Regulatory Affairs Director, CMC

Evolus, Inc. is a performance beauty company focused on providing physicians and their patients with expanded choices in medical aesthetic treatments and procedures. We are seeking a seasoned, technically proficient Regulatory Affairs Director, CMC. This individual is someone who can thrive in a fast-paced, innovative environment to help develop and drive the success of regulatory affairs. If you are looking for an opportunity to grow your knowledge and abilities in a unique environment, then look no further! In this role, you will be challenged to drive the success of Evolus in an effort to build a brand like no other.  Let’s talk about some of the key responsibilities of the role: 

• Responsible for the development of US and global CMC regulatory strategy, identifying key regulatory issues, deliverables, and remediation activities needed throughout the product/project lifecycle for Drug and Biologics products.
• Represent Regulatory Affairs CMC on key activity and project teams
• Responsible for providing CMC regulatory support and guidance to cross-functional teams and key stakeholders
• Lead the planning, authoring, submission, maintenance, and review of CMC sections of regulatory submissions for Evolus’ products in all key markets
• Engage in CMC regulatory submissions and interaction with Agencies worldwide.
• Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
• Establish clear priorities and bring new opportunities to completion on time, within budget, and of significant impact on the growth of the business
• Effectively communicate project needs and deliverables to upper management as needed

 Skills and Qualifications Required for this Dynamic Leader: 

• Master’s degree (or 13+ years of experience in a related field)
• 10+ years of experience in the pharmaceutical/biotechnology industry, 7 of which are in CMC Regulatory Affairs.
• Strong proven hands-on CMC Regulatory Affairs experience and knowledge of CMC regulatory submission requirements for global filings is required.
• Knowledge of manufacturing processes associated with drugs and biologics.
• Experience working with Contract Manufacturers and Outsource Suppliers of regulatory services.
• Effective planning, organizational, and task management skills
• Ability to balance multiple projects with tight deadlines
• Strong attention to detail and ability to follow through
• 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.

A Few Other Items Worth Mentioning: 

• Office location – Newport Beach but working remotely is a potential option for the right candidate
• This position reports directly to the Vice President, Regulatory Affairs
• Some travel will be required

 Compensation & Total Rewards:The expected pay range for this position is $200,000 to $275,000.  Your actual base salary will be determined on a case-by-case basis and may vary based on a number of considerations including but not limited to role relevant knowledge and skills, experience, education, certifications, and more. We offer more than just a paycheck, and your base salary is just the start! Stay happy and healthy with our competitive suite of medical, dental and vision benefits to help you feel your best and be your best. We also provide those benefits you shouldn’t have to worry about, from employer covered life insurance to short-term disability. Take advantage of the 401k match offered by Evolus and let us invest in your future. You may also be eligible for new hire equity and long-term incentives in the form of RSUs, stock options, and/or discretionary bonuses.  We offer mental health and wellbeing resources for you to develop skills to find your calm, boost your confidence, and show up as your best self in work and life. Travel or relax and come back feeling refreshed with our flexible paid time off program for exempt employees and a paid time off accrual plan for non-exempt employees.  Did we mention the holiday soft closure between the Christmas and New Years holidays? We have that, too.  Additional perks include regularly catered team meals at our Evolus Headquarters, a fully stocked kitchen (Kombucha & Coffee included), and the opportunity to join an organization where our values of Grit, Impact, Fun, and Transparency are displayed daily. Evolus takes pride in being a company on the forefront of innovation, while being committed to conducting its business with the highest degrees of integrity, professionalism, and social responsibility. We are also committed to complying with all laws and regulations that apply to our business. Employee welfare is no different. Here at Evolus, we don’t just work together, we’ve built a culture of inclusion! Because of this, you’ll find yourself immersed in an environment that not only promotes respect, collaboration and team building, but a community too. And that’s just the tip of the iceberg. Join our team and see for yourself! EOE M/F/D/V. For more information, please visit our website at www.evolus.com. Apply