Regulatory Compliance Associate

About USDMUSDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what set us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally. As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more.

From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany. Nature and Scope of JobCommunicate and facilitate regulatory compliance-related priorities and strategies to leadership teams. Coordinate the tracking, preparation, and completion of all facility registrations/licensure (local, state, federal, and foreign).

Ensure regulatory filing support is provided to clientele and maintain compliance in a regulated facility environment. Research regulations and interpret for application of situations related to client information. Primary Responsibilities The following is a list of minimum responsibilities related to the Regulatory Compliance Associate position. Other duties may also be assigned. Review and stay current with local, Federal, and state regulations and publications regarding drug and/or device products. Maintain database and/or tracking systems for local, state, federal, and foreign registrations and licensure for all company facilities (US and EU).

Maintain all company compliance databases (FDA, DEA) to ensure accurate and current agency information. Support the Annual Product Quality Review (APQR) report program for all products packaged at company facilities and review final reports as required. Review client product filing/submission inquiries (foreign or domestic) for relevancy to business activity and facility locations (US or EU). Provide accurate responses associated with product licensing, manufacturing authorizations, and local regulations. Plan/schedule, prepare, and issue compliance-related documents/statements to external customers (e. g.

, Federal and State Registration Certificates, GMP Statements, Debarment Letters, Apostilles/legalization coordination, obtaining required legal signatures for foreign application submissions, and Establishment Inspection Reports). Liaise with the Legal department as appropriate. Responsible for the safe keeping and integrity of the Company Seal used in compliance-related documents/statements, including client product applications (foreign & local). Ensure confidential information (Personnel, Business/Ownership) shared externally is appropriately distributed in a legitimate/legal manner. Assist with initiating and maintaining Drug Listings in the FDA Drug Listing database system at the client’s request.

Coordinate with Quality, Operations, Engineering, Warehousing, Project Management, and Sales teams to address FDA/DEA compliance activities across sites, and ensure compliance with applicable regulations. Assist with FDA and DEA regulatory inspections as needed. Support DEA-related activities including ARCOS Reporting, UN Reporting, Year-End Reports, DEA Form 222, Procurement Quotas, Import/Export, Internal Batch Tracking/Accountability, and Destruction Coordination. Responsible for training designated peers at management request. Complies with company procedures and policies. Decisions and directions provided, if not accurate, could affect company compliance and client engagement.

Additional Responsibilities Performs other related duties and assignments as required Qualifications 5+ years related experience in the pharmaceutical or related industry required Regulatory Affairs experience is a plus Certification in basic quality skills and practices (e. g.

, ASQ, CQIA, CQI, CQT) is a plus Excellent documentation, communication, organizational, and planning skills Knowledge of FDA regulations related to cGMPs and general DEA regulations Ability to multi-task High attention to detail, especially in documentation and compliance Strong written/oral communication and interpersonal skills Outgoing, assertive, reliable, self-motivated, and independent Education & Certifications Associate or Bachelor’s degree preferred Working ConditionsThe working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive.

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job. Unless reasonable accommodations can be made, while performing this job the staff member shall: Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment. Operate other office productivity machinery, such as a calculator, scanner, or printer. Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations. Equal Opportunity StatementUSDM Life Sciences is an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. DisclaimerThis job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. CompensationSalary/Hourly Rate Range (W2): USD 50. 00 - 75.

00The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget. Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off. All employees are eligible for USDM's rewards and recognition program. For more details about our benefits, visit us here: https: //usdm. com/careers