Senior Regulatory Affairs Lead – NA (Hybrid)

Azurity Pharmaceuticals - Ireland; Raleigh (NC); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work model

Annual bonus based on company and个人表现

401K with company match up to 5%

Healthcare coverage (medical, dental,视

Vacation 15 days + rollover; 5 sick/w】

Job summary

Azurity Pharmaceuticals is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products and projects. The role requires serving as the regulatory representative on cross-functional teams, guiding submissions for US and Canada, and ensuring compliance with regulations and commitments.

The ideal candidate will manage IND, NDA, ANDA, NDS, and DMF filings, interact with the FDA and Health Canada, and drive strategic regulatory plans across North America.

Qualifications

• Bachelor of Science or higher in life sciences or equivalent.
• 10+ years in pharmaceutical industry with at least 8 years in regulatory affairs.
• Combination of education and applicable job experience may be considered.
• Excellent organizational, interpersonal, verbal, and written communication skills; strong grammar and editing.
• Proven track record working with cross-functional teams and external partners.
• Ability to work independently in a fast-paced, deadline-driven environment.

Responsibilities

• Represent Regulatory Affairs on project teams and provide regulatory guidance.
• Interface with FDA and Health Canada; prepare briefing documents and attend meetings.
• Drive regulatory strategies for drug product registration and lifecycle management in NA.
• Manage regulatory filings (IND, NDA, ANDA, NDS, DMF) for various dosage forms; respond to agency requests.
• Establish timelines for regulatory submissions and maintain submission archives.
• Provide regulatory guidance for post-approval changes and lifecycle activities.

Skills

Regulatory affairs leadership

FDA liaison

Project management

Cross-functional collaboration

Education

Bachelor of Science in life sciences

Tools

MS Office

Job description

Azurity Pharmaceuticals is seeking a Regulatory Affairs Manager to oversee regulatory activities for assigned products and projects. The role requires serving as the regulatory representative on cross-functional teams, guiding submissions for US and Canada, and ensuring compliance with regulations and commitments.

The ideal candidate will manage IND, NDA, ANDA, NDS, and DMF filings, interact with the FDA and Health Canada, and drive strategic regulatory plans across North America.