Director, Global Regulatory Affairs
New
A
Angitia BiopharmaceuticalsBiotechnology
U.S (Remote)Full-TimeDirector
Salary180,000 - 230,000 USD per year
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Job Details
- Experience
- 10+ years of pharmaceutical or biotechnology experience, including at least 8 years in Regulatory Affairs strategy.
Requirements
- Hold a bachelor's degree in Life Sciences or a related discipline; an advanced degree such as PharmD, MS, PhD, or MBA is preferred.
- Have 10+ years of pharmaceutical or biotechnology experience, including at least 8 years in Regulatory Affairs strategy.
- Bring significant experience supporting global development programs through registration and lifecycle management.
- Have strong knowledge of regulatory requirements and frameworks in the US, EU, and Japan.
- Have experience leading health authority interactions, including with FDA, EMA, and PMDA.
- Have experience developing major regulatory submissions and regulatory strategies.
- Demonstrate the ability to lead and influence cross-functional matrix teams.
- Have experience working in multinational and multicultural environments.
- Experience in rare disease, orphan drug development, or other specialized development pathways is preferred but not required.
Responsibilities
- Lead global regulatory strategies for assigned development programs.
- Lead product Global Regulatory Teams and represent Regulatory Affairs on governance and cross-functional development teams.
- Provide regulatory leadership across nonclinical, clinical, CMC, registration, and lifecycle management activities.
- Partner with cross-functional teams on development plans, study designs, endpoints, and regulatory pathways.
- Identify regulatory risks and opportunities and recommend mitigation and management approaches.
- Lead health authority interaction strategy and execution, including meeting preparation, briefing materials, and responses.
- Oversee major regulatory submissions, including INDs, CTAs, amendments, and marketing applications.
- Direct global and regional submission strategies with regional regulatory stakeholders.
- Monitor evolving regulatory requirements and assess their potential impact on development programs.
- Mentor junior regulatory professionals and contribute to departmental initiatives and process improvements.
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