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Manager Global CMC Regulatory Affairs - 2406185933W

Description

Johnson & Johnson Innovative Medicine is recruiting for a Manager, CMC Regulatory Affairs to be located in Raritan, NJ; Titusville, NJ; or Beerse, Belgium.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/ .

Key Responsibilities

Regulatory Strategy

• Develops and realize global regulatory strategies for development compounds and marketed products according to scientific and risk-based principles.

• Participates as regulatory lead on CMC/VCM teams and represents CMC RA by providing regulatory expertise to these teams and global regulatory teams.

• Ensures that CMC regulatory strategy is aligned with strategies of global regulatory Affairs, therapeutic areas and regional functions.

• Assures connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory affairs

• Develops and realizes contingency plans for issues that affect registration, regulatory compliance and lifecycle management of the product

• Refines regulatory strategies as new data become available

• Provides accurate regulatory assessments for CMC change controls

Submissions

• Leads the preparation of dossiers for submission to Health Authorities

• Coordinates, compiles and follows up on the CMC dossiers

• Reviews CMC dossiers for global submissions throughout the product lifecycle

Health Authority Interactions

• communicates effectively and thoughtfully with Health Authorities

• submits CMC Health Authority responses according the defined the strategy

• Provides support during Health Authority inspections

Others

• drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectation

• Participates in initiatives within CMC-RA or Global Regulatory Affairs

• Conducts due diligence/licensing evaluations where needed

Qualifications

• Bachelors in Science (engineering, biological, pharmaceutical or chemical) with minimal 6 years of proven experience or equivalent experience is required.

• Solid understanding and experience with global Health Authorities regulations and guidances is required.

• Effective verbal and written communication as well as organizing skills and attention to detail are required.

• Communicating effectively regulatory requirements and defend strategies to the project teams is required.

• Demonstrating model behavior, understanding the business priorities and inspiring others to aim for optimal results is required.

• Prior experience in drug development, analytical development or pharmaceutical manufacturing is an asset.

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 all other US locations is $113,00 - $195,500

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

Primary Location NA-US-New Jersey-Raritan

Other Locations Europe/Middle East/Africa-Belgium-Antwerp-Beerse, NA-US-New Jersey-Titusville

Organization Janssen Research & Development, LLC (6084)

Job Function Regulatory Affairs

Req ID: 2406185933W