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Senior Technical Manager, US Regulatory Affairs & Compliance - Full-time / Part-time
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Northbrook, IL Northbrook, Illinois |
About this job
Job Summary
Responsible for providing leadership and accountability for US-led Regulatory Affairs and Compliance for WAG Owned Brand products and Global Brands. Responsible for developing strategies and executing regulatory affairs and compliance programs related to claims, label compliance, regulatory intelligence, regulatory compliance and product safety. Provides cross-functional support regarding regulatory matters to ensure compliant product release and maintenance. Collaborates and provides global regulatory insight to our partners to assure adherence to global policy and procedures where company products are manufactured and sold.
Job Responsibilities
* Sets systematic processes for business partners to maintain compliance to laws, rules and regulations.
* Provides leadership and subject matter expertise regarding regulatory compliance for product innovation with product brief development, claim substantiation and review.
* Provides product-specific regulatory compliance at the global, regional and state/locale-specific level to include label/pack copy review, product registration and licensing, 3rd party endorsements.
* Keeps abreast of and shares business relevant regulatory requirements and developing changes on the horizon that will affect the organization's product portfolio.
* Transfers knowledge of product integrity across functional lines, promoting cross-functional teamwork and empowerment to achieve established objectives related to product integrity, technical development and regulatory compliance.
* Translates strategic goals into actionable plans in the delivery of quality assurance and product and program regulatory compliance for Global Brands.
* Develops and mentors staff through on-boarding, open communication, training and development opportunities and performance management processes; builds and maintains employee morale and motivation; ensures the team is appropriately staffed with required competencies; fosters a diverse and inclusive workplace.
#LI-BC1
Walgreens, one of the nation's largest drugstore chains, is included in the Retail Pharmacy USA Division of Walgreens Boots Alliance, Inc., the first global pharmacy-led, health and wellbeing enterprise. More than 10 million customers interact with Walgreens each day in communities across America, using the most convenient, multichannel access to consumer goods and services and trusted, cost-effective pharmacy, health and wellness services and advice. Walgreens operates 8,175 drugstores with a presence in all 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands. Walgreens omnichannel business includes Walgreens.com. Approximately 400 Walgreens stores offer Healthcare Clinic or other provider retail clinic services.
As the neighborhood drugstore and retailer, our goal is to make health and happiness simpler, easier and within reach. And we remain a trusted wellness provider offering convenient access to important health services, such as immunizations and an array of pharmacy services that can help patients improve their health. To our team members, Walgreens represents a unique opportunity to excel in their careers in a welcoming and inclusive environment. We offer the chance to work in a truly supportive environment, and be a part of a progressive organization dedicated to the well-being of our customers, team members and the communities we all call home.
Basic Qualifications
* Bachelor's Degree in a scientific discipline and at least 4 years of experience in consumer packaged goods, research and development, or government regulations related to Regulatory Affairs and/or Compliance OR a High School Diploma and at least 7 years of experience in consumer packaged goods, research and development, or government regulations related to Regulatory Affairs and/or Compliance.
* Experience interpreting state and federal regulations and maintaining working relationships with industry and regulatory officials.
* Strong knowledge of domestic and international regulations, guidelines and industry standards in regions where are our products are manufactured or sold.
* Experience in developing and implementing regulatory documentation, processes and procedures.
* Strong background and understanding of US FDA laws as well as CPSCA laws and regulations.
* Label review and claims substantiation experience.
* Strong risk management skills with the ability to raise risks and propose mitigations.
* 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 both internal and external resources to develop strategies that meet department goals within budget and established timelines.
* 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 directly managing people, including hiring, developing, motivating, and directing people as they work.
* Willing to travel up to 10% of the time for business purposes (within state and out of state).
Preferred Qualifications
* Experience in Private/Owned Brands.
* Experience in technical roles in Research and Development, Quality, Manufacturing, or Procurement.
* Experience managing product or vendor programs in the retail or CPG industry.
