The Regulatory Affairs Specialist plays an important role in executing regulatory activities that support compliance across a broad and diverse portfolio of regulated healthcare products within McKesson's Private Label business.
This role ensures alignment with U.S. regulatory requirements through the preparation of submissions, maintenance of labelling and compliance activities, and contribution to pharmacovigilance and quality system processes.
The role holder will collaborate cross-functionally and with external partners to support market readiness, regulatory integrity, and operational excellence across the product lifecycle, The role is performed with limited oversight, requiring strong self-direction and accountability for regulatory deliverables.
The role operates with a high level of autonomy and is expected to manage complex regulatory responsibilities and deliverables with minimal oversight.
KEY RESPONSIBILITIES Regulatory Compliance Perform regulatory compliance activities to meet to US Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), Customs and Border Protection (CBP), and Federal Trade Commission (FTC) requirements, and internal quality standards.Prepare, submit, and maintain regulatory filings, including post-marketing submissions, and product lifecycle registrations listings, in accordance with FDA guidelines.Maintain accurate records of National Drug Codes (NDCs) and Universal Product Codes (UPCs), maintaining version control and data integrity.Perform Country of Origin (COO) determinations and maintain product certifications in McKesson's Trade Agreements Act (TAA) Portal in support of US government contracting activitiesPrepare technical documents to support First DataBank (FDB) registration.Support responses to regulatory inquiries and inspectionsContribute to the development and maintenance of regulatory procedures and work instructions, contributing to continuous improvement of compliance frameworks.Support regulatory impact assessments and ensure documentation complies with QMS standards.Contribute to regulatory strategy development based on evolving regulations.
Labelling Compliance Review and approve product labelling to ensure alignment with regulatory requirements, approved applications (e.g., NDA, ANDA), USP monographs, and internal brand standards.Track the progress of labelling changes and support change control activities across functions, ensuring timely implementation.Collaborate with internal and external partners to ensure labelling accuracy and compliance during new product introductions and lifecycle updates.Assist in system administration of labelling management applications.
Pharmacovigilance experience with data tracking and regulatory dashboards is a plus.
Knowledge of eCTD structure, SPL, and electronic regulatory submission platforms Familiarity with Smartsheet, project management tools, Work Environment: Hybrid work model; ability to work from home and in the general office environment At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people.
That's why we have a Total Rewards package that includes comprehensive benefits to supportphysical, mental, and financial well-being.
Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves.
As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson.
This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets.
The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations.
In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
Our Base Pay Range for this position €49,900 - €83,100 McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson's (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages.
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