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Lead Regulatory Scientist (1 of 3).

Employer
Johnson & Johnson
Location
Titusville, New Jersey, US
Salary
Competitive
Closing date
Jan 15, 2022

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Sector
Academic / Research
Field
Conservation science
Discipline
Other
Salary Type
Salary
Employment Type
Full time
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Janssen Global Regulatory Affairs (GRA) is currently recruiting for a Lead Regulatory Scientist. The preferred position location is Raritan, NJ however other acceptable locations include Titusville, NJ; Spring House, PA; La Jolla, CA; Cambridge, MA; or Toronto, Canada.

Caring for the world one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science, bringing innovative ideas, products, and services to advance the health and well-being of people. And, at Janssen Pharmaceutical Companies of Johnson & Johnson, we use heart, science and ingenuity to create transformational medicines to improve the health of humanity. Every day, we work to advance scientific research and commercial innovation, to deliver solutions that provide value to patients, physicians and healthcare systems around the world. Growing on a diverse company culture, we celebrate the uniqueness of our employees and are committed to inclusion. Proud to be an equal opportunity employer. And our culture is interconnected by the shared values of Our Credo. It's a culture that celebrates diversity and diverse perspectives. It helps employees achieve an effective mix between work and home life and supports their efforts to have a positive impact on their communities.

As a Lead Regulatory Scientist, you will support drug development programs as well as marketed products across multiple therapeutic areas across Janssen Research and Development. 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 Janssen's portfolio via a flexible rotational program geared towards addressing business needs and individual career-development goals.

Additionally, you will have the opportunity to develop leadership skills by participating in individual/small group trainings and coaching experiences and be exposed to GRA organizational initiatives. Furthermore, the candidate will acquire the necessary skills and business savvy to be successful in a complex, fast-paced, and innovative regulatory environment.

Essential Functions
  • Lead and/or contribute to the planning, preparation (including authoring of Regulatory documents e.g. Cover Letters, Health Authority Forms, etc.) and delivery of simple and more complex submissions throughout the product's life cycle from either a global and/or regional perspective.
  • Partnering with regulatory colleagues to understand the competitive landscape, e.g., views of health authorities, regulatory precedents, labeling differences and therapeutic area specific issues.
  • Project manage submission delivery of all application types per market and /or region.
  • Serve as the Regulatory representative on specific multi-discipline teams, including coordinating and leading meetings.
  • Assist in strategy development by researching regulatory and medical information in preparing submissions to regional HAs.
  • Understand the regulatory framework, including regional trends, for various types of applications and procedures, and maintain solid understanding of local regulations and submission requirements for lifecycle submissions.
  • Review and interpret related product approval information and current HA guidances and Advisory Committee meetings
  • Maintain up-to-date knowledge of regulations and industry environment and provide guidance on potential trends;
  • Coordinate, contribute and review the content of responses to queries from HAs for respective/regions and countries ensuring they are of high quality and submitted in accordance with timelines

Education

Qualifications
  • Minimum of a Bachelor's degree in a scientific or equivalent discipline
  • Bachelor's degree and 6+ yrs overall experience OR;
  • Master's degree plus 4+ yrs overall relevant experience OR;
  • PharmD/PhD plus 2+ years of overall experience

Required

Experience and Skills:
  • Understanding of the drug development process is required.
  • Demonstrated experience in critically reviewing and compiling scientific documents is required.

Preferred
  • Knowledge of the regulatory submission and approval process is preferred.
  • Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is preferred.
  • Knowledge of the regulatory environment, US guidelines and practices is preferred.
  • Regulatory, Clinical or R&D experience with products in early and late development stages is preferred.
  • Diverse therapeutic area and/or functional area experience is beneficial.

Leadership Capabilities
  • Strong collaboration skills, including effective communication and conflict resolution skills.
  • Strong Leadership capabilities and ability to work successfully in a matrixed environment.
  • Exercises strong organizational and time management skills
  • Demonstrated ability of strategic thinking and contingency planning with respect corporate objectives.
  • Effective critical thinking including problem solving and goal setting for improved efficiencies.

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.

Primary Location

United States-New Jersey-Raritan-920 US Highway 202

Other Locations

North America-Canada-Ontario-Toronto, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, North America-United States-California-La Jolla, United States-Massachusetts-Cambridge

Organization

Janssen Research & Development, LLC (6084)

Job Function

Regulatory Affairs

Requisition ID

2105991331W
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