Manager, Regulatory Affairs

Responsibilities

• Manage advertising and promotional submissions (2253s) related to the BLA and serve as RA representative on the Promotional Review Committee
• Translate local, regional and international regulatory requirements into workable plans with cross-functional teams
• Manage preparation, review and submission of regulatory documents across non-clinical, clinical and CMC modules for IND/CTA, BLA/MAA and global submissions
• Collaborate with contributing authors on submission content, including meeting packages, responses, supplements and annual reports
• Interact with regulatory agencies on defined matters
• Mentor, guide and train direct reports
• Travel up to 15%

Requirements

• Bachelor's degree and 5+ years directly related experience
• Direct experience in promotional material review
• Knowledge of FDA OPDP requirements

Preferred Qualifications

• Degree in Chemistry, Biology, Pharmaceutical Science or related field
• 5-7 years pharmaceutical Regulatory Affairs experience with drugs/biologics
• Regulatory Affairs certification or equivalent training
• eCTD preparation, submission and lifecycle management experience
• Knowledge of US, EU, Health Canada, Australia and ICH requirements
• Experience directly interfacing with regulatory authorities

Benefits

• Competitive compensation including base salary and annual performance bonus
• Flexible PTO, holidays and parental leave
• Healthcare benefits, HSA and 401k match, life and disability insurance, wellness discounts

About the Company

Revance develops, produces and distributes differentiated products across aesthetics, skincare and therapeutics.