* Experience managing vendor compliance.
Apply Save jobSaved
Responsible for providing leadership and accountability for US-led Regulatory Affairs and Compliance for WAG Owned Brand products and Global Brands. Responsible for developing strategies and executing regulatory affairs and compliance programs related to claims, label compliance, regulatory intelligence, regulatory compliance and product safety. Provides cross-functional support regarding regulatory matters to ensure compliant product release and maintenance. Collaborates and provides global regulatory insight to our partners to assure adherence to global policy and procedures where company products are manufactured and sold.
Job Responsibilities
* Sets systematic processes for business partners to maintain compliance to laws, rules and regulations.
* Provides leadership and subject matter expertise regarding regulatory compliance for product innovation with product brief development, claim substantiation and review.
* Provides product-specific regulatory compliance at the global, regional and state/locale-specific level to include label/pack copy review, product registration and licensing, 3rd party endorsements.
* Keeps abreast of and shares business relevant regulatory requirements and developing changes on the horizon that will affect the organization's product portfolio.
* Transfers knowledge of product integrity across functional lines, promoting cross-functional teamwork and empowerment to achieve established objectives related to product integrity, technical development and regulatory compliance.
* Translates strategic goals into actionable plans in the delivery of quality assurance and product and program regulatory compliance for Global Brands.
* Develops and mentors staff through on-boarding, open communication, training and development opportunities and performance management processes; builds and maintains employee morale and motivation; ensures the team is appropriately staffed with required competencies; fosters a diverse and inclusive workplace.
#LI-BC1
Walgreens, one of the nation's largest drugstore chains, is included in the Retail Pharmacy USA Division of Walgreens Boots Alliance, Inc., the first global pharmacy-led, health and wellbeing enterprise. More than 10 million customers interact with Walgreens each day in communities across America, using the most convenient, multichannel access to consumer goods and services and trusted, cost-effective pharmacy, health and wellness services and advice. Walgreens operates 8,175 drugstores with a presence in all 50 states, the District of Columbia, Puerto Rico and the U.S. Virgin Islands. Walgreens omnichannel business includes Walgreens.com. Approximately 400 Walgreens stores offer Healthcare Clinic or other provider retail clinic services.
As the neighborhood drugstore and retailer, our goal is to make health and happiness simpler, easier and within reach. And we remain a trusted wellness provider offering convenient access to important health services, such as immunizations and an array of pharmacy services that can help patients improve their health. To our team members, Walgreens represents a unique opportunity to excel in their careers in a welcoming and inclusive environment. We offer the chance to work in a truly supportive environment, and be a part of a progressive organization dedicated to the well-being of our customers, team members and the communities we all call home.
Basic Qualifications
* Bachelor's Degree in a scientific discipline and at least 4 years of experience in consumer packaged goods, research and development, or government regulations related to Regulatory Affairs and/or Compliance OR a High School Diploma and at least 7 years of experience in consumer packaged goods, research and development, or government regulations related to Regulatory Affairs and/or Compliance.
* Experience interpreting state and federal regulations and maintaining working relationships with industry and regulatory officials.
* Strong knowledge of domestic and international regulations, guidelines and industry standards in regions where are our products are manufactured or sold.
* Experience in developing and implementing regulatory documentation, processes and procedures.
* Strong background and understanding of US FDA laws as well as CPSCA laws and regulations.
* Label review and claims substantiation experience.
* Strong risk management skills with the ability to raise risks and propose mitigations.
* 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 both internal and external resources to develop strategies that meet department goals within budget and established timelines.
* 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 directly managing people, including hiring, developing, motivating, and directing people as they work.
* Willing to travel up to 10% of the time for business purposes (within state and out of state).
Preferred Qualifications
* Experience in Private/Owned Brands.
* Experience in technical roles in Research and Development, Quality, Manufacturing, or Procurement.
* Experience managing product or vendor programs in the retail or CPG industry.
* Experience managing vendor compliance.
Apply Save jobSaved