Regulatory Affairs Manager - Remote

Overview

Evolus is a performance beauty company with a customer-centric approach focused on delivering breakthrough products. We are seeking an experienced and driven Regulatory Affairs Manager to join our Regulatory Team. This role demands technical depth and a high bar for quality. If you join our team, you will be working on some of the most exciting opportunities and challenges we face, with a team that values growth, recognition, and camaraderie. In this role, you will be challenged to drive the success of Evolus in an effort to build a brand like no other.

In Short

• Responsible for the preparation, compilation, submission, and submission tracking of US, EU, UK, Australian, Canadian and global regulatory drug and biologic submissions for Evolus’ products.
• Maintain relationships and work with external publishing vendors to ensure all submissions to Global Health Agencies are submitted per agreed timelines and with exceptional quality.
• Manage regulatory assessment and guidance on product compliance topics including change controls, deviations and GMP investigations.
• Provide regulatory support and guidance to cross-functional teams and key stakeholders.
• Assist in determining regulatory requirements for registration, approval, and maintenance of existing drug/biologics and potential new drug products in global markets.
• Establish clear priorities and bring key projects to completion on time, within budget and of significant impact to the growth of the business.
• Effectively communicate project needs and deliverables to R&D and upper management as needed.
• Other duties as assigned.

Requirements

• Bachelor’s degree (or 5+ years of experience in related field).
• Strong proven hands-on Regulatory Affairs experience (3+ years) and knowledge of regulatory submission and maintenance requirements for US and global filings (EU, UK, Canada, Australia, etc.) for drug/biologic products.
• Effective planning, organizational and task management skills.
• Ability to balance multiple projects with tight deadlines.
• Detail-oriented and goal-driven individual.
• Excellent facilitation and creative problem-solving skills.
• Excellent communication skills while simultaneously being able to work independently.
• Demonstrated ability to prepare complex documents/submissions and presentations.
• Knowledge of manufacturing processes associated with drugs and biologics.
• Experience in working with regulatory documentation systems and IT systems for regulatory document maintenance.

Benefits

• Fully Remote Optional.
• Office Location - Newport Beach (hybrid onsite Tuesday, Wednesday and Thursday) / Monday + Friday remote optional.
• Position reports directly to Vice President, Regulatory Affairs-Drug.
• Some travel may be required.
• Competitive suite of medical, dental and vision benefits.
• 401k match offered by Evolus.
• New hire equity and long-term incentives in the form of RSUs, stock options, and/or discretionary bonuses.
• Flexible paid time off program.
• Holiday soft closure between Christmas and New Years.
• Regularly catered team meals and a fully stocked kitchen.