Nature and Scope
The incumbent will be responsible for collaborating with key stakeholders to ensure that product development goals established by life cycle management committee are executed in a timely manner for the company. The incumbent will be involved in planning and be directing product development activities of selected compounds and successful launch of approved products. In teaming up with RA Director, the incumbent will ensure that the Company is meeting all requirements from a regulatory perspective including licensure, submissions, promotional materials, and reports. This includes FDA, and all international, federal, state and local agencies as appropriate.
Essential Duties and Responsibilities
- Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- Provide scientific and technical leadership for the development of New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and New Animal Drug Applications (NADAs).
- As a core leader of the New Product Development Team, assign appropriate development teams and timelines and provide direction to development activities from development phase through product launch
- Provide management, leadership, and oversight for product lifecycle management. Ensure that all developmental activities from formulation development, method development, process scale-up and technology transfer, exhibit (registration) batch manufacture, FDA submission to commercial product launch are executed in an expedient manner.
- Recruit, mentor and lead a high-performance team to develop complex generic parenteral products. Establish organizational infrastructure, processes, and methodologies to drive efficiencies and innovation and achieve superior performance with a commitment to continuous improvement.
- Work closely with Regulatory Affairs Management to ensure all pertinent regulatory documentation such as PDR/ CMC documentation are prepared for timely submission of NDA/ ANDA/ NADA/505(b)(2)s. Attend FDA Teleconferences/ meetings when needed.
- Provide Clinical R&D with pertinent clinical study material and CMC support for clinical study and regulatory filing respectively.It's to provide oversight to make clinical batches to help the clinical group to conduct clinical trials and help with CMC sections of Investigational New Drug Applications.
- Provide detailed R&D monthly updates.
- Embrace the Quality culture and demonstrate Core Competencies. Develop and improve procedures to ensure compliance with cGMP testing methods and equipment.
- Perform any other tasks/duties as assigned by management.
- We all must embrace the QUALITY culture.
Qualifications and Requirements
- Ph.D. in the life sciences with a concentration in Chemistry or Pharmaceutical Science required.
- Minimum 5 years of demonstrated leadership experience managing drug development programs and staff.
- Minimum 8 years relevant industry experience in formulation, analytical and process development with solutions, lyophilized and/or suspension dosage forms.
- Excellent organizational, leadership and interpersonal skills required. Strong communication skills and technical writing skills are essential.
- Experience managing multiple projects simultaneously and prior supervisory and/or management experience required.
- Demonstrated application of current CMC regulatory requirements and FDA guidance.
- Working knowledge of regulatory process and requirements.