Regulatory Affairs Coordinator (Rancho Cordova, CA)

LHH is teaming up with an established client search of a Regulatory Affairs Coordinator!

The Regulatory Affairs Coordinator will ensure the organization complies with federal and state regulations by securing and maintaining necessary licenses.

They will support certification processes, review customer licenses, liaise with regulatory agencies, manage adverse event reporting, and handle product recalls.

The ideal candidate is a detail-oriented and ethical professional with a bachelor’s degree in business or a related field and 3-5 years of experience in regulatory and compliance roles.

They possess strong analytical, research, and problem-solving skills, along with excellent written and verbal communication abilities.

Proficiency in MS Outlook, Word, and Excel, as well as the ability to collaborate effectively across departments and interact confidently with regulatory agencies, is essential.

Familiarity with FDA regulations and experience with wholesale distributor licensing or other regulatory areas are highly beneficial.

Key Responsibilities :

Daily Operations :

Monitor compliance-related communications.

Coordinate with Customer Care team to resolve account queries.

Verify prescription authorization accuracy for new customer accounts.

Update Medical Director records and renew medical licenses, including DEA and Prescription Authorization Forms.

Prepare and submit applications and renewals for facility pharmacy and Board Designated Representative licenses.

Conduct monthly audits of facility and customer licenses for regulatory compliance.

Collaborate with department managers on annual updates to policies and procedures related to medical devices and pharmaceuticals.

Document employee training on company policies and procedures.

Periodically update the FDA Wholesale Distributor License Reporting portal with current license data.

Support product recall procedures as necessary.

Conduct visual compliance inspections within the facility.

Act as the primary contact for regulatory agency interactions.

Respond to regulatory inquiries, including subpoenas.

Represent the organization during audits and inspections.

Interpret and apply FDA and other regulatory standards to business operations, providing guidance to the organization.

Collect and handle confidential corporate and individual information for licensing purposes.

Monitor regulatory updates and identify changes impacting the business, recommending compliance protocol enhancements.

Required Knowledge, Skills, and Abilities :

Eagerness to learn FDA regulations.

Strong ethical standards and confidentiality.

Ability to collaborate across departments.

Excellent analytical, research, and problem-solving skills.

Superior written and verbal communication skills.

High attention to detail and accuracy.

Effective task organization and prioritization.

Strong interpersonal skills and conflict resolution abilities.

Proficiency in MS Outlook, Word, and Excel.

Ability to define problems, collect data, and draw valid conclusions.

Goal-oriented and results-driven.

Team-oriented mindset and commitment to organizational success.

Education, Licenses, and Experience :

Bachelor’s degree in business or a related field.

Eligibility to obtain a CA Pharmacy Board Designated Representative License.

3-5 years of administrative experience in regulatory and compliance roles.

Experience with wholesale distributor licensing or other regulatory areas is advantageous.

Familiarity with medical device and pharmaceutical regulations is beneficial.

Experience interacting with regulatory bodies like FDA, VAWD, and State Boards of Pharmacy is preferred.

Job Type : Temp-to-Hire

Location : Fully on-site in Rancho Cordova, CA

Pay Rate : $35-$45 / hour, depending on experience

Hours : Full time, regular office hours

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan.

Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law;

any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.

If you have the qualifications above and are interested in this opportunity please apply today! If you are curious what else is available, please review the LHH website!

Pay Details : $ to $ per hour

Search managed by : Emily Sclar

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan.

Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs.

In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.