Regulatory Affairs and Compliance Head - Atrium
Woodbridge, NJ
About the Job
Our client, a Pharmaceutical Manufacturing and Distribution company. They are seeking a Regulatory Affairs and Compliance Head to join their team!
Salary/Hourly Rate:
$150,000
Position Overview:
The Regulatory Affairs and Compliance Head will oversee Compliance Department’s activities. The Regulatory Affairs and Compliance Head duties will include managing Standard Operating Procedures (SOPs) for distributing generic pharmaceuticals and controlled substances to U.S. customers. They will frequently interact with the CEO, CFO, Warehouse Manager, Vendors/Clients, Sales Team, Customer Service Representatives, and Compliance Team members.
Responsibilities of the Regulatory Affairs and Compliance Head:
- Oversee operations within the Compliance, Quality and Warehouse Department
- Manage Standard Operating Procedures for distributing generic pharmaceuticals and controlled substances nationwide
- Collaborate with the CEO, CFO, Warehouse Manager, Vendors/Clients, Sales Team, Customer Service Representatives, and Compliance Team
- Establish and supervise external customer accounts
- Ensure accurate completion of DEA documentation for scheduled substances
- Develop and enforce security protocols for processing, warehousing, and distribution of Scheduled Drug Substances
- Maintain up-to-date knowledge of DEA Schedules and policies
- Prepare SOPs for 100% control of Scheduled Drug Substances operations
- Manage annual and monthly material plans for quota management
- Conduct capacity analysis for the manufacture, storage, and shipment of scheduled drugs
- Train staff on regulatory policies and procedures
- Investigate and report on non-compliance incidents
Qualifications for the Regulatory Affairs and Compliance Head:
- Previous experience in a generic pharmaceutical compliance role
- Familiarity with drug development, FDA and DEA regulations, and guidance documents
- Solid understanding of business, legal, and regulatory practices
- Excellent oral and written communication skills
- Strong problem-solving and decision-making abilities
- High level of organizational and computer skills
- Detail-oriented with the ability to meet deadlines and perform under pressure
- Willingness to travel as needed
Education Requirements:
- Bachelor’s degree in a related field, such as Pharmacy, Pharmaceutical Sciences, or a related regulatory discipline is required
Benefits:
- Competitive and comprehensive benefits package offered
As a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.
EOE/M/F/D/V/SO
Position ID: 152146
Source : Atrium
