Sr Compliance Manager

The Senior Compliance Manager plays a pivotal role within the Regulatory Affairs Department, overseeing company-wide regulatory compliance activities. This includes managing private label product development, licensing, cGMP compliance, inspection readiness, and quality oversight of labeling and packaging processes. The role provides strategic regulatory insight, leads audit preparedness, and manages high-impact investigations and projects related to product compliance and regulatory filings. Essential Duties & Responsibilities Lead company readiness and response for FDA, DEA, and State Board audits. Oversee licensing, product registration (SPL), and regulatory reporting obligations. Manage compliance investigations, documentation, and resolution of quality issues. Approve and oversee cGMP-compliant batch records, SOPs, and packaging specifications. Drive process improvements and risk mitigation in compliance operations. Serve as a liaison to external regulatory bodies and compliance partners. Mentor and train Regulatory Affairs staff on evolving standards and practices. Analyze trends in compliance activities and prepare executive reports. Participate in cross-functional meetings with R&D, Quality, Legal, and Supply Chain. Represent the department in strategic initiatives and executive briefings. Required Qualifications Bachelor's degree in Life Sciences, Regulatory Affairs, or related field; advanced degree preferred. Minimum 5-7 years of compliance or regulatory experience in pharmaceutical manufacturing. Expert knowledge of FDA, DEA, and cGMP regulations. Strong leadership and communication skills. Proven experience managing audits and regulatory inspections. High proficiency in Microsoft Office and regulatory databases (e.g., ARMS, FileMaker). Preferred Qualifications RAC Certification or equivalent regulatory credential. Experience managing SPL submissions and DEA Form 222 documentation. Background in regulatory training and quality system oversight. Physical & Work Requirements Primarily office-based, with occasional lifting (up to 50 lbs.). Ability to sit for extended periods. On-site presence required at Pulaski, TN headquarters.

Benefits:

Competitive salary and bonus structure Comprehensive health, dental, and retirement plans Ongoing professional development opportunities A dynamic and collaborative work environment #WeAreHealthDelivered Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. AvKARE/R&S Northeast is an E-Verify and Equal Opportunity Employer. All qualified applicants will receive considerations for employment without regard to race, color, religion, sex, age, disability, marital status, sexual orientation, genetic information, gender identity, national origin, citizenship status, disabled veteran or veteran of Vietnam era, or any legally recognized status entitled to protection under applicable federal and state local laws. #INDHP1