Janssen Research & Development, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, Regulatory Scientist. This position can be located at a Johnson & Johnson site in the United States or Canada. Remote locations within the United States and Canada 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.

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

Principal Responsibilities:

• Lead and/or contribute to the planning, preparation, and delivery of simple Health Authority (HA) submissions (e.g., information amendments, safety reports, responses to HA inquiries), and complex submissions (e.g., IND, NDA/BLA applications, meeting packages) throughout the product’s life cycle, for the North America region.
• Partner with regulatory colleagues to understand the competitive landscape, e.g., views of health authorities, regulatory precedent, labeling differences, and oncology-specific issues.
• 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 North American Health Authorities (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 guidance and Advisory Committee meetings.
• Maintain up-to-date knowledge of regulations and industry environment and provide guidance on potential trends.
• Coordinate, contribute to, and review the content of responses to queries from North American HAs to ensure high quality and timely responses.
• Provide input to Standard Operating Procedure (SOP) documents to ensure accuracy and compliance. May assist in the development and improvement of regulatory processes.

Qualifications

• A minimum of a Bachelor’s degree in a scientific or related discipline is required. Advanced degree (Master’s, PharmD, Ph.D.) preferred.
• A minimum of 6 years of industry experience with a Bachelor’s degree; a minimum of 5 years of industry experience with a Master’s degree; or a minimum of 4 years of industry experience with a PharmD or Ph.D. degree is required.
• Relevant Regulatory Affairs experience in the pharmaceutical/biotech, medical device or consumer over-the-counter (OTC) industry is required.
• Understanding of U.S. Food and Drug Administration (FDA) and International Council for Harmonization (ICH) Technical Requirements for Pharmaceuticals for Human Use is required.
• Understanding of Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.
• Strong knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required.
• Experience with FDA regulatory submissions required.
• Experience responding to FDA requests and managing FDA interactions required.
• Experience managing and prioritizing multiple projects simultaneously is required.
• Knowledge of FDA/Health Canada organizational structure and processes for reviewing submissions preferred.
• Experience in the Oncology Therapeutic Area experience in preferred.
• Experience with companion diagnostics, combination products and/or biomarker development is preferred.
• Experience with ex-US Regulatory Affairs preferred.
• Must have excellent communication skills.
• Must have strong problem-solving and conflict resolution skills, with the ability to think strategically and contingency plan in order to meet business objectives.
• Must have strong leadership capabilities and ability to work successfully in a matrixed environment.
• The ability to collaborate with all levels and influence decision-making within a cross-functional organization is required.
• This position will require minimal travel.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $128,000 to $220,915.

The anticipated base pay range for this position in all other US locations is $111,000 to $192,050.

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.

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.