CMC Regulatory Expert

2 weeks ago

Cork, Cork, Ireland beBeeRegulatory Full time €80,000 - €120,000
Job Title: Regulatory Scientist

Job Summary:

This role is a crucial part of our global marketing authorization submission management processes. As a Regulatory Scientist, you will partner with GRA-CMC Regulatory Scientists to lead and manage the various aspects of global marketing authorization submissions.

The successful candidate will have a strong working knowledge of global regulations, guidelines, and regulatory precedence, as well as technical knowledge of CMC development and manufacturing processes.

You will be responsible for providing regulatory support for existing Drug Substances and Drug Products by preparing and maintaining the appropriate regulatory submission documentation needed to obtain and maintain marketing authorizations.

In this role, you will also partner with GRA-CMC Regulatory Scientists to manage outsourcing activities and contract manufacturers, ensure successful preparation of CMC dossiers and variation packages, and provide regulatory leadership and support for products listed as primary responsibilities.

Additionally, you will develop, plan, and execute appropriate regulatory strategies and on agreed-upon priorities through effective partnership with GRA-CMC Regulatory Scientists and other functional representatives.

You will work collaboratively within a team or as an individual contributor to deliver on time product lifecycle management and manage submission timelines with relevant teams, monitor approval status, and communicate change status to interested personnel in a timely manner.

Key Responsibilities:

  • Provide regulatory support for existing Drug Substances and Drug Products
  • Partner with GRA-CMC Regulatory Scientists to manage outsourcing activities and contract manufacturers
  • Ensure successful preparation of CMC dossiers and variation packages
  • Provide regulatory leadership and support for products listed as primary responsibilities

Requirements:

  • Minimum a college degree (BSc), ideally an advanced degree (MSc, PhD, PharmD preferred) in related biological and life science field
  • Strong knowledge of regulatory and compliance guidelines within pharmaceuticals/bio-pharmaceuticals
  • Strong knowledge of Manufacturing & Quality work processes as well as GMP compliance

Benefits:

Our company offers a premium workspace with flexible hybrid working options, healthcare, pension, and life assurance benefits, subsidized canteen, onsite gym, travel subsidies, and on-site parking. We also offer in-house People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives to enhance your career experience.

Work Environment:

Our company values diversity, equity, and inclusion and caters to all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities, and gender. We are committed to creating a disability confident culture both at our organization and beyond.

What We Offer:

Be Creative, Be an Innovator, and most of all, Be Yourself.

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