Principal Scientist CMC RA

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 https://www.jnj.com

Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Regulatory Science

Job Category:
Scientific/Technology

All Job Posting Locations:
PL002 Iłżecka

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

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. Communicates critical issues to Management

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 Managem...