Pharma Regulatory & Commercial Counsel
Celltrion USA
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Job summary
Celltrion USA, the U.S. subsidiary of Celltrion, is seeking a Legal Manager to support FDA regulatory, marketing, market access, and contract matters.
The role involves advising on legal strategy, reviewing materials for compliance, and enabling commercial success across departments. Reporting to the Director, Legal, you will collaborate across functions, draft and review commercial agreements, and help ensure ethical, compliant communications and pricing strategies for biosimilar products in
Qualifications
- 5+ years as lawyer for a pharmaceutical company.
- Strong knowledge of Life Science Compliance and FDA advertising and promotions law.
- Experience with general commercial contracting and external communications legal concerns.
Responsibilities
- Review promotional, nonpromotional and scientific materials and help develop strategies for US medical affairs and marketing plans.
- Provide legal and regulatory advice to Marketing, Sales, Patient Support, and Medical Affairs teams.
- Review and draft contracts (MSA, SOWs, CDAs) and assess compliance risks in consultation with the Director, Legal.
- Advise on customer relations, regulatory matters, and biosimilar contract matters.
- Collaborate with other legal colleagues to advance company objectives and support training for employees.
Skills
Education
Job description
Celltrion USA, the U.S. subsidiary of Celltrion, is seeking a Legal Manager to support FDA regulatory, marketing, market access, and contract matters.
The role involves advising on legal strategy, reviewing materials for compliance, and enabling commercial success across departments. Reporting to the Director, Legal, you will collaborate across functions, draft and review commercial agreements, and help ensure ethical, compliant communications and pricing strategies for biosimilar products in
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