Manager, Regulatory Operations
- Watertown, MA, USA
Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary AMPPLIFY TM mucus-penetrating particle (MPP) Drug Delivery Technology, with an initial focus on the treatment of eye diseases. Kala has applied the AMPPLIFY Drug Delivery Technology to a corticosteroid, loteprednol etabonate (LE), designed for ocular applications, resulting in recently approved INVELTY TM for the treatment of inflammation and pain following ocular surgery and its lead product candidate, KPI-121 0.25%, for the temporary relief of the signs and symptoms of dry eye disease, for which a New Drug Application (NDA) has been filed with the United States Food and Drug Administration (FDA) and a target action date under the Prescription Drug User Fee Act (PDUFA) has been set for August 15, 2019.
This position will partner closely with the Manufacturing, Quality, and Clinical teams to ensure timely submission of regulatory documents for developmental programs and commercial products. This role will be responsible for ensuring Regulatory submissions are of the highest quality, delivered on-time, and within established budget. Come join an experienced and growing team!
Key Responsibilities for this role will include:
- Manage electronic submission publishing activities with third-party vendors
- Oversee the management of Regulatory records and databases
- Create and manage submission plans in conjunction with Regulatory colleagues
- Manage response to agency requests for information for applications under review
- Responsible for coordination of lifecycle management for approved NDAs (supplements, annual reports, etc.)
- B.A./B.S. in the sciences, or health related field with 5 years of Regulatory experience
- Have a track record of successful submissions with the regulatory agencies, and the ability to contribute to the submission of global regulatory applications
- Understanding of FDA requirements with respect to content and format for NDA, safety reporting, and promotional submissions
- Ability to work independently with little supervision
- Strong understanding of the drug development process
- Knowledge of global regulatory submission standards and publishing best practices helpful
- Experience communicating with regulatory agencies a plus
- Excellent organizational and project management skills and ability to think strategically
- Outstanding presentation, written and oral communication skills required
Kala Pharmaceuticals is an Equal Opportunity Employer that offers a competitive and comprehensive employee benefits packagetion will be kept confidential according to EEO guidelines.