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Associate Director, Regional Regulatory Leader

Auris Health

Auris Health

Legal
United States
Posted on Wednesday, September 13, 2023
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Description

Janssen Research & Development, L.L.C., a division of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director, Regional Regulatory Leader, supporting the Interventional Oncology R&D unit. The position will focus on a range of novel product solutions to deliver solutions to treat cancers directly into the tumor. The position can be located in Raritan, NJ; Spring House, PA; or within the United States or Canada (Eastern Coast preferred).  Preferred location: Any Johnson & Johnson campus North America (other locations could be considered for the right candidate).

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create 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.

Key Responsibilities:

  • Responsible for developing and implementing US and/or regional strategy for assigned programs.
  • Key contributor to the development and implementation of US and/or other regional regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approvals.
  • In collaboration with the global regulatory team, develop global submission plans and Health Authority interaction plans.
  • Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
  • Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
  • Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).
  • Provide strategic regulatory input to key development documents, including clinical protocols, clinical and nonclinical reports and summary documents.
  • Understand the regulatory framework, including regional trends, for various types of applications and procedures across all regions.
  • Collaborate with cross-functional submission delivery teams.
  • Participate and coordinate Health Authority interactions by leading regulatory team members and cross-functional team members through preparation of materials and meeting preparation.
  • Serve as primary point-of-contact to Health Authority for assigned region(s).
  • This role will include an opportunity to flex across different product types (pharma, devices, combo products).

Qualifications

  • Minimum of a Bachelor’s degree in scientific or equivalent discipline is required.
  • Bachelor’s degree plus 8+ years relevant experience OR Master’s degree/ PharmD/PhD  and a minimum of 6 years of health regulated industry experience is required.
  • Relevant regulatory experience and understanding of clinical drug development, working with US FDA and global regulatory health authorities is required.
  • Experience responding to FDA and other Health Authorities (HA) requests and managing Health Authorities interactions is required.
  • Understanding of FDA and ICH Regulatory requirements and guidelines specific to the areas of clinical research, product development, and labeling is required.
  • Knowledge of multiple global health authorities ‘regulations and processes’ would be ideal.
  • Experience in lifecycle management of IND/NDA/CTA/MAA and other regulatory submissions is required.
  • Demonstrated experience in critically reviewing and compiling regulatory documents is required.
  • Proven ability to work successfully within a reciprocal team environment as an individual contributor and decision maker within a cross-functional organization is required.
  • The ability to effectively prioritize assignments for multiple products and projects is required.
  • Therapeutic area experience in oncology is highly desirable.
  • Experience CDx, combination products and/or biomarker development, or medical device is beneficial.
  • Intellectual curiosity and an ability/flexibility in learning new things and working in novel areas with limited regulatory precedence.
  • 10% domestic travel and potential international travel will be required for this position.

LEADERSHIP CAPABILITIES

  • Leadership capabilities and ability to work successfully in a matrixed environment.
  • Demonstrated ability to think strategically and contingency plan in order to meet business objectives.
  • Strong collaboration skills, including effective communication and conflict resolution skills.
  • Strong interpersonal, organizational, and time management.
  • Exercises independent judgment and execution in anticipating, evaluating and resolving complex functional and/or complex organizational issues with novel solutions.
  • Effective critical thinking including problem solving and goal setting for improved efficiencies.
  • May represent J&J or company externally with limited supervision.  
  • May cultivate and leverage strategic networks and partnerships.

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.

The anticipated base pay range for this position in the San Francisco Bay Area, CA is $166,000 - $267,145.

The anticipated base pay range for this position in all other US locations is $135,000 - $232,300.

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

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.