Jobs and Careers

Sr. Regulatory Affairs Manager

Newport Beach, United Statesfull_timeVerifiedPosted 26 Sept 2024

💰 $201,800/yr($165,000/yr – $201,800/yr)

About the role

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 med