is required.

**Skills/Experience:**

* Minimum of 4 years relevant industry experience, depending on educational level achieved
* Previous health regulatory industry experience and understanding of the drug development process is required
* Understanding of regulatory submission and approval process and applicable US regulatory guidelines preferred
* Relevant regulatory affairs experience in pharmaceutical/biotech is desirable.
* Experience responding to Healthy Authority (HA) requests, managing HA interactions and life cycle management of IND/ NDA applications is beneficial
* Skilled at effectively prioritizing assignments for multiple projects simultaneously.
* Experience within a cross-functional team environment as an individual contributor and decision maker within a matrix organization
* Strong interpersonal and communication skills.
* Project management experience and ability to manage multiple priorities is highly beneficial
* Diverse therapeutic area experience beneficial

**LEADERSHIP CAPABILITIES**

* 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
* May interact with internal and external colleagues with coordination between departments.
* May represent J&J or company externally with some degree of supervision.

The expected pay range for this position is $105,000 to $169,050.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Employees are eligible for the following time off benefits:

* Vacation - up to 120 hours per calendar year
* Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
* Holiday pay, including Floating Holidays - up to 13 days per calendar year
* Work, Personal and Family Time - up to 40 hours per calendar year

For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States.

Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

This job posting is anticipated to close on July 14, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

**The anticipated base pay range for this position is :**

$105,000 to $169,050

_Additional Description for Pay Transparency:_

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Employees are eligible for the following time off benefits: Vacation – up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.