Manager, US Regulatory Affairs & Compliance
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.
• 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.
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.
- 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).
• 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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Job posted: 2020-12-30