Hiring.Camp

Regulatory Affairs Associate Specialist

The Future of Health Starts with You

·

Yesterday

Salary
$26 – $43
Location
Irving, TX, USA - 6555 North State Highway 161 (P001), United States of America
Workplace
Hybrid
Type
Full-time
Department
Legal
Seniority
Entry
Source
Workday

Description

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care.

What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.

We are seeking a Regulatory Affairs Associate Specialist. This role is a hybrid in the Dallas-Fort Worth Metropolitan area. If the applicant is located outside of the area, they must be willing to relocate.

As a Central Support Team member, this role’s primary responsibility is to support McKesson’s Controlled Substances Monitoring Program (CSMP). The duties for this position include, but are not limited to, providing administrative support to the Regulatory Affairs Department; supporting the Manager of Central Support in the processing of regulatory documentation; conducting initial customer due diligence; and using tools, reports, and data in accordance with CSMP policies and procedures. In addition, this position supports projects ranging in size, complexity, and effort that directly impact the CSMP. This will require collaboration with internal partners, regulatory affairs team members, and customers.

Key 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.

Minimum Requirement

Typically, minimum 0-2 years of relevant experience. May have degree or equivalent.

Critical Skills

  • 2+ years of controlled substance regulatory compliance experience.

  • 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.

Additional Skills

  • Adaptable to changing environment/technology.

  • Result orientated and assertive attitude.

  • Team building qualities.

  • Mature confidence and integrity.

  • Degree preferred.

Physical Requirements

  • Traditional office requirements.  A large percentage of time performing computer-based work is required.

  • Less than 10% travel or as needed

This role is a hybrid position. The selected candidate is expected to work on-site at our Las Colinas office a minimum of two (2) days per week, with the remaining days worked remotely. Specific in-office days may be designated based on team needs and business priorities.

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. 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. For more information regarding benefits at McKesson, please click here.

Our Base Pay Range for this position

$26.12 - $43.54

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. In light of these scams, please bear the following in mind:

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


McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.

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

McKesson is an Equal Opportunity Employer

 

McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

 

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) [email protected] or (Canada) [email protected]. Resumes or CVs submitted to this email box will not be accepted.

Join us at McKesson!

Skills

ExcelComplianceProject Management

Similar Jobs

30

Regulatory Affairs Associate

"OBAGI COSMECEUTICALS, LLC" · Long Beach, CA

1 week ago

Regulatory Affairs Associate

Gsknch · GSK Asia House, Singapore

1 week ago

Regulatory Affairs Associate

Heluna Health · San Francisco, CA

2 weeks ago

Associate, Regulatory Affairs

ClinChoice · Yerevan, Armenia

1 month ago

Regulatory Affairs Associate

EKF Diagnostics Inc · Boerne, TX

1 month ago

Regulatory Affairs Associate

Epic Pharma · Laurelton, NY

1+ year ago

Senior Associate Regulatory Affairs

Amgen is committed to unlocking · Egypt - Cairo · Hybrid

Yesterday

Regulatory Affairs Associate II

INBIOS INTERNATIONAL INC · Seattle, WA · Hybrid, Onsite

6 days ago

Local Regulatory Affairs Associate - Pharmaceutical Registration in Azerbaijan

Lifted · Baku, Azerbaijan · Remote

6 days ago

Regulatory Affairs Associate - Pharmaceutical Registration

Lifted · Samarkand, Samarqand Region, Uzbekistan · Remote

6 days ago

Regulatory Affairs Associate - Pharmaceutical Registration

Lifted · Namangan, Namangan Region, Uzbekistan · Remote

6 days ago

Regulatory Affairs Associate - Pharmaceutical Registration

Lifted · Andijan, Andijan region, Uzbekistan · Remote

6 days ago

Regulatory Affairs Associate - Pharmaceutical Registration

Lifted · Tashkent, Uzbekistan · Remote

6 days ago

EAEU Regulatory Affairs Associate

Gsknch · Almaty, Kazakhstan

1 week ago

Regulatory Affairs Associate - Clinical Trials submissions (Mexico)

Parexel · Mexico-Remote · Remote

1 week ago

Senior Associate, Regulatory Affairs

ICU Med · Lake Forest, IL, United States, US · Hybrid

1 week ago

Quality - Regulatory Affairs Associate

"Englewood Lab, Inc." · Totowa, NJ · Onsite

1 week ago

Regulatory Affairs Associate – Respiratory and Immunology

AstraZeneca is · Poland - Warsaw · Hybrid

2 weeks ago

Regulatory Affairs Associate – Respiratory and Immunology

AstraZeneca · Warsaw, Masovian Voivodeship,PL, PL · Hybrid

2 weeks ago

Senior Regulatory Affairs Associate - CMC biologics/vaccines (home or office based)

Parexel · Poland-Remote +8 · Remote

2 weeks ago

Senior Associate, Regulatory Affairs CMC

Iovancebiotherapeutics · Remote · Remote

2 weeks ago

Regulatory Affairs Associate - Full Time - Germantown, TN

Westcancercenter · Germantown, TN +1

3 weeks ago

Regulatory Affairs Associate Publishing

Parexel · Mexico-Remote · Remote

3 weeks ago

Senior Regulatory Affairs Associate

Solventum · AU, New South Wales, North Ryde, Australia · Hybrid

3 weeks ago

Senior Associate Regulatory Affairs Strategy

Alcon · Fribourg, Switzerland

4 weeks ago

Senior Regulatory Affairs Associate

Parexel · India-Bengaluru-Remote · Remote

1 month ago

Senior Associate, Regulatory Affairs (Hybrid)

ICU Med · Lake Forest, IL, United States, US · Hybrid

1 month ago

Staff Regulatory Affairs Associate (Digital Health & AI Technologies)

Whoop · Boston, MA · Onsite

1 month ago

Germany_Senior Associate Regulatory Affairs (m/f/d)

Celltrionhealthcare · Germany

1 month ago

Senior Regulatory Affairs Associate- Clinical Trial Application

Parexel · India-Bengaluru-Remote · Remote

1 month ago
Regulatory Affairs Associate Specialist at The Future of Health Starts with You • $26 – $43 | Hiring.Camp