Associate Director, Global Regulatory Affairs - Labeling Lead

job summary:
If you thrive on steering high-stakes global labeling strategy-from CCDS creation to FDA and EMA negotiations-this is your platform. Take ownership of labeling for life-changing plasma therapies and drug-device combination products, leading cross-functional teams and cutting through complexity to shape product messaging worldwide.

location: Cambridge, Massachusetts
job type: Contract
salary: $100 - 131 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Drive global regulatory labeling strategy and lifecycle management for CCDS, US, and EU labels across plasma-derived therapies.
• Lead cross-functional labeling teams and align stakeholders across Clinical, Safety, Legal, and Commercial functions.
• Interpret scientific and clinical data to develop prescribing information while ensuring compliance with FDA and EMA regulations.
• Manage end-to-end labeling updates, submission-ready components, tracking systems, and document version control.
• Provide strategic guidance on drug-device combination product labeling and health authority submission plans.

 
qualifications:
Required:

• Bachelor's or Master's degree.
• Minimum of 7-10 years of experience in the biopharmaceutical industry (e.g., safety, ad promo, regulatory strategy, medical affairs, etc.) with 5-7 years of direct experience in a global, US, or EU labeling role.
• Must have a detailed understanding of pharmaceutical drug and device development and global regulations pertaining to labeling, specifically, EU and US labeling requirements and guidance.
• Expertise in the development and maintenance of the Company Core Data Sheet, the USPI, and the EU SmPC.
• Understanding of SPL format, requirements and guidance for legacy and PLR labels.
• Proficiency in Electronic Document Management Systems and End-to-End (E2E) Labeling Tracking Systems to support labeling documentation, tracking, and compliance activities.

Preferred:

• Advanced scientific or health sciences degree or equivalent relevant experience.
• Experience in plasma-derived therapies and biologics.
• Previous leadership experience and management of direct reports.
• Combination product/drug-device labeling knowledge.
• Advertising and promotion knowledge.

#LI-KH1

skills: Marketing Authorization Application (MAA), FDA Submissions


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.