Description

Janssen Research & Development, LLC. is recruiting for a Director, Global Regulatory Affairs – CMC (Biologics/Cell and Gene therapy) . This position can be located in the United States (Malvern/Chesterbrook, PA; Spring House, PA; Raritan, NJ; Titusville, NJ; Horsham, PA) or Europe (Leiden, Netherlands; Allschwil, Switzerland or Beerse, Belgium).

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 and Development, LLC. is part of the Janssen Pharmaceutical Companies.

The Director, Global Regulatory Affairs – CMC (Biologics/Cell and Gene therapy) is responsible for developing global CMC regulatory strategies and content plans according to scientific/risk-based regulatory strategies.

Principal responsibilities:

• Works closely with the senior leadership team in developing and proposing direction in key areas to ensure a high performing organization and consistent application of practices, policies, systems and programs.
• Planning, organizing, and directing resources and activities within CMC RA related to biologics and cell and gene therapy. Partnering with the business support groups to drive the execution of identified projects and workstreams.
• Coordination of selected initiatives within CMC RA, especially in cell and gene therapy, in a working collaboration with JSC and R&D. Conducts or mentors’ staff on projects and on alignment with due diligence program on critical CMC information impacting regulations with in-licensed projects
• Represent regulatory CMC on gene therapy pipeline projects that may span multiple products and future development actions. Assures that CMC Reg requirements and expectations are met (e.g., facility startups, selection of material suppliers, platform changes, etc.)
• Supports early development projects to assure development plans will meet regulatory expectations in the target countries for clinical programs and future development.
• Supervise and provide leadership and oversight for CMC RA staff that develop and execute global CMC regulatory strategy for one or more product(s).
• Assures that appropriate objectives and metrics are established, monitored and met, including removing barriers.
• Responsible for training, coaching and development of junior staff members with a focus on mentoring CMC RA staff transitioning across product class (e.g., chemical to biologic, biologic to gene therapy, pre to post approval and vice versa). Coaches technical writing and reviewing skills for the staff of the department. May act as a mentor for rotational assignments with CMC RA.
• Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements, and expectations. Communicates critical issues to Senior Management.
• Represents CMC RA on Cross Functional Governance Committees
• Creates engagement and a culture of collaboration flexibility, and competitiveness by increasing business and scientific acumen, industry knowledge and skills
• Enables a culture of performance driving a more flexible organization using levels as process improvement and innovation supported by the business support group

Qualifications

• A minimum of a Bachelors in biological, pharmaceutical, chemical, or engineering sciences with a minimum of 12+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent is required.
• Successful experience in leading a diverse community of professionals in a global and matrix environment is required. (Seasoned leader, decision maker and constructive challenger)
• Broad knowledge of the biopharmaceutical industry is required; including in-depth operational knowledge of life cycle management of the processes and functions involved in biologics and cell & gene therapy development and commercialization.
• Proven track record and/or deep understanding of the application of global regulatory strategies to the development and implementation of successful CMC regulatory lifecycle strategies across biologic and gene therapy programs is required.
• Strong attention to detail with high-level verbal and written communication skills is required.
• Makes decisions based on facts and sound scientific principles is required.
• Ability to interact with all levels in the organization is required.
• Communicates cross-functionally and cross-company; presents and defends CMC management-approved regulatory strategy to project teams; recognizes and accounts for global regulatory impact is required.
• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results is required.
• Experience leading health authority interactions is required.
• Strong knowledge of global regulatory laws, regulations, guidance, and submission routes pertaining to drugs from early development to commercial maturity is required.
• Detailed understanding of competitors in the area and what they are doing in early/late development for biologics and cell and gene therapy is preferred.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

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 $175,375 to $302,852.

The anticipated base pay range for this position in all other US locations is $152,500 - $263,350.

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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits