Global Product Compliance Specialist

3 days ago


Waltham, Massachusetts, United States Lifelancer Full time

At Lifelancer, we are seeking an experienced Global Product Compliance Specialist to join our team in Waltham, MA, USA. This is a full-time opportunity for a mid-senior level professional with expertise in regulatory affairs and quality management.

About the Role

We are looking for a skilled expert to support our development and new registration projects, ensuring compliance with regulatory requirements. The successful candidate will have experience in project management, change control processes, and knowledge of relevant regulations such as registration of medicinal products, GxP, EU requirements, CMC, ICH M4, etc.

Key Responsibilities
  • Support development and new registration projects, ensuring compliance with regulatory requirements
  • Project manage the implementation of projects to comply with regulatory requirements
  • Organize submission-readiness of regulatory documentation (e.g., CMC relevant parts)
  • Manage global teams within change projects
  • Provide expert interface function to the development department, marketing, production, quality department, and regional/local approval unit
Requirements
  • Bachelor's or Master's degree in a relevant field (technical or scientific studies)
  • Experience in project management or change control process (at least 3-5 years)
  • Background in regulatory affairs or quality environment, preferably in pharmaceutical/medical industry
  • Fluent English language skills, advanced German language skills
  • Strong communication and teamwork skills
Our Offer

We offer a competitive salary range $80,000 - $120,000 per year, depending on experience. Our package includes:

  • A unique opportunity to work in a dynamic, innovative company
  • The chance to contribute to the success of our clients in the life sciences industry
  • A supportive team environment with opportunities for professional growth and development
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off

Lifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, and IT domains. If you are passionate about regulatory affairs and quality management, apply now to take your career to the next level



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