Manager Global CMC Regulatory Affairs

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