This position will provide Regulatory Affairs strategic and tactical support for activities relating to the preparation and submissions of NDAs, INDs, ANDAs, amendments, and supplements accordingly. This position will cover both the clinical regulatory, as well as some chemistry, manufacturing and control (CMC) aspects. The incumbent may act as a contact for assigned projects within the company, with outside vendors and consultants, and with the Food and Drug Administration and/or other governmental agencies. The incumbent should be a self-starter, comfortable working on projects with little supervision, however, needs to possess a team attitude with the ability to brainstorm ideas/strategies.
The incumbent will ensure that regulatory projects are aligned with department priorities and submission timelines. Working in conjunction with internal business partners and management, the incumbent will support the development and execution of regulatory strategies, provide tactical support for a variety of submissions, assist in the generation of IND, NDA, and ANDA applications, amendments and supplements. Provide regulatory input regarding change control filing mode and submission content requirements.
Osmotica Pharmaceutical is a global specialty pharmaceutical company with a proven history of developing commercially successful pharmaceutical products using a proprietary osmotic technology platform. In February 2016, Osmotica Pharmaceutical combined with Vertical Pharmaceuticals, LLC and Trigen Laboratories, LLC to create a world-class, fully-integrated specialty pharmaceutical and generics company.
Vertical Pharmaceuticals, LLC was founded in 2003 with a mission to develop, market, and acquire products offering therapeutic benefits for patients and healthcare providers. Vertical Pharmaceuticals supplies branded prescription products, specializing in Neuroscience and Women’s Health with brands such as Lorzone®, Divigel®, and OB Complete®.
Trigen Laboratories, LLC is a generic pharmaceutical company offering unique products across an increasing array of categories. Trigen seeks to bring value-driven generic products to its customers, working vigorously with its partners to identify and develop products which face an assortment of challenges. Additionally, Trigen identifies unique marketing opportunities and is steadfast in its pursuit to deliver products to best serve these markets.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability or veteran status.