Manager, US Regulatory Affairs & Compliance at Walgreens

| North Suburbs
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Job Summary

Responsible for guiding and managing the regulatory strategy for the Walgreen’s Owned Brand Health & Wellness category in order to support achievement of key business goals. This role ensures all regulatory considerations related to claims, product labeling and FDA requirements on Owned Brand Medical Devices, OTCs and Supplements are properly vetted. Monitors, evaluates and interprets FDA regulations in the Medical Device, OTC and Supplement space. Partners cross-functionally with brand owners, global sourcing, vendors, third party testing labs, Global Quality Technical staff and Legal counsel to ensure compliant product release and maintenance. Advises other team leaders within Quality Technical Americas team on Medical Device, OTC and Supplement regulatory issues and represents the team with senior members of the company.

Job Responsibilities

• Acts as the regulatory compliance subject matter expert for Health & Wellness product innovation with product brief development, claim substantiation and review. Actively participates in stakeholder and vendor meetings to ensure project plan is compliant with all regulatory requirements while meeting key business objectives and timelines.
• Evaluates best practices, methodology and resources for continuous process improvement. Develops and implements documentation and process to maintain alignment and ensure compliance to laws, rules and regulations across the Owned Brands business.
• Provides regulatory compliance support through product label and claims review, review of third party testing results and review of vendor technical documentation.
• Transfers application of Regulatory knowledge across functional lines, promoting cross-functional teamwork and empowerment to achieve established objectives related to product integrity, technical development and regulatory compliance.
• Monitors changes in US regulations related to Medical Devices, OTCs and Supplements. Assesses business impact, flags changes, and provides recommendations on best regulatory approach to ensure compliance.
• Responsible for the implementation process of new regulatory approaches.

Walgreens Disclaimer

An Equal Opportunity Employer, including disability/veterans Walgreens (walgreens.com), one of the nation's largest drugstore chains, is included in the Retail Pharmacy USA Division of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), a global leader in retail and wholesale pharmacy. Walgreens is proud to be a neighborhood health, beauty and retail destination supporting communities across the country, and was named to FORTUNE* magazine’s 2019 Companies that Change the World list. Approximately 8 million customers interact with Walgreens in stores and online each day. As of August 31, 2019, Walgreens operates 9,277 drugstores with a presence in all 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands, along with its omnichannel business, Walgreens.com. Walgreens also provides specialty pharmacy and mail services and offers in-store clinics and other health care services throughout the United States, most of which are operated by our health care strategic partners.

Basic Qualifications

  • Bachelor’s degree and at least 4 years of experience in Regulatory Affairs and/or Compliance OR a High School diploma/GED and at least 7 years of experience in Regulatory Affairs and/or Compliance.
  • Experience interpreting state and federal regulations and maintaining working relationships with industry and regulatory officials.
  • Experience in developing and implementing regulatory documentation, processes and procedures.
  • Experience with US FDA laws as well as CPSCA laws and regulations.
  • Scientific background and ability to discuss technical matters with cross-functional team members, third party labs and vendors.
  • Experience with label reviews and claims substantiation.
  • Experience with risk management and mitigation.
  • Experience with analyzing and reporting data in order to identify issues, trends, or exceptions to drive improvement of results and find solutions.
  • Experience collaborating with Legal counsel to assess risk on complex regulatory issues.
  • Highly organized, demonstrates excellent research and communication skills, and pays close attention to detail.
  • Intermediate level skill in Microsoft Excel (for example: using SUM function, setting borders, setting column width, inserting charts, using text wrap, sorting, setting headers and footers and/or print scaling).
  • Intermediate level skill in Microsoft PowerPoint (for example: applying a theme, formatting character spacing, inserting a picture, changing slide layout and theme colors, adding transitions, customizing slide numbers, changing chart style and/or formatting font).
  • At least 2 years of experience planning, developing, and managing departmental expense and capital budgets.
  • At least 2 years of experience of direct leadership and/or cross functional team leadership.
  • Willing to travel up to 10% of the time for business purposes (within state and out of state).

Preferred Qualifications
• Experience in CPG Private/Owned Brands regulatory support.
• Knowledge of FDA regulations, regulatory submissions and labeling requirements pertaining to Class I and II Medical Devices, OTCs and Supplements including familiarity with 510ks, UDIs, NDA, ANDA and Drug Monographs.
• Experience in CPG technical roles in Research and Development, Quality, Manufacturing, Procurement or Government Affairs related to Medical Device, OTCs and/or Supplements.
• Experience in identifying, interpreting and assessing the impact of domestic and international regulations on Medical Device, OTCs and Supplements.
• Regulatory knowledge in food/beverage and beauty personal care categories.
• Experience managing product or vendor compliance programs in the retail or CPG industry.
• At least 2 years of experience of direct leadership and/or cross functional team leadership.

