Principal Legal Counsel, Quality, Regulatory & Manufacturing

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profile Job Location:

Warren, OH - USA

profile Monthly Salary: $ 216487 - 297669
Posted on: 7 days ago
Vacancies: 1 Vacancy

Job Summary

Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve grown evolved and are now entering an exciting new chapter one filled with bold ambitions and enormous opportunity.

Our trusted portfolio of brands including Sensodyne Panadol Advil Voltaren Theraflu Otrivin and Centrum lead in resilient and growing categories. What sets us apart is our unique blend of deep human understanding and trusted science.

Now its time to fully realise the full potential of our business and our people. We do this through our Win as One strategy. It puts our purpose to deliver better everyday health with humanity at the heart of everything we do. It unites us inspires us and challenges us to be better every day driven by our agile performance-focused culture.

About the role

Haleon operates in a highly regulated global environment where manufacturing quality product safety and regulatory compliance are critical to consumer trust and business continuity. As regulatory expectations continue to evolveparticularly around ingredients manufacturing systems and oversight of suppliers and thirdparty manufacturersthe business faces increasing complexity and risk.

To support Haleons growth strategy and manage these risks the Principal Legal Counsel Quality Regulatory & Manufacturing provides deep expertise in quality regulatory and good manufacturing practices partnering closely with the QSC function. Regulators are applying more rigorous and nuanced requirements across global supply chains and advanced product portfolios and ambiguity in inspection and enforcement expectations creates material enforcement and reputational risk.

The Principal Legal Counsel Quality Regulatory & Manufacturing delivers senior level legal counsel in key markets while providing strategic oversight to enable consistent defensible decision making across manufacturing sites and regions. This role serves as a senior specialist advisor offering strategic guidance during inspections and regulatory interactions and advising on product safety and ingredient risk including emerging restrictions on ingredients contaminants and chemical classes. This includes counsel on ingredient bans global and local risk assessments mitigation strategies and product safety governance decisions that directly impact formulation market access and supply continuity. This expertise is critical to:

  • Protecting Haleons licence to operate

  • Maintaining regulatory credibility

  • Reducing reliance on external legal counsel

  • Enabling confident timely decision making across manufacturing sites and region

Key Responsibilities:

  • Strategic legal partner to the QSCP function in the areas of quality compliance regulatory and manufacturing.

  • Collaborate with senior QSCP leaders globally and regional operating units legal leads to enable project and deal outcomes aligned with strategic priorities support company goals comply with legal requirements and adequately mitigate risk.

  • Key Legal Lead across - global quality compliance recall procedures manufacturing and regulatory best practices and delivering strategy to deliver our ESG/environmental-related manufacturing goals

  • Key legal partner oningredient-related regulatory risk includingglobal and local ingredient bans and restrictions contaminants and impurities risk mitigation and strategy and emerging chemical regulatory regimes ensuring legally defensible science baseddecision makingacross product portfolios.

  • Regulatory Compliance: Provide legal advice on healthcare-specific regulations affecting manufacturing and distribution including FDA and EU regulations U.S. state licensing requirements other and supply chain requirements.

  • Serve asseniorlegal advisor tocross-functional product risk and safety governance forums providing legal judgment on escalation risk acceptance market action and remediation decisions for product safety and compliance issues.

Why you

Basic Qualifications:

  • Juris Doctor (JD) or equivalent law degree with admission to practice law in at least one relevant jurisdiction.

  • 10 years experience providing legal counsel in highly regulated manufacturing environments with a strong focus on quality product safety and regulatory compliance.

  • Prior experience working as in-house counsel in a matrixed organization.

  • Demonstrated knowledge and expertise combined in the understanding of the consumer health FDA and regulated manufacturing landscape

  • Proven ability to provide strategic legal guidance during inspections and regulatory interactions including delivering consistent defensible interpretations of regulatory requirements.

  • Demonstrated experience advising on product safety and ingredient risk including emerging and evolving regulatory restrictions on ingredients contaminants and chemical classes.

