Senior Manager Regulatory Affairs

ABOUT US:

Built around our mission, we started AG more than a decade ago as a way to bring comprehensive and convenient daily nutrition to just about everybody. Originators of the Essentialist Nutrition movement, our philosophy is to focus on a very small number of products based on what the latest science indicates is essential to human health.

AG1 is made from the highest quality ingredients, in accordance with the strictest standards and obsessively improved based on the latest science. 75 vitamins, minerals, and whole-food sourced nutrients in one convenient daily serving. Optimized for athletes, life-letes, and everyone in between. Vegan, Paleo, and Keto-friendly. One scoop or travel packet, 8 ounces of water. Every day. That's it.

Our mission is to empower people to take ownership of their health.

THE ROLE:

In this newly created role, Athletic Greens is seeking an experienced Senior Manager, Regulatory Affairs to lead product compliance matters and support AG’s growth by ensuring that the company's products are manufactured, labeled, and marketed in compliance with all applicable regulations and laws.

The successful candidate will have a proven track-record of providing regulatory guidance, analysis and leadership in the dietary supplement space. This role will be responsible for the strategic direction, development and implementation of regulatory policies, processes and programs to enable continued global growth and international expansion of products sold by AG. Reporting to the Chief Legal Officer, this position will help build the newly created Regulatory Affairs Department and work cross-functionally with key internal stakeholders, including our Quality and Research, Nutrition & Innovation Teams as well as Customer Happiness. The ideal candidate is a highly collaborative and experienced self-starter who can work independently and productively with minimal direction, routinely exercises sound judgment and is excited about building processes that allow the company to move quickly.

WHAT YOU’LL DO:

• Provides early preliminary regulatory assessments for all formulas, ingredients, and innovations for all countries of interest before formula approval
• Provide support for regulatory review of publications and clinical trial materials.
• Develop and implement standard operating procedures (SOPs) ensuring compliance with the company's policies and FDA regulations
• Contribute to the development of regulatory strategy for specific projects, including identifying and assessing regulatory risks
• Anticipate and advise on future regulatory trends and direction, and frequently recommend preemptive approaches for company regulatory compliance
• Provide regulatory guidance and prepare responses for audits, inspections, recalls, etc.
• Review and approve new and/or revised labels and ensure labeling content and product documentation is developed in accordance with regulatory requirements.
• Work with internal and external regulatory counsel
• Develop a system to track and monitor regulatory changes and updates, and ensure that our products and processes are updated accordingly
• Review formula, raw material and finished product specifications to ensure compliance with regulatory requirements.
• Compile, review, approve, and submit clinical trial and marketing registration applications, amendments, and supplements.
• Work with Product Development team to develop ingredients list and nutritional panel based on formula
• Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
• Review and submit Adverse Health Events and Report Serious Adverse Events to the FDA as required.
• Build strong partnerships with the Quality and Research, Nutrition & Innovation teams to ensure product compliance
• Prepare and process documentation required for product registrations, notifications and certifications in applicable international markets

WHAT WE’RE LOOKING FOR:

• Minimum of 8+ years of demonstrated Regulatory Affairs experience and in-depth knowledge of regulatory requirements in the Dietary Supplement industry.
• Sound critical thinking skills. You can identify opportunities, anticipate challenges and gaps, and contingency plan accordingly.
• Bachelor's Degree in Science, Nutrition or related field preferred, or a combination of education and equivalent work experience.
• Experience in the US regulatory landscape required; understanding of international product regulations preferred, particularly in EU, UK and APAC.
• Experience interacting with the Food and Drug Administration and other regulatory authorities.
• Experience improving processes in order to enable business growth at scale.
• Experience in label and formula review.
• Strong attention to detail and a proven ability in managing time and tasks associated with fast-paced organization.
• Strong interpersonal, written communication, and organizational skills
• A “builder” who is excited at the prospect of creating a Regulatory Affairs Department, embracing any opportunity to “roll up their sleeves” to achieve desired outcomes.
• Excellent team player with a demonstrated ability to successfully participate in cross-functional teams, with the ability to summarize and communicate risk and technical details in a business-friendly way.
• Skilled in forming relationships with and working with multiple stakeholders, both internal and external, in a remote-first or remote-only environment that is multiple geography and multiple time zones.
• Experience with drafting, implementing and training on regulatory related SOPs.
• Strong attention to detail and a proven ability in managing time and tasks associated with fast-paced organization.

WHAT'S IN IT FOR YOU?

• Employer paid short-term disability and life insurance.
• Paid holidays and an unlimited vacation policy to ensure you have a healthy work-life balance.
• Annual company-wide retreats and quarterly department-wide meet-ups (COVID permitting).
• A monthly fitness class credit to support you on your health and fitness journey.
• Access to Athletic Greens product and swag items.
• The opportunity to work with passionate, high-growth, business-minded colleagues.
• A mission-driven approach to each and everything that we do, with an overall goal to significantly improve our customer's health and wellness.
• A brand new company laptop and a generous home-office budget so you can work your best.
• 90% premium coverage for top medical, dental and vision plans.
• A 401k plan with company-matching because life is an opportunity and we care about your future.
• A 100% remote working environment, which has been implemented from day one.
• Paid maternity and paternity leave to allow you to spend time with your new family.
• An immensely strong company culture that is enforced through the hiring process ensures values alignment and a highly collaborative team.

AG is dedicated to providing equitable and competitive compensation & benefits packages. For this particular role, the base salary range is $115,000 - $150,000 and will ultimately be decided at the offer stage, based on an individual candidate’s level of skills and experience aligned with the needs of this role. Base salary is one component of total compensation for this position. We provide a competitive mix of base salary, performance bonus, and stock option allocation for eligible roles.

Athletic Greens is an Equal Opportunity Employer. We are committed to inspiring fulfilling lives, starting with a focus on health and we believe this starts in the workplace. We do this by providing employees with a safe and welcoming work environment free of discrimination and harassment. We strive to create a diverse & inclusive environment where all team members can thrive, feel a sense of belonging, and make a difference in the world together. We do not discriminate based on age, race, color, religion, sex, sexual orientation, gender identity, national origin, pregnancy, veteran status, disability, or any other status protected by law. We are an equal opportunity employer.