Evolus
Regulatory Affairs Manager
Evolus, Newport Beach, California, us, 92659
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.Key Responsibilities:
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 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.Skills and Qualifications Required:
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 skillsAbility to balance multiple projects with tight deadlinesDetail-oriented and goal-driven individualExcellent facilitation and creative problem-solving skillsExcellent communication skills while simultaneously being able to work independentlyDemonstrated ability to prepare complex documents/submissions and presentationsKnowledge of manufacturing processes associated with drugs and biologics.Experience in working with regulatory documentation systems and IT systems for regulatory document maintenance.Additional Information:
Office Location - Newport Beach (hybrid onsite Tuesday, Wednesday and Thursday) / Monday + Friday remote optionalPosition reports directly to Vice President, Regulatory Affairs-DrugSome travel may be requiredCompensation & Total Rewards
The expected pay range for this position is $125,840 to $152,300. 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.
#J-18808-Ljbffr
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 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.Skills and Qualifications Required:
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 skillsAbility to balance multiple projects with tight deadlinesDetail-oriented and goal-driven individualExcellent facilitation and creative problem-solving skillsExcellent communication skills while simultaneously being able to work independentlyDemonstrated ability to prepare complex documents/submissions and presentationsKnowledge of manufacturing processes associated with drugs and biologics.Experience in working with regulatory documentation systems and IT systems for regulatory document maintenance.Additional Information:
Office Location - Newport Beach (hybrid onsite Tuesday, Wednesday and Thursday) / Monday + Friday remote optionalPosition reports directly to Vice President, Regulatory Affairs-DrugSome travel may be requiredCompensation & Total Rewards
The expected pay range for this position is $125,840 to $152,300. 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.
#J-18808-Ljbffr