Regulatory Compliance Specialist

6 days ago


Billerica, Massachusetts, United States Sequoia Biotech Consulting Full time
Job Summary

We are seeking a highly skilled Sr. Process Engineer to join our team at Sequoia Biotech Consulting.

About the Role

The successful candidate will leverage their expertise in quality systems, change management, label lifecycle management, project management, and process improvements to drive compliance, efficiency, and innovation in packaging and labeling.

About the Company

Sequoia Biotech Consulting is a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale, and quality of life-saving innovations.

Responsibilities
  • Maintain and enhance packaging and labeling quality systems to ensure compliance with FDA, EMA, and related regulations.
  • Develop/improve standard operating procedures (SOPs), work instructions, and quality documentation related to packaging and labeling processes with a focus on lifecycle management.
  • Lead and implement change management strategies for packaging and labeling, supporting product lifecycle changes and minimizing operational impact.
  • Manage and review label change requests (LCR) to ensure timely, accurate, and compliant label updates.
  • Collaborate with regulatory, quality, and manufacturing teams to evaluate and execute changes, supporting a first-time-right approach.
  • Plan, execute, and oversee packaging and labeling projects from concept through implementation, ensuring alignment with product launch timelines and regulatory requirements.
Requirements
  • Bachelor's degree in Engineering, regulatory affairs, or a related field.
  • Minimum of 7-11 years of experience in pharmaceutical packaging and labeling, with specific expertise in sterile injectables and medical devices.
  • Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to packaging and labeling, and experience filing label artwork changes.
  • Proficiency with quality systems including change control and quality events, proficiency in labeling equipment, label artwork review and compliance.
  • Demonstrated success in managing multiple projects in parallel.
  • Excellent communication skills with the ability to work effectively across departments and influence stakeholders.
What We Offer
  • Competitive salary ranging from $125,537.14 to $188,305.70 per year, based on location and experience.
  • A comprehensive Total Rewards Program, including excellent healthcare options, family focus and balance, financial security, tuition reimbursement, and employee recognition programs.
Equal Employment Opportunity

Sequoia Biotech Consulting is an equal employment opportunity employer and welcomes applications from diverse candidates.



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