Senior Manager Regulatory Affairs

Must reside within a commutable distance from our Lakewood, NJ location.

Responsibilities

• Overall responsibility for compiling regulatory submissions to Federal and State agencies, drafting submissions to include client Product Information, CareTria Facility Information, literature searches to support corporate submissions, client and/or government agency notification, and other regulatory activities.
• Manages the renewal and maintenance of CareTria's federal and state distributor licenses for all warehouse locations, including preparation of supporting documents for new and renewal licenses for submission to state licensing agencies.
• Submits requests to Finance for payment of all licenses, permits, and other required regulatory agency filings.
• Maintains Regulatory Affairs (RA) and Quality Assurance (QA) departments expenditure documentation, including reports to Finance.
• Responds to requests and queries; serves as liaison with state regulatory officials in connection with licensing matters under the supervision of the Vice President of Regulatory Affairs and Compliance.
• Stays abreast of regulatory updates and changes in license filings as they affect CareTria's warehouse facilities.
• Manages surety bonding requirements to ensure CareTria maintains compliance with all applicable state licensing agencies.
• Assists in the research and interpretation of state and regulatory regulations/rules related to wholesaler, third-party logistics provider, and business licensing requirements.
• Conducts regulatory research and assists the Compliance Manager and Compliance Analysts with updates to CareTria's mid-level prescriptive authority table.
• Manages updates to CareTria's wholesaler regulation database for warehouse facilities.
• Assists with client audit questionnaires and compilation of responses to audit reports.
• Assists with re-accreditation of CareTria by the National Association of Boards of Pharmacy for all warehouse locations, including annual compliance evaluations for all facilities.
• When necessary, assists the Compliance Training Manager and/or QA with tracking, scheduling, and coordinating internal PDMA and cGMP training.
• When necessary, assists in the coordination of Client Compliance/CIA Training.
• Prepares Knipper and client FDA, DEA, and state submissions for Loss/Theft Reporting and other compliance violations.
• Arranges all appointments and meetings for the Regulatory Affairs and Compliance department using own judgment; resolves telephone requests directly or through appropriate resource.
• Maintains Regulatory Affairs and Compliance files.
• Contacts state boards of pharmacy to facilitate manual adjudication for CareTria prescriber validation program.
• Assists Vice President, Regulatory, Compliance, and QA with projects and follow-up as needed.
• Document archiving as required.

The above duties are meant to be representative of the position and not all-inclusive.

Requirements

• Associate degree plus five years of legal or compliance administrative work experience or comparable years of experience.

Skills

• Knowledge of the pharmaceutical industry, including drug storage and distribution.
• Knowledge of inspection processes for drug sample distribution.
• Strong knowledge of PDMA and DSCSA.
• Experience working on regulatory submissions.
• Excellent written and verbal communication skills.
• Ability to understand and communicate legal risk.
• Proficient in MS Office, Excel, and Word; basic understanding of data processing; ability to learn new business and warehouse management software/systems.
• Excellent organizational and data entry skills.
• Detail-oriented with strong computer knowledge and customer service awareness.
• Notary Public certification.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Pay

The expected base pay range for this position is $90,000–$95,000 per year. Actual compensation may vary based on market differences, skills, experience, qualifications, and location or work schedule.

Benefits

• Comprehensive health, dental, and vision insurance.
• Retirement plan options.
• Paid time off and paid parental leave.
• Employee assistance programs and other perks.
• Eligible employees may access performance bonuses.