Evolus is a performance beauty company with a customercentric 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.
Let’s talk about some of the key responsibilities of the role:
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.
Responsible for maintaining relationships and working 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.
Responsible for providing regulatory support and guidance to crossfunctional 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
Skills and Qualifications Required for this Dynamic Team Member:
Bachelor’s degree (or 5 years of experience in related field)
Strong proven handson 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
Detailoriented and goaldriven individual
Excellent facilitation and creative problemsolving 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.
Position reports directly to Vice President Regulatory AffairsDrug
Some travel may be required
Compensation & Total Rewards
The expected pay range for this position is $125840 to $152300. Your actual base salary will be determined on a casebycase basis and may vary based on a number of considerations including but not limited to rolerelevant 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 shortterm 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 longterm 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 nonexempt 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
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.