Senior Scientist CMC Regulatory AffairsScience

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:
Warsaw, Masovian, Poland

Job Description:

We are searching for the best talent for Senior Scientist CMC Regulatory Affairs to be in Warsaw (Poland)

 

Purpose: The CMC Regulatory Affairs Scientist contributes to the development of global CMC regulatory strategies, dossier plans and submissions in collaboration with other CMC RA personnel

 

You will be responsible for:


* Assist in execution of the development strategy that meets global regulatory requirements over the lifecycle of the product.


* Support global regulatory filings for development compound and marketed products in collaboration with/under supervision of other CMC RA senior personnel.


*
+ Develop CMC content and dossier plans
+ Assist in the preparation of dossiers for submission to Health Authorities (NDA/BLA/MAA/IND/CTA and post approval variations).
+ Preparing country specific required documents to global submissions
+ Prepare CMC RA submissions for renewals and annual product submissions
+ Prepare responses to Health Authority questions or other communications


* Provide CMC Regulatory support to Health Authority inspections

 

Qualification / Requirements:


* BS in engineering, biology, pharmaceutical or chemical sciences with generally a minimum of 3-6 years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience.

MS., PhD, or Pharm.

D.

degrees preferred.


* Good verbal and written communication skills.

Good organizational skills.

Strong attention to detail.


* Proficient understanding of biology, chemistry and/or engineering relevant to pharmaceutical products.


* Understanding scientific principles for the manufacture of drug substance and drug product and/or devices.


* General knowledge of drug development and lifecycle management.

 

 

Required Skills:

 

 

Preferred Skills:
Analytical Reasoning, Coaching, Communication, Consulting, Controls Compliance, Corporate Governance, Critical Thinking, Data Governance, Drug Discovery Development, Healthcare Trends, Public Policies, Regulatory Compliance, Regulatory Development, Relationship Building, Risk Compliance, Scientific Research, Technical Writing, Technologically Savvy