Nivagen Pharmaceuticals Inc

DEA Manager

Sacramento, CA 95834

Sponsorship not specifiedDetected 106 days ago

ComplianceAccessibilityAuditingSupply ChainProcurementGMPFDA RegulatoryCommunication

About the role

Play a critical role in the day-to-day activities of the DEA Compliance program as it relates to Title 21 CFR, Part 1300-End and the Drug Enforcement Administration (DEA), as well as ensure compliance with all federal and state regulations.
Creation and revision of procedures to ensure correct documentation, traceability, and accountability as it relates to DEA-controlled substances and SC-DPH activities to minimize the risk of diversion.
Preparation and submission of periodic reports to the DEA (ARCOS, CSOS, YERS, and Quota Procurement Requests, etc.).

Support day-to-day tasks to maintain DEA Federal and State controlled substance compliance across multiple sites and to identify and achieve departmental strategies and objectives.
Lead Regulatory Inspections by DEA and SC-DHP.
Maintain an understanding of and abide by all cGMPs, compliance, regulatory, and quality requirements.

The physical requirements and working conditions listed for this job are representative of those required on the job.
Continuously required to stand, sit, walk, talk, and hear, frequently required to stand, sit, walk, talk, and hear, occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl.
The essential duties and responsibilities listed below are representative of those required on the job.
Liaison for the DEA, SC-DPH, and other state and local agencies as required.
Participate in other Regulatory Inspections (FDA) as required to support.
Maintain and adhere to departmental budget, as required.
Perform other related duties as required or assigned.
To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily.

Bachelor's degree in a scientific field.
10+ years of related work experience in the pharmaceutical industry, with an emphasis on regulatory reporting preferred, specifically DEA experience.

Previous work experience in the pharmaceutical industry with an emphasis on DEA compliance, or relevant experience in a related field.
Knowledge of and ability to apply cGMP and DEA regulations as they relate to liquid pharmaceutical manufacturing.
Strong oral and written communication skills.
Advanced organizational skills.
Microsoft Suite software is required.
Ability to function well in a high-paced and at times stressful environment.
Detail-oriented.

Coordinate and over-sight of reconciliation audits of controlled substance inventories for all DEA Registrations (Annual, Biennial, Year-End, etc.)

Benefits: Medical, Dental, and Vision coverage
Paid time off plan
Computer keyboarding, computer monitor, and mouse, including reaching forward, grasping, finger and wrist manipulations, and neck bending and turning; near vision is necessary for computer monitor use.

to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
Nivagen Pharmaceuticals Inc., Sacramento, CA
3900 Duckhorn Dr, Sacramento, CA 95834
Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market.
For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people.
Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.
Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability.
We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities.
By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry.
At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.
Equal Opportunity Employer.

This listing is sourced directly from Nivagen Pharmaceuticals Inc's careers page and normalized into a canonical job model.