Lead Regulatory Scientist - Johnson and Johnson

Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Lead Regulatory Scientist. This position can be located in Spring House, PA; Malvern, PA, Raritan, NJ; or Titusville, NJ. Remote locations within the United States may be considered on a case-by-case basis and if approved by the company.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiovascular and metabolism, and pulmonary hypertension. Please visit http://www.janssenrnd.com for more information.

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. As a Lead Regulatory Scientist, 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. In addition, you will acquire the business savvy to be successful in a complex, fast-paced, and innovative regulatory environment.

Principal 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 be knowledgeable of laws, guidances 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 Johnson & Johnson/Janssen externally with some degree of supervision.

• A minimum of a Bachelor's degree in a scientific or related discipline is required. Advanced degree (Master's, PharmD, PhD) preferred.
• A minimum of 6 years of relevant industry experience with a Bachelor's degree; a minimum of 4 years of relevant industry experience with a Master's degree; or a minimum of 4 years of relevant industry experience with a PharmD or PhD degree is required.
• Previous experience in a health regulated industry is required.
• Understanding of the drug development process is required.
• Understanding of the regulatory submission and approval process and applicable U.S. and European Medicines Agency (EMA) regulatory guidelines is preferred.
• Relevant regulatory affairs experience in the pharmaceutical/biotech industry is preferred.
• Experience responding to Health Authority (HA) requests, managing HA interactions, and life cycle management applications is preferred.
• Diverse therapeutic area experience is preferred.
• Experience managing and effectively prioritizing assignments for multiple projects simultaneously is preferred.
• Experience collaborating with all levels and influencing decision-making within a cross-functional team environment is required.
• Must have excellent communication and interpersonal skills.
• Must proactively anticipate issues and exercise judgment in developing new approaches/solutions to resolve issues.
• Must have strong problem-solving and conflict resolution skills, with the ability to think strategically and contingency plan in order to meet business objectives.
• This position will require up to 10% domestic and international travel.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $119,000 to $191,820.

The anticipated base pay range for this position in all other U.S. locations is $104,000 to $166,750.

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

This job posting is anticipated to close on February 22, 2024. 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.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.