Regulatory Affairs Associate Specialist jobs in United States
info-icon
This job has closed.
company-logo

McKesson · 1 day ago

Regulatory Affairs Associate Specialist

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. They are seeking a Regulatory Affairs Associate Specialist to support McKesson’s Controlled Substances Monitoring Program, providing administrative support and collaborating with internal partners and customers.

BiopharmaBiotechnologyHealth CareInformation TechnologyPharmaceutical
check
H1B Sponsor Likelynote

Responsibilities

Organize and coordinate incoming regulatory requests, which includes monitoring and ensuring completeness of documentation and creating and maintaining regulatory due diligence files in accordance with CSMP policies and procedures
Participate in due diligence reviews that may include conducting state license and DEA registration checks, open-source checks, and use of customer-specific data
Drafting detailed due diligence reports or other related documents
Frequently interact with Regulatory Affairs team members to support CSMP process
Liaison with customers or McKesson Sales personnel on behalf of the Regulatory Affairs Department to secure additional information as needed

Qualification

Controlled substance complianceRegulatory documentationProject managementMS Office skillsAnalytical skillsMultitaskingCommunication skillsCollaboration skillsWriting skillsAdaptability

Required

Typically, minimum 0-2 years of relevant experience
Experience in controlled substance regulatory compliance
Understanding of project management and process development
Demonstrates the ability to multitask
Demonstrates the ability to succeed in a high-stress environment
Possess strong communication, collaboration, and influencing skills
Strong writing and analytical skills
Possess working knowledge of federal and state government laws and regulations related to controlled substances
Intermediate to advanced MS Office (Word, Outlook, Excel & PowerPoint) skills

Preferred

Degree or equivalent in 2+ years of controlled substance regulatory compliance experience strongly preferred
Degree preferred
Adaptable to changing environment/technology
Result orientated and assertive attitude
Team building qualities
Mature confidence and integrity

Benefits

Competitive compensation package
Annual bonus
Long-term incentive opportunities

Company

McKesson

company-logo
McKesson distributes medical supplies, information technology, and care management products and services.

H1B Sponsorship

McKesson has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (149)
2024 (129)
2023 (82)
2022 (142)
2021 (144)
2020 (154)

Funding

Current Stage
Public Company
Total Funding
unknown
1994-11-18IPO

Leadership Team

leader-logo
Brian Tyler
CEO
linkedin
leader-logo
Jim McAuliffe
CFO
linkedin
Company data provided by crunchbase