Principal Scientist (Manager), Global Regulatory Affairs, CMC

Johnson & Johnson Innovative Medicine • Horsham, PA

3d • $117,000 - $201,250 • Hybrid

About The Position

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.

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.
• 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.
• 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.

Nice To Haves

• An MS, Ph.D., or Pharm. D. degree is preferred.
• Experience developing regulatory strategies and an understanding of product development is preferred.
• Knowledge of EU and FDA regulations is preferred.

Responsibilities

• 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period 10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Principal