Director of Clinical Regulatory Strategy

Azuritypharmaceuticals; Raleigh (NC); Hybrid; USD 130,000 - 160,000; Full time

Benefits offered by this job

Competitive compensation package

Comprehensive health coverage

Hybrid work model

401K matching plan

Generous time off policy

Tuition reimbursement

Peer recognition platform

Job summary

Azurity Pharmaceuticals is looking for a Regulatory Affairs Director – Clinical Strategy in Raleigh, NC. This pivotal role involves developing strategies that align with regulatory requirements, representing the company in key regulatory discussions, and leading a talented team.

The ideal candidate will possess over 10 years of experience in Regulatory Affairs and a background in clinical writing. The position supports a hybrid work model, ensuring a balance between collaboration and flexibility.

Qualifications

• Over 10 years of experience in the pharmaceutical industry within Regulatory Affairs.
• 5+ years in regulatory clinical strategy and clinical writing for marketing applications.
• Strong communication skills with the ability to convey complex information clearly.

Responsibilities

• Develop and implement clinical regulatory strategies.
• Evaluate clinical documents to support successful regulatory objectives.
• Interact with clinical development teams for protocol reviews.

Skills

Regulatory writing

Team leadership

Analytical thinking

Communication

Education

Bachelor’s degree in a scientific discipline

Advanced degree preferred (MS, PharmD, PhD)

Job description

Azurity Pharmaceuticals is looking for a Regulatory Affairs Director – Clinical Strategy in Raleigh, NC. This pivotal role involves developing strategies that align with regulatory requirements, representing the company in key regulatory discussions, and leading a talented team.

The ideal candidate will possess over 10 years of experience in Regulatory Affairs and a background in clinical writing. The position supports a hybrid work model, ensuring a balance between collaboration and flexibility.