Job Summary:

The Lead, Regulatory Operations is responsible for managing Regulatory Affairs activities (nonclinical, clinical and CMC) for assigned investigational development products from preclinical candidate designation through product approval, including regulatory submissions. This individual is responsible for maintaining an in-depth awareness of relevant federal and international regulations and policies to optimize Revance’s regulatory input to assigned projects and teams.

Reporting to: Associate Director, Regulatory Affairs
Location: Newark, CA or remote

Responsibilities/Essential Duties:

• Executes regulatory strategies for earliest possible approvals for Revance development programs.
• Maintains knowledge of local, regional, and international regulatory requirements.
• Manages the drafting/review/compiling of IND/CTA, BLA/MAA, Structured Product Labeling (SPL such as Drug Listing, Establishment Registration, lot distribution data, etc.), and other global submissions documents; may manage e-submission vendors.
• Collaborates on submission content with contributing authors across functional areas to achieve clarity and regulatory compliance (INDs, CTAs, BLAs/NDAs, meeting packages, responses, supplements, annuals).
• Ensures timely preparation of organized and scientifically valid applications.
• Administrates and maintains Regulatory tools and systems such as, but not limited to, the Veeva RIM Vault electronic document management system (EDMS), Accenture StartingPoint authoring templates, Adobe Acrobat add-ins, department SharePoint sites, and department network drives.
• Trains end users on Regulatory tools and systems.
• Business lead in Computerized System Validation (CSV) activities for Regulatory Systems.
• Responsible for executing regulatory documentation infrastructure, including paper and electronic submissions.
• Provides Operational support for the Regulatory Affairs team including archiving, formatting, document processing, authoring tool support, and timeline/project management.
• Authors and maintains Regulatory controlled and uncontrolled documentation including Standard Operating Procedures (SOP), Work Instructions (WI), and other aids.
• Collaborates with IT Business Partners.
• May be required to travel up to 15%.

Basic Qualifications:

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Science or a related field.
• Minimum of 7 years in pharmaceutical Regulatory Operations with a focus in drugs/biologics.
• Experience in preparation, submission and lifecycle management of investigational/marketing applications in eCTD format.
• Knowledge of US, EU, Health Canada, China, Australia, and ICH regulatory requirements.
• Experience in preparing Advertising and Promotional submissions with materials from Veeva Vault PromoMats including metadata management and FORM FDA 2253 form population.
• Experience with Business Administration of Veeva RIM Vault.
• Must be Proficient in MS Office Suite (Word, Excel, PowerPoint, Outlook).
• Strong written and verbal communication.
• Proficient in Adobe Acrobat Pro and ISI Toolbox.
• Experience with Project Management tools: eg. SmartSheet and MS Project.

Preferred Qualifications:

• 8 years’ in pharmaceutical Regulatory Operations with a focus in drugs/biologics.
• Experience using CDER Direct.
• Experience coordinating SPL with ReedTech.
• Experience working with external consultants and external publishers.
• Knowledge of MAC operating systems.

Company Summary:

As a commercial-stage biotechnology company focused on innovative aesthetic and therapeutic offerings, Revance is setting the new standard for its clients through disruptive products, and for its employees through industry-leading benefits, which promote financial and physical well-being for all. It’s time to rethink everything you thought an employee experience could be.

What Revance invests in you:

• Competitive Compensation including base salary, annual target bonus, and new hire equity
• Flexible unlimited PTO, summer & winter shutdowns, and 12 weeks’ parental leave
• Generous healthcare benefits (Company pays up to 90% of premiums for medical benefits), Employer HSA contribution, 401k match, ESPP program with 15% discount on RVNC stock, tuition reimbursement, wellness discounts and much more

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.” 

We are an equal opportunity employer. We are a company where diverse backgrounds, experience and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual’s race, color, national or ethnic origin, religion, age sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.