Senior Regulatory Strategy Lead

Azurity Pharmaceuticals; Raleigh (NC); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Hybrid work model

Annual bonus

Health insurance

401K matching

Vacation days

Holidays

Tuition reimbursement

Job summary

Azurity Pharmaceuticals in the United States is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products and to serve as the regulatory representative on cross-functional teams.

You will author Health Authority submissions for US and Canada, shape regulatory strategies for drug product registration and lifecycle management, and liaise with FDA and Health Canada to ensure compliance and timely filings.

Qualifications

• Bachelor degree or higher in a health care discipline; PharmD/PhD/MS considered.
• 10+ years in pharmaceutical industry with 8+ years in regulatory affairs.
• Excellent organizational and communication skills; able to work with cross-functional teams.

Responsibilities

• Represent Regulatory Affairs on product teams and cross-functional projects.
• Provide regulatory assessment for due diligence and new business development.
• Serve as interface with FDA and Health Canada; prepare submissions and briefings.
• Drive regulatory strategy for drug product registration and lifecycle management.
• Manage regulatory filings (IND, NDA, ANDA, NDS, DMF) for various dosage forms.
• Coordinate timelines; maintain submission archives and logs.
• Offer regulatory guidance for post-approval changes and SLT/ELT meetings.
• Monitor evolving regulations and advise cross-functional teams.

Skills

Organizational skills

Interpersonal skills

Verbal communication

Written communication

Grammar & proofreading

MS Office

Cross-functional collaboration

Strategic regulatory thinking

Education

Bachelor of Science or higher health care degree

Tools

MS Office

Job description

Azurity Pharmaceuticals in the United States is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products and to serve as the regulatory representative on cross-functional teams.

You will author Health Authority submissions for US and Canada, shape regulatory strategies for drug product registration and lifecycle management, and liaise with FDA and Health Canada to ensure compliance and timely filings.