Remote Regulatory Affairs Manager – Global Submissions

Revance; United States; Remote; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive compensation includingBase

Flexible PTO

Generous healthcare benefits

Job summary

Revance is seeking a Regulatory Affairs Manager to lead regulatory activities across non-clinical, clinical, CMC and Ad Promo for investigational and marketed products. You will partner with internal and external stakeholders to ensure compliance and strategic alignment through the product life cycle.

The ideal candidate understands INDs, CTAs, BLAs, global authority interactions and promotional material reviews.

Qualifications

• Bachelor’s degree and 5+ years directly related Regulatory Affairs experience.
• Direct experience reviewing promotional materials and knowledge of FDA OPDP requirements.

Responsibilities

• Manage regulatory submissions (IND/CTA, BLA/MAA) and lifecycle documents across modules.
• Serve as RA representative on promotional review committees and advise cross-functional teams.
• Translate regulatory requirements into workable plans with internal/external stakeholders.
• Interact with regulatory agencies on defined matters and manage infrastructure for submissions.
• Mentor and train direct reports; travel up to 15% as needed.

Skills

Regulatory affairs

Promotional material review

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree

Chemistry/Biology/Pharmaceutical Science degree

Regulatory Affairs certification

Tools

eCTD submissions

Job description

Revance is seeking a Regulatory Affairs Manager to lead regulatory activities across non-clinical, clinical, CMC and Ad Promo for investigational and marketed products. You will partner with internal and external stakeholders to ensure compliance and strategic alignment through the product life cycle.

The ideal candidate understands INDs, CTAs, BLAs, global authority interactions and promotional material reviews.