Principal Scientist CMC RA Full-time

CMC Regulatory Affairs Team Member

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.

We are searching for the best talent for our CMC RA team to be based in Warsaw, Poland.

Principle Responsibilities

• Participates as the Regulatory CMC Lead on CMC/VST Teams and represents Global CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally
• Actively participates on Global Regulatory Team(s) to develop global submission plans that align with local regulatory requirements and commitments.
• Develop and implement global CMC regulatory strategy for one or more drug and/or delivery device, vaccine cell/gene therapy product(s).
• Leads the preparation of regulatory dossiers for submission to Health Authorities.
• Develop and get consensus on regulatory CMC strategy for Health Authority responses as needed
• May participate in selected initiatives within CMC RA / GRA
• Participates in and conducts due diligence/licensing evaluations as needed
• Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations.

Sphere of Authority

• Ensures 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 global regulatory affairs, the therapeutic area, commercial, regional functions and the Quality Target Product Profile (QTPP)
• Assures connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader).
• Refines regulatory strategies as new data become available.
• Raises issues to CMC Regulatory Affairs 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 communicates with health authorities; maintain good rapport and credibility.
• Reviews CMC regulatory dossiers for global submissions throughout the product lifecycle
• Provides accurate regulatory assessments of chemistry, manufacturing and control changes to teams/projects and completes regulatory planning and implementation.

Position Requirements

• BS in biological, pharmaceutical, chemical or engineering sciences with generally 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 preferred
• Demonstrated ability to communicate regulatory requirements.
• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry
• Experience developing regulatory strategies and an understanding of product development, seen as an expert on product development and how it is applied in global regulatory strategy.
• Strong attention to detail with high-level verbal and written communication skills
• Communicates cross-functionally and cross-company.
• Presents and defends CMC management-approved regulatory strategy and opinion to project teams.
• Demonstrates model behavior that understands what the priorities are and encourages others to drive for results Experience interacting with Health Authorities under supervision of a senior member of the CMC RA staff.
• Good knowledge of global HA laws, regulations, guidance and regulation submission routes available for assigned products.
• Some understanding of competitors in the area and what they are doing in early/late development