Manager, Global Regulatory Affairs, CMC

Purpose: The Principal Scientist of Global Regulatory Affairs CMC is responsible for developing global CMC regulatory strategies and dossier content plans according to scientific/risk-based principles in consultation with their supervisor. The primary responsibility is to lead the CMC regulatory activities related to large molecules in clinical development and post marketing in all global markets. Principal Scientist will support CMC Teams and provide directions on the interpretation and application of global CMC regulations and strategical guidance related to Large Molecules.

You will be responsible for:

• Participate as the Regulatory CMC Lead on CMC/Value Chain Teams and represent CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally.

• Actively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements and commitments.

• Develop and execute global CMC regulatory strategy for one or more drug and/or delivery device, large molecule, vaccine, cell and gene therapy product(s).

• Lead the preparation of regulatory dossiers for submission to Health Authorities.

• Develop and gain agreement with project teams on the regulatory CMC strategy for Health Authority responses/interactions as needed.

• May lead/participate in selected initiatives within CMC RA / Global Regulatory Affairs (GRA).

• Drive a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management.

• May represent CMC RA on Cross Functional Teams.

• May serve as a Single Point of Contact (SPOC)/Subject Matter Expert (SME) on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise.

• Ensure the CMC development and commercial product regulatory strategy meets global regulatory requirements over the lifecycle of the product and is in alignment with the strategies of GRA, the therapeutic area, commercial, regional functions and the Quality Target Product Profile (QTPP).

• Assure connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader).

• Escalate issues to CMC RA Management that affect registration, regulatory compliance and continued lifecycle management of the product.

• Develop and update contingency plans for issues that may affect registration, regulatory compliance and the continued lifecycle management of the products in scope.

• Effectively and tactfully communicate with health authorities; build positive relationships and maintain good rapport and credibility.

• Review CMC regulatory dossiers for global submissions throughout the product lifecycle.

• Provide accurate regulatory assessments of CMC changes to teams/projects and executes regulatory planning and implementation.

Qualifications / Requirements:

• A BS/BA in biological, pharmaceutical, chemical or engineering sciences is required with a minimum of 8+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent. An MS, Ph.D., or Pharm. D. degree is preferred.

• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is required.

• Experience in biologics, product development/LCM of the large molecules is required.

• Experience developing regulatory strategies and an understanding of product development is preferred.

• Knowledge of EU and FDA regulations is preferred.

• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results.

• High-level verbal and written communication skills. Strong attention to detail.

• The ability to potentially travel up to 10% travel, domestic and/or international.

Required Skills:

Preferred Skills:

Benchmarking, Coaching, Consulting, Corporate Governance, Critical Thinking, Drug Discovery Development, Fact-Based Decision Making, Healthcare Trends, Interpersonal Influence, Organizing, Public Policies, Regulatory Compliance, Regulatory Development, Scientific Research, Strategic Thinking, Subject Matter Experts (SME) Collaboration, Technical Writing