Associate Director, Regulatory Affairs (Labeling and Advertising/Promotion)
Dova is a clinical-stage pharmaceutical company developing treatments for patients suffering from orphan diseases. The company’s lead investigational compound, avatrombopag, is in the process of completing two pivotal Phase 3 clinical trials researching its use as a potential treatment for thrombocytopenia in patients with chronic liver disease undergoing an elective procedure. For more information on the company visit www.dova.com.
Responsibilities will include, but are not limited to, the following:
- Provide regulatory guidance to cross-functional teams that establish strategy and vision for promotional materials, sales training materials, and other external communications.
- Responsible for coordinating all aspects of regulatory submissions of promotional materials relevant to assigned projects and programs.
- Responsible for accuracy and content of communications with FDA
- Actively contribute to the development and implementation of regulatory strategy for promotional materials as well as any other assigned projects and programs.
- Regulatory point of contact for promotional review committee
- Manage updates to FDA approved labeling (e.g. US Prescribing Information), and ensure all updates are appropriately reflected in promotional materials.
- Decision maker in review meetings
- Ability to influence teams
- Work is performed under general direction. Capable of strategic thinking and risk assessment for area of responsibility. Demonstrate good communication skills (oral/written/listening).
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances.
- Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
- Bachelor’s degree in scientific discipline; advanced scientific degree preferred.
- A minimum of 7 years pharmaceutical industry with a minimum of 5 years in regulatory affairs, including direct regulatory promotional and non-promotional material review experience. Experience leading and managing updates to prescribing information (PLR format) is highly desirable. Global experience desirable.
- Extensive knowledge of advertising and promotion regulations and ability to interpret regulations to promotional materials and non-promotional materials
- Extensive knowledge of FDA regulations and guidance on content and format of product labeling is highly desirable.
- Thorough knowledge of the drug development process, with a focus on IND and NDA processes.
- Demonstrated experience in preparing new IND and/or NDA submissions.
- Results driven and team-orientated with the ability to influence outcomes as necessary skills in the environment.
- Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze and solve problems with minimal supervision and exceptionally keen skills for attention to detail.
- Occasional domestic and international travel may be necessary
To apply please send CV and letter of interest to email@example.com