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Regulatory Affairs CMC Manager (US and Canada)

Company: Haleon
Location: Richmond
Posted on: July 3, 2024

Job Description:

Hello. We're Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we're improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Advil, Voltaren, Theraflu, and Centrum - through a unique combination of deep human understanding and trusted science. What's more, we're achieving it in a company that we're in control of. In an environment that we're co-creating. And a culture that's uniquely ours. Care to join us. It isn't a question.The purpose of this role is to execute CMC regulatory activities for new products registrations and life-cycle maintenance (including variations and annual notifications) for a defined portfolio of products.This role will provide YOU the opportunity to lead key activities to progress YOUR career. - These responsibilities include some of the following:

  • Responsible for CMC regulatory matters relating to registrations and/or life-cycle maintenance of business activities (including variations and annual notifications) for assigned product portfolio.
  • Preparation of CMC sections of new registration files, briefing books, clinical trials applications/INDs, CMC variations, responses to Regulatory Agency technical questions.
  • Interacts with colleagues in other global functions (e.g. Category, BU, Quality and Supply Chain) to deliver high quality CMC sections for dossiers including documents & materials to local Regulatory Affairs in accordance with business priorities. Ensures close partnership with authors, assuring technical congruency and regulatory compliance.
  • Applies processes and procedures to maintain up-to-date technical product records/information and support adequate controls.
  • Provides Regulatory Strategies and CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of appropriate internal compliance records (change controls).
  • Effectively communicates regulatory technical requirements and guidelines, facilitating timely and complete submissions. Develops up-to-date knowledge regarding technical guidelines and regulatory requirements, as well as technical trends.Why you?Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
    • Bachelor's degree in Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering
    • 5 or more years of experience in Regulatory Affairs CMC with knowledge in quality, product development and manufacturing
    • Solid understanding of the US/FDA regulatory requirements and expectations, criteria for submission and approvals and experience with regulatory authority interactions
    • Ability to interpret regulatory guidance and provide regulatory strategies
    • Strong interpersonal and leadership skillsPreferred Qualifications:If you have the following characteristics, it would be a plus:
      • RAC, Masters (MBA, MS, MA), or PhD/PharmD/JD QPHaleon 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. - Care to join us. Find out what life at Haleon is really like At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.Haleon is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.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 Haleon's compliance to all federal and state US Transparency requirements.

Keywords: Haleon, Richmond , Regulatory Affairs CMC Manager (US and Canada), Executive , Richmond, Virginia

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