Evolus
Sr. 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 Sr. Regulatory Affairs Manager to join our Regulatory Team. This role demands a high bar for quality and attention to detail. 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 development of US and global regulatory strategy, identifying key regulatory issues, deliverables and remediation activities needed throughout the product/project lifecycle for Drugs and Biologic products.Represent Regulatory Affairs on key activity and project teams.Responsible for providing regulatory support and guidance to cross-functional teams and key stakeholders.Lead the planning, authoring, submission, maintenance and review of regulatory submissions for Evolus’ products in all key markets.Engage in regulatory submissions and interaction with Agencies worldwide.Provides input on regulatory topics to licensing partners.Establish clear priorities and bring new opportunities to completion on time, within budget and of significant impact to the growth of the business.Effectively communicate project needs and deliverables to upper management as needed.Skills and Qualifications Required for this Dynamic Team Member:
Master’s degree (or 10+ years of experience in related field).7+ years of experience in the pharmaceutical/biotechnology industry, 5 of which are in Regulatory Affairs.Strong proven hands-on Regulatory Affairs experience and knowledge of 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 able to work independently.Demonstrated ability to prepare complex documents/submissions and presentations.A Few Other Items Worth Mentioning:
Office Location - Newport Beach (hybrid onsite Tuesday, Wednesday and Thursday) / Remote (Monday and Friday).Position reports directly to Vice President, Regulatory Affairs.Some travel may be required.Compensation & Total Rewards
The expected pay range for this position is $165,000 to $201,800. 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 promotes not only respect, collaboration, and team building but also a community. 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
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Responsible for development of US and global regulatory strategy, identifying key regulatory issues, deliverables and remediation activities needed throughout the product/project lifecycle for Drugs and Biologic products.Represent Regulatory Affairs on key activity and project teams.Responsible for providing regulatory support and guidance to cross-functional teams and key stakeholders.Lead the planning, authoring, submission, maintenance and review of regulatory submissions for Evolus’ products in all key markets.Engage in regulatory submissions and interaction with Agencies worldwide.Provides input on regulatory topics to licensing partners.Establish clear priorities and bring new opportunities to completion on time, within budget and of significant impact to the growth of the business.Effectively communicate project needs and deliverables to upper management as needed.Skills and Qualifications Required for this Dynamic Team Member:
Master’s degree (or 10+ years of experience in related field).7+ years of experience in the pharmaceutical/biotechnology industry, 5 of which are in Regulatory Affairs.Strong proven hands-on Regulatory Affairs experience and knowledge of 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 able to work independently.Demonstrated ability to prepare complex documents/submissions and presentations.A Few Other Items Worth Mentioning:
Office Location - Newport Beach (hybrid onsite Tuesday, Wednesday and Thursday) / Remote (Monday and Friday).Position reports directly to Vice President, Regulatory Affairs.Some travel may be required.Compensation & Total Rewards
The expected pay range for this position is $165,000 to $201,800. 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 promotes not only respect, collaboration, and team building but also a community. 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
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