Regulatory Affairs Senior Associate - Full-time / Part-time

Profile & Mission

Cumberland Pharmaceuticals is a specialty pharmaceutical company that acquires, develops and commercializes branded prescription products designed to improve quality of care and address unmet medical needs.

With a focus on underserved niche markets, including hospital acute care and gastroenterology, we deliver products that serve patients in the U.S. market. Cumberland also makes its products available to patients internationally through select strategic partnerships.

While Cumberlands commercial capabilities are focused on the U.S. market, our business development team is actively pursuing opportunities to make our brands available to patients in markets around the globe.

Our primary mission is to improve upon patient care with products that offer clear advantages over existing treatments. We also strive to deliver solutions that may help reduce costs for healthcare providers and, ultimately, patients.

BROAD FUNCTION:

To maintain Clinical & Regulatory submissions to FDA for both pre and post marketed products (Projects).

PRINCIPAL RESPONSIBILITIES:

1. Manage the receipt, maintenance, approval, submission, and distribution of documents including nonclinical and clinical trial master files, adverse drug experiences, product complaints, regulatory submissions/correspondence, batch records and standard operating procedures;
2. Control electronic templates for regulatory, professional affairs and clinical documents and SOPs;
3. Initiate new SOPs, revise existing SOPs and manage SOP review process as required and as they relate to operations departments;
4. Liaise with Professional Affairs and Regulatory departments to ensure compliance with regulatory reporting/submission deadlines;
5. Coordinate publishing activities for all FDA submissions;
6. Review advertising and promotional materials;
7. Coordinate package insert and other labeling for SPL submission;
8. Manage IND and NDA annual reports;
9. Manage PDUFA and NDC activities;
10. Other projects or duties, as assigned.

Requirements

Required: Must be able to handle several projects simultaneously, be detail oriented and extremely organized. Skilled in the use of word processing, spreadsheet, email, and database software. Experienced in drug development strategy. Experienced in eCTD submissions for INDs and NDAs.

Education: Bachelors degree or higher.

Preferable: Pharmaceutical industry experience with focus in regulatory knowledge and medical writing.

Benefits

Cumberland offers a competitive salary and extensive benefits package including medical, dental, vision, life and disability insurance, 401(k), and generous PTO (paid time off).

Cumberland Pharmaceuticals provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Cumberland Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.