Principal Scientist, CMC Regulatory Affairs

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Johnson & Johnson Innovative Medicine is recruiting a Principal Scientist in Global CMC Regulatory Affairs - Synthetics, Established Modalities., covering both pre- and post-approval activities. This position is located in Warsaw, Poland.

The Principal Scientist in CMC Regulatory Affairs will be responsible for the following:

• Participates as the CMC (chemistry, manufacturing and control) Regulatory Lead on CMC/Value Chain 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 comply with local regulatory requirements and commitments.

• Develops and executes global CMC regulatory strategy for one or more synthetic drugs and/or delivery device, meeting .

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

• Develops and gets buy-in on CMC regulatory strategy for Health Authority responses as needed.
• Participates 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 & Johnson standards, regulatory requirements and expectations. Communicates critical issues to Management

• 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.

• Escalates issues to CMC Regulatory Affairs Management that affect registration, regulatory compliance and continued lifecycle management of the product.
• Develops and updates 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 relationship and credibility.
• Reviews CMC regulatory dossiers for global submissions throughout the product lifecycle.
• Provides accurate regulatory assessments of CMC changes and executes regulatory planning and implementation.

• 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