Salt Lake City, UT
The company, an emerging leader in research and development of innovative products to treat metabolic and endocrine disorders, is seeking a self-motivated individual wanting to make an impact on a variety of therapeutic areas while growing professionally with the company.
The company's clinical development pipeline encompasses a variety of programs at various stages, from Phase 1 through NDA submission. The company’s pipeline includes therapeutics for men’s and women’s health including prevention of preterm birth, testosterone replacement therapy, postpartum depression, non-alcoholic steatohepatitis (NASH), and liver cirrhosis.
Responsible for the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures that pre-clinical and clinical trial designs meet regulatory requirements. Provides advice to development on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
- Keep abreast of current regulatory requirements and provide regulatory advice
- Work on INDs, NDAs, CTAs, BLAs and MAAs in different regions around the world, including nonclinical, and clinical activities
- Develop and implement regulatory strategies to facilitate the progress of programs in all phases of development
- Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing direction, solutions and feedback to the teams
- Lead interactions with regulatory agencies for projects and products including liaising and negotiating with FDA, EMA and other HAs interactions, including appropriate documentation of the interaction, decisions and outcomes with oversight from supervisor
- Independently lead the preparation and timely submission of regulatory filings, maintain existing products up to regulatory standards and plan for life cycle management
- Provide regulatory affairs representation on project teams; lead regulatory sub-teams. Act as single point of RA contact on cross-functional teams; foster a global view as a member of the development team.
- Works closely with all departments to coordinate all activities required to develop the product including clinical supplies on time and on budget.
Education and Experience
- Advanced degree in a scientific discipline (e.g., Masters, Pharm.D., M.D., Ph.D.)
- Experience in the pharmaceutical industry (at least two years), including regulatory interactions with FDA preferred
- Deep and broad knowledge of regulatory affairs strategy; direct experience with pharmaceutical regulatory submissions and product approvals in the US. EU and global experience preferred.
- A proven track record of effective collaboration with regulatory agencies, including the FDA
- Experience with and line extensions strategy for marketed products preferred
- Excellent verbal and written communication skills
- Evaluative, analytical and interpretative skills enabling review and synthesis of reports and other documents used in regulatory planning and submissions
- Ability to work with minimal supervision, to set priorities to meet timelines, to motivate others, and to manage budgets
- Creative problem solving and strategizing abilities