What are the responsibilities and job description for the Regulatory Labelling Consultant position at i-Pharm GxP?
Regulatory Labeling Consultant – On-Site in North Billerica, MA
Initial Contract through December 31st, 2025
W2 Only | Competitive Hourly Rate
We are seeking a highly skilled Regulatory Labeling Consultant to join a leading pharmaceutical organisation in North Billerica, MA. This is a critical role focused on ensuring regulatory compliance and improving labeling processes for sterile injectables and medical devices.
Key Responsibilities:
- Oversee and maintain regulatory labeling systems to ensure compliance with FDA, EMA, and related global standards.
- Manage and implement label change requests (LCR) to support product lifecycle updates and regulatory submissions.
- Collaborate with cross-functional teams, including regulatory, quality, and manufacturing, to ensure label updates meet both regulatory and internal requirements.
- Identify and implement process improvements to enhance efficiency, compliance, and risk mitigation within labeling workflows.
- Drive labeling projects from initiation to execution, ensuring timelines align with regulatory and product launch requirements.
- Provide technical expertise and support for labeling issues, ensuring all label specifications adhere to global regulatory standards.
Qualifications:
- Bachelor’s degree in Regulatory Affairs, Engineering, or a related field.
- 3-5 years of experience in regulatory labeling within the pharmaceutical or medical device industry, with specific expertise in sterile injectables.
- Strong knowledge of cGMP, FDA, EMA, and USP guidelines.
- Experience with label artwork changes, regulatory submissions, and quality systems.
- Proven ability to manage multiple projects simultaneously and collaborate with cross-functional teams.
This is an excellent opportunity to contribute to high-impact projects with a global pharmaceutical leader. Apply today to learn more!
Hamish Corson
Senior Business Manager | USA | GxP Contract Division
1 646 536 4736 (USA)
HCorson@i-pharmconsulting.com
