Senior Manager, Regulatory Affairs – Global Labeling
Salary: $175,000–$195,000 base
This is a hybrid onsite position – relocation is provided
A growing biopharmaceutical company is seeking an experienced regulatory labeling professional to support global labeling activities for marketed and development-stage products. This role will coordinate labeling strategy, documentation, and implementation while working closely with cross-functional and international teams.
Responsibilities:
- Develop and maintain US and international labeling documents, including CCDS, prescribing information, medication guides, patient leaflets, and package artwork.
- Lead cross-functional labeling reviews, approvals, and implementation of product labeling changes.
- Manage labeling project plans, deadlines, and communications with internal stakeholders.
- Research regulatory requirements and labeling precedents to inform compliant labeling strategies.
- Prepare or support labeling components of regulatory submissions and responses to health authority questions.
- Coordinate with international partners, translation vendors, and local regulatory resources.
- Collaborate with Supply Chain, Quality, and Regulatory colleagues on global packaging artwork.
- Track evolving FDA, EU, and international labeling requirements and evaluate their impact.
- Maintain labeling records and trackers; contribute to SOPs and process improvements.
Requirements:
- Bachelor’s degree in a scientific or related discipline; advanced degree preferred.
- 3–6 years of regulatory labeling experience in the pharmaceutical or biotechnology industry.
- Experience developing and maintaining US and EU pharmaceutical labeling; broader international experience is a plus.
- Experience representing Regulatory Affairs on cross-functional teams and driving projects to completion.
- Knowledge of FDA and international health authority labeling regulations and guidance.
- Strong scientific review, communication, stakeholder management, and organizational skills.
- Experience with Veeva Vault RIM and QualityDocs is preferred.
- Ability to manage competing priorities and collaborate across international time zones; occasional travel may be required.
How to Apply
We’d love to see your resume, but we don’t need it to have a conversation. Send us an email and tell us why you’re interested, or feel free to send your resume directly to Tom@ScientificSearch.com.
#LI-TO1
#LI – HYBRID