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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 activities
- Prepare technical documents to support First DataBank (FDB) registration.
- Support responses to regulatory inquiries and inspections
- Contribute 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 & Risk Management
- Manage the lifecycle of Safety Data Exchange Agreements (SDEAs), including tracking, revisions, and compliance verifications.
- Develop and maintain the pharmacovigilance audit schedule using a risk-based approach
- Coordinate and lead pharmacovigilance audits of suppliers
- Review and approve all safety reports (15-Day Report, Periodic Adverse Drug Event Report) prior to submission to FDA
- Complete adverse event and medical device vigilance assessments

Regulatory Operations & Cross-Functional Collaboration
- Partner with internal stakeholders, suppliers, and external agencies to facilitate smooth product launches.
- Participate in cross-functional meetings and project teams to represent regulatory requirements and timelines.
- Generate and maintain regulatory reports, performance dashboards, and tracking metrics for internal compliance monitoring
- Operate within McKesson’s Quality Management System (QMS) and contribute to process improvements.
- Prepare regulatory reports and performance metrics to track compliance status.
- Contribute to regulatory strategy development, ensuring alignment with business objectives.

The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties.

REQUIREMENTS

Education:

Bachelor’s degree or higher in Chemistry, Microbiology, Pharmaceutical Sciences, or a related field.

Experience:

Minimum 4+ years of regulatory experience in the pharmaceutical or medical device industry.

Key Skills & Competencies:

Strong knowledge in regulatory submissions, compliance strategies, and product lifecycle management.
Analytical and critical thinking skills with the ability to interpret complex data and regulatory guidelines.
Effective written and verbal communication skills with the ability to collaborate cross-functionally and with external partners.
Highly organized with exceptional attention to detail and accuracy in documentation.
High attention to detail with a structured, process-driven approach.
Proactive, adaptable, and able to manage multiple priorities in a fast-paced environment.
Committed to ongoing learning and development within the regulatory affairs discipline.

Technical Proficiency:

Proficient in Regulatory and Quality systems, such as MasterControl, TVT (Text Verification Tool), and Opal BPM
Proficient in Microsoft Office Suite (Excel, Word, PowerPoint, Outlook, Teams); 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 support physical, 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

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McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.

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McKesson job postings are posted on our career site: careers.mckesson.com.

Regulatory Affairs Specialist

Job Description