Director, Global Regulatory Affairs – CMC

Janssen Research & Development, LLC. is recruiting for a Director, Global Regulatory Affairs – CMC. 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 Global CMC Regulatory Affairs Director is responsible for developing global CMC regulatory strategies and content plans according to scientific/risk-based regulatory strategies.

Principal responsibilities:

Regulatory Strategy

• Develop and execute global CMC regulatory strategy for one or more product(s).
• Refine regulatory strategy as new data become available and re-assess as necessary.
• CMC Regulatory Lead on CMC Teams.
• Represent CMC Regulatory viewpoint and expertise on the CMC/VST Team, Global Regulatory Team, including regulatory risk assessments and mitigations associated with proposed strategies.
• Develop and update contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product.
• Confirm CMC strategy is in alignment with Therapeutic Area, regional strategies, commercial strategy, and Quality Target Product Profile.
• Develop and get buy-in on regulatory CMC strategy for Health Authority responses as needed.

Submissions

• Work with the CMC team to develop CMC content and submission plans; able to prioritize based on business impact.
• Prepare regulatory (CMC) sections of development/project plans and provide strategy as issues arise to gain rapid approval with reasonable risk.
• Provide input to and be accountable for the preparation of dossiers for submission to Health Authorities (NDA/BLA/MAA/IRD/IND/CTA and post approval variations).
• Work with the GRT to develop global marketing approval submission plan and timing, complying with local regulatory requirements and commitments.

Health Authority Interactions

• In collaboration with Regional and/or local Regulatory Leader, as applicable:
  • Determine timing and strategy for HA meetings.
  • Prepare company staff for interactions.
  • Lead meetings with Health Authorities.
  • Ability to negotiate with HA personnel.
• Develop strategy for providing responses to HA questions (ensure alignment with global strategy).
• Effectively and tactfully communicate with HA; maintain good rapport and credibility with HA.
• Provide CMC Regulatory support health authority inspections.

Regulatory Input into Other Functions

• Conduct regulatory assessments of CMC change controls.
• Work with the GRT to provide CMC input to global regulatory strategy and submission plans.
• Provide input to Pharmaceutical Development, manufacturing site(s), and commercial packaging selection as decisions can have an impact on the filing strategy.
• Work with GRT to direct, manage and resolve any issues.
• Conduct due diligence assessment on behalf of CMC RA based on the Due Diligence