Regulatory Affairs Sr. Associate
The Sr. Associate, Regulatory Affairs position supports the Regulatory Manager as part of the QA/RA Department by maintaining product compliance.
Key Responsibilities- The core elements of Controlled Substance Monitoring Program (CSMP) Include:
- Conducting/Maintaining due-diligence and reviewing SAP, forms, and processes
- Reviewing prospective Customers and determining whether a prospective Customer may be approved to receive controlled substances distributed by RxC
- Reviewing Customers on an ongoing basis and, as appropriate, determining when a customer is no longer approved to receive controlled substances distributed by RxC
- Establishing and maintaining order thresholds for approved Customers that limit the monthly quantity of controlled substances for each base code that Customers may order
- Monitoring Customer’s orders for controlled substances to identify orders of interest in accordance with certain specified criteria
- Investigating each order of interest and documenting RxC’s determination as to the disposition of the order, including whether to release or block the order
- Reporting to DEA and relevant state regulatory authority’s orders blocked under the CSMP as suspicious orders
- Maintaining Import/Export documents
- Ensuring FDA Readiness documents are complete and accurate
- Product Verification
- Ensuring DSCSA adherence and compliance
- Coordinates and conducts the assessment of internal controls to ensure compliance as required by regulatory commissions/authorities
- Manages complaint cases brought to regulatory authorities and process improvements to avoid future complaints
- Advances organization positions with internal and external parties
- Prepares and sponsors testimony to governmental or regulatory agencies
- Documents internal regulatory processes, such as internal audits, inspections, license renewals, or registrations
- Prepare materials for submission to regulatory agencies
- Conduct employee regulatory training
- Interprets regulatory rules or rule changes and ensure that they are communicated
- Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents
- Tracks quality regulatory metrics
- Participates in internal or external audits
- Maintains technical files as necessary to obtain and sustain product approval
- Any other duties as assigned.
Minimum Requirements:
- High School degree or equivalent
- 2+ years of relevant experience
Business Experience:
- Knowledge of all regulatory aspects of business
- Ability to communicate both verbally and via documentation
- Highly Motivated
- Detail Oriented
- Excellent Problem-Solving Skills
- Strong Work Ethic/Dependability
- Professional in behavior and appearance
- Be able to work independently or with a cross team effort
- Analytical mind
- Computer knowledge, fluent in Microsoft Office and Excel but able to learn other programs easily Specialized Knowledge/Skills
- Familiarity with CFRs, cGMPs and GDPs
- Action Oriented
- Drive for Results
- Adaptability
- Technology adaptive
- Strong writing skills
- Ability to lead intradepartmental groups and multiple teams
Working Conditions:
- Traditional office environment.
- Warehouse
- Travel: Less than 10%
Physical Requirements:
- Large percent of time performing computer-based work is required
At CoverMyMeds, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at CoverMyMeds, please click here.
As part of Total Rewards, we are proud to offer a competitive compensation package at CoverMyMeds. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.
Our Base Pay Range for this position
$57,900 - $96,500
CoverMyMeds is an equal opportunity and affirmative action employer. We embrace diversity and are committed to creating an inclusive environment for all employees. Qualified applicants will be considered for employment without regard to race, religion, gender, gender identity, sexual orientation, national origin, age, disability or veteran status.