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Janssen Research & Development, part of the Johnson & Johnson Family of Companies, is recruiting for a Lead Regulatory Scientist . The preferred location is Raritan, New Jersey or Spring House, Pennsylvania. Other locations in the U.S. and Canada may be considered.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to build a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us! We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Janssen Global Regulatory Affairs (GRA) Lead Regulatory Scientist will provide support to the North American Regulatory Leader (NARL) and/or Global Regulatory Leader (GRL) with regulatory activities for compounds in development and/or marketed products in the assigned portfolio within the Oncology therapeutic area.

Key Responsibilities:

• Participate in global and regional regulatory team meetings and provide advice on applicable regulatory requirements and project-specific regulatory issues.

• Build an understanding of the regional regulatory environment (relevant laws, regulations, guidance and competitive landscape) for assigned products.

• Assist in preparation for Health Authority (HA) meetings, act as backup contact with HA as needed.

• Ensure regulatory submissions, communications and responses to HA queries are made in a timely manner and are consistent with the regulatory strategy.

• Work cross-functionally and lead team meetings as appropriate.

• Review development plans, protocols and submission plans, ensuring alignment with regulatory requirements

• Support the development and improvement of processes related to regulatory submissions.

Qualifications

Education:

• Bachelor’s degree in a scientific or equivalent subject area with 6 years of relevant industry experience, or Master’s degree with 4 years of relevant experience, or PharmD/PhD with 2 years of relevant experience.

Required:

• Previous regulated health industry experience.

• Proven understanding of drug development and regulatory processes.

• Knowledge of US guidelines and practices in the regulatory environment.

• Ability to work optimally within a cross-functional team and as an individual contributor.

• Project management, oral & written communication skills, organization and multi-tasking skills.

• Strong time management skills.

• Proven critical thinking and contingency planning skills with respect to organizational objectives.

• Effective critical thinking, including problem solving and goal setting for improved efficiencies.

Preferred:

• Direct experience in regulatory affairs and/or Oncology drug development.

• Regulatory, clinical or R&D experience with products in early and late development stages.

• Experience responding to HA requests, handling HA interactions, and lifecycle management of regulatory applications.

Leadership Capabilities:

• Proactively anticipates issues; exercises judgment in developing new approaches/solutions and solving problems.

• Influences or persuades others within area of immediate responsibility, scope and level to accept new insights, practices and approaches

• May have interaction with internal and external colleagues with coordination between departments.

• May represent J&J or company externally with some degree of supervision.

The anticipated base pay range for this position in US locations is MIN $102,000 to MAX $163,300.
The anticipated base pay range for this position in San Francisco Bay Area, CA is MIN $116,700 to MAX $187,795.

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.

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

Additional information can be found through the link below.

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

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.