  • Strong capability to advise on ingredient bans and restrictions global and local risk assessments and mitigation strategies impacting product formulation market access and supply continuity.

  • Proven ability to operate effectively in environments involving regulatory ambiguity evolving expectations and high enforcement and reputational risk.

  • Strong cross-functional collaboration skills with experience partnering across Quality Manufacturing Regulatory Supply Chain Compliance and Commercial teams.

  • Demonstrated ability to support global decision making enabling consistent approaches across manufacturing sites regions and operating units.

  • Excellent judgment and decision making skills with the ability to enable confident timely decisions while balancing regulatory compliance business continuity and risk mitigation.

  • Strong communication and influencing skills including the ability to translate complex regulatory requirements into clear actionable guidance for senior leaders.

Preferred Skills:

  • Prior experience as a senior inhouse regulatory or manufacturing counsel within a global regulated consumer health pharmaceutical or life sciences organization.

  • Direct experience advising on FDA EU and U.S. state regulatory requirements affecting manufacturing and distribution.

  • Deep expertise in good manufacturing practices (GMP) and the regulatory frameworks governing manufacturing quality systems and supply chains.

  • Experience supporting global supply chains including oversight of suppliers and third-party manufacturers.

  • Background advising on recall procedures manufacturing compliance issues and regulatory best practices at a global level.

  • Experience contributing to or leading legal strategy supporting ESG or environmental-related manufacturing goals.

  • Demonstrated ability to reduce reliance on external legal counsel through strong internal expertise and leadership.

  • Experience operating in environments with advanced product portfolios and heightened regulatory scrutiny.

Location: This role is based in based in Warren NJ and follows a hybrid model requiring an in-office presence of 3 days per week.

Compensation: The salary range for this role is:$216487 - $297669 plus an 18% on-target annual bonus.

#Li-Hybrid

Benefits

Haleon offers a robust Total Reward package that consists of competitive pay and a comprehensive benefits program. This includes a generous 401(k) plan tuition reimbursement and time off programs including 6 months paid parental leave. On day one you are eligible for benefits including our healthcare programs where the company pays for the majority of your medical coverage for you and your family. We also offer the opportunity to receive a discretionary bonus based on the achievement of key business performance and other incentive/recognition programs as part of the offering.

Job Posting End Date

Equal Opportunities

Haleon are committed to mobilising our purpose in a way that represents the diverse consumers and communities who rely on our brands every day. It guides us in creating an inclusive culture where different backgrounds and views are valued and respected all in support of understanding and best serving the needs of our consumers and unleashing the full potential of our people. Its important to us that Haleon is a place where all our employees feel they truly belong.

During the application process we may ask you to share some personal information which is entirely voluntary. This information ensures we meet certain regulatory and reporting obligations and supports the development refinement and execution of our inclusion and belonging programmes that are open to all Haleon employees.

The personal information you provide will be kept confidential used only for legitimate business purposes and will never be used in making any employment decisions including hiring decisions.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license Haleon may be required to capture and report expenses Haleon incurs on your behalf in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleons compliance to all federal and state US Transparency requirements.

Accommodation Requests

If you require a reasonable accommodation or other assistance to apply for a job at Haleon at any stage of the application process please contact us by sending an email to Please include the following in your email:

Use subject line: Haleon Careers: Job Accommodation Request

Your Name and contact information

Requisition ID and Job Title you are interested in

Location of Requisition (city/state or province/country)

Description of specific accommodation you are requesting

Please note: Resumes CVs or other requests outside of accommodation support submitted to this email box will not be accepted.

Note to candidates

The Haleon recruitment team will contact you using a Haleon email account (@). If you are not sure whether the email you received is from Haleon please get in touch.


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Welcome to Haleon. Were a purpose-driven world-class consumer company putting everyday health in the hands of just three years since our launch weve grown evolved and are now entering an exciting new chapter one filled with bold ambitions and enormous opportunity.Our trusted portfolio of brands i...
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About Company

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About us We are a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have 3 global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.

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