Let’s talk about some of the key responsibilities of the role:
Coordinates and compiles regulatory submissions for OPDP.
Act as a liaison between the Marketing, Legal, Medical and Regulatory teams for advertising and Promotional Review Committee.
Screens and coordinates approval of advertising and promotional materials
Successfully track data and act as electronic document repository administrator on an on-going basis.
Coordinate with fellow team members on projects as needed.
Ability to exercise project management in related areas.
Effectively communicate project needs and deliverables to regulatory management as needed.
Manage and work directly with outside vendors.
Will be exposed to compliance, legal, GMP, etc.
Regulatory review of promotional material, labeling content, product and process changes and product documentation.
Exercise judgment within defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Ensure schedules and performance requirements are met.
Skills and Qualifications Required for this Dynamic Team Member:
Bachelors’ degree or equivalent desired
1-3 years’ experience in Regulatory Affairs specifically in advertising and promotion roles preferred (US, Canada and Europe).
Experience in pharmaceutical labeling, advertising and promotion is required.
Proficiency with Microsoft Programs such as: Excel, PowerPoint, Word, etc.
Experience working with eCTD format.
Proven excellent communication skills while simultaneously able to work independently.
Highly self-motivated, self-directed and detail-oriented.
Effective planning, organizational and task management skills.
Strong negotiating and problem-solving skills.
Demonstrated ability to balance multiple projects with tight deadlines.
Strong attention to detail and ability to follow through.
Ability to stay calm in stressful environment.
Ability to independently manage multiple projects over extended periods of time
A Few Other Items Worth Mentioning:
Office location – Irvine
This position reports directly to the Director, Quality and Regulatory Affairs
Travel up to 5%
Evolus takes pride in being a company on the forefront of innovation. Employee welfare is no different. Here at Evolus, we don’t just work together, we’ve built a culture where we actually like each other! Because of this, you’ll find yourself immersed in an environment that not only promotes collaboration and team building, but game days and group lunches too! And that’s just the tip of the iceberg. Don’t believe us? Join our team and see for yourself! EOE M/F/D/V. For more information, please visit our website at www.evolus.com.
Additional Salary Information: Base, Bonus and Equity
Internal Number: Promo-Reg Affairs
Evolus, Inc. is a medical aesthetics company focused on providing physicians and their patients with expanded choices in medical aesthetic treatments and procedures. We are seeking an eager, goal oriented Regulatory Affairs Specialist. This individual is someone who can thrive in a collaborative environment as well as succeed independently. If you are looking for an opportunity to showcase your abilities while growing your knowledge, 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.