Senior Scientist CMC Regulatory AffairsScience

2 dni temu

Warszawa, Mazovia, Polska Johnson & Johnson Innovative Medicine Pełny etat

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

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

  • Senior Scientist CMC Regulatory AffairsScience

    6 godzin temu

    Warszawa, Mazovia, Polska Johnson & Johnson Innovative Medicine Pełny etat

    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...

  • Senior Scientist CMC Regulatory AffairsScience

    6 godzin temu

    Warszawa, Mazovia, Polska Johnson & Johnson Pełny etat

    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...

  • CMC RA Director, New Modalities

    6 dni temu

    Warszawa, Mazovia, Polska Johnson & Johnson Innovative Medicine Pełny etat 80 000 zł - 150 000 zł rocznie

    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...

  • CMC RA Director, New Modalities

    6 dni temu

    Warszawa, Mazovia, Polska Johnson & Johnson Innovative Medicine Pełny etat 120 000 zł - 180 000 zł rocznie

    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...

  • Regulatory Affairs Manager

    6 dni temu

    Warszawa, Mazovia, Polska Randstad Polska Pełny etat 60 000 zł - 120 000 zł rocznie

    We are seeking a highly skilledRegulatory CMC Managerto play a vital role in shaping global regulatory strategies for innovative pharmaceutical products. In this position, you will lead the preparation of regulatory dossiers, collaborate with cross-functional teams, and provide expert guidance to ensure compliance and successful product development. This is...

  • Senior Global Regulatory Scientist

    1 tydzień temu

    Warszawa, Mazovia, Polska ICON plc Pełny etat 60 000 zł - 120 000 zł rocznie

    Senior Global Regulatory ScientistICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentSenior Global Regulatory ScientistSouth Africa, UK, Ireland, Poland,...

  • Client Onboarding

    2 dni temu

    Warszawa, Mazovia, Polska CMC Markets Pełny etat

    We are hiring a Client Onboarding Supervisor to join us here at CMC Markets. In this pivotal role, you'll oversee the full client onboarding journey — ensuring accuracy, compliance, and excellence at every stage. You'll lead a talented team of KYC professionals, drive process improvements, and collaborate across global regions to deliver a seamless...

  • Customer Onboarding

    2 dni temu

    Warszawa, Mazovia, Polska CMC Markets Pełny etat

    We are hiring a Client Onboarding Supervisor to join us here at CMC Markets. In this pivotal role, you'll oversee the full client onboarding journey — ensuring accuracy, compliance, and excellence at every stage. You'll lead a talented team of KYC professionals, drive process improvements, and collaborate across global regions to deliver a seamless...

  • CMC Project Manager

    1 tydzień temu

    Warszawa, Mazovia, Polska Carbyne Consulting Pełny etat 60 000 zł - 80 000 zł rocznie

    Join our Biotech PMO as aCMC Project Manager, driving biosimilar development programs through scale-up and commercialization. You'll operate within the CMC Coordination Group, ensuring cross-functional alignment across process development, analytical sciences, and manufacturing. ResponsibilitiesLead end-to-end CMC planning for biosimilar assetsDefine scope,...

  • Regulatory Scientist

    2 dni temu

    Warszawa, Mazovia, Polska ICON plc Pełny etat

    Regulatory ScientistICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentThe Regulatory Scientist completes country and, or regional Clinical Trial...