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Technology we use

  • Engineering
  • Product
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Location

Developed and diverse suburb in N.Chicago. Opening our new Tech Office downtown at the Old Chicago Post Office in January 2020!

An Insider's view of Walgreens

What’s the vibe like in the office?

You can expect to be challenged, every day. You can also expect an extraordinarily diverse environment of collaborative professionals who are putting their talents together to fulfill the vision and mission. There are plenty of opportunities to make an impact, to grow and to learn with the team. The future of Technology is bright at Walgreens!

Carlos

Director, RunOps

What does your typical day look like?

I'm a part of the product management team where I oversee the development of complex products. A typical day for me involves juggling multiple product lines, I could easily find myself working with designers to craft mockups, defining requirements for developers, tracking development processes, or running usability tests to drive product forward.

Katrina

Sr. Business Analyst

What makes someone successful on your team?

I think the most successful individuals are those who possess two key skills 1) the ability to quickly learn and synthesize information and 2) the ability to adapt to constantly changing challenges. Given the extremely complex nature of our industry,

Emmanuel

Sr. UX Designer

How do you empower your team to be more creative?

In Rx Engineering, we are building the largest pharmacy software product suites in the industry. Innovation and quality is our DNA. We nurture through our “COOL” culture to build curiosity in new solution. We are challenged and fascinated with courage every day about this engineering journey which will change our customers’ life.

Ronnie

Director – Solution Engineering & QE

How do your team's ideas influence the company's direction?

We are faced with a host of rapid changes occurring in the healthcare and retail landscapes.. To make the most of these changes, Walgreens is adapting to the fast moving technology world of today and is committed to deploying cutting edge solutions to support our business and customers.

Doug

Senior Product Manager, Pharmacy and Retail Operations

What are Walgreens Perks + Benefits

Walgreens Benefits Overview

Walgreens offers a wide variety of benefits to eligible team members designed to support your physical, financial, and emotional well-being while helping you balance work and life. In addition to company-paid life insurance and voluntary life & personal accident insurance, the benefits below are available to our team members. To learn more visit https://jobs.walgreens.com/benefits.

Culture
Volunteer in local community
Walgreens is proud to be a Corporate Social Responsibility leader, setting the pace on some of the most important issues of our day, and our IT and digital teams are no exception.
Partners with Nonprofits
Money raised through Red Nose Day supports programs that keep children safe, healthy and educated in America and around the world.
Friends outside of work
Eat lunch together
Intracompany committees
To learn more visit https://jobs.walgreens.com/it-culture
Daily stand up
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Open office floor plan
Diversity
Dedicated Diversity/Inclusion Staff
Highly diverse management team
Every day, in a multitude of ways, the foundational principles of integrity, respect and fair dealing embraced by our founder Charles R. Walgreen inspire us.
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Walgreens employees can contribute up to $500 annually to their FSA.
Disability Insurance
Disability insurance covers 6 weeks at 100% base pay, 6 weeks at 50% base pay. 50% benefit may be supplemented by PTO, frozen sick, or frozen vacation.
Dental Benefits
For dental coverage, you may choose from four plan levels ranging from a basic-only option to those with orthodontia and other major service coverage.
Vision Benefits
There are three levels of benefits for vision coverage ranging from an exam-only discount option to an enhanced PPO with both in and out-of-network benefits.
Health Insurance Benefits
You have access to competitive coverage options through the Benefits Support Center, which is the Walgreens private corporate exchange.
Life Insurance
Benefit-eligible team members are eligible for company-paid term life insurance at a benefit equal to: • 1.5 times annual base salary and $25,000 for all other hourly-paid team members
Wellness Programs
Onsite Gym
Team workouts
Walgreens team fitness initiatives include Sponsored race teams like the JP Morgan Chase Run.
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Walgreens provides employees with a 401(k) matching plan called the Walgreen Profit Sharing Plan. After completing one year, we match 4% of contributions $1 for $1.
Employee Stock Purchase Plan
After 90 days of service and an average of 20 hours worked per week, you are eligible to purchase WBA stock at a 10% discount off market value.
Performance Bonus
You are eligible for a corporate bonus subject to approval by the Board of Directors (unless you are covered under another bonus program).
Child Care & Parental Leave Benefits
Child Care Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home. Work remotely 2 days per week and/or work remotely on occasion as needed.
Family Medical Leave
Vacation & Time Off Benefits
Paid Holidays
Perks & Discounts
Casual Dress
Commuter Benefits
The Transportation Benefit Plan allows you to save money by paying for your transportation and parking needs with before-tax dollars and payroll deductions.
Game Room
Parking
Professional Development Benefits
Lunch and learns
Renewal host weekly Lunch and Learns on topics selected by our team.
Promote from within
Customized development tracks

Additional Perks + Benefits

Walgreens offers a wide variety of benefits to eligible team members designed to support your physical, financial, and emotional well-being while helping you balance work and life. To learn more visit https://jobs.walgreens.com/benefits.

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