Lipocine, 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.
Lipocine's clinical development pipeline encompasses a variety of programs at various stages, from Phase 1 through NDA submission. Lipocine’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
Lipocine's corporate office is based in scenic Salt Lake City, Utah, which is near a variety of internationally recognized summer and winter parks and recreation areas. In national surveys, Salt Lake City generally rates in the top 10 locations to live.
Lipocine offers excellent growth opportunities and a competitive benefits package commensurate with expertise. This is an on-site position (no remote), at our Salt Lake City headquarters. Please email your CV to email@example.com, or fax to (801) 994-7388. Lipocine is an equal opportunity employer.
Lipocine Inc. is a biopharmaceutical company focused on neuroendocrine and metabolic disorders using its proprietary drug delivery technologies. Lipocine's clinical development pipeline includes: LPCN 1148, LPCN 1144, LPCN 1111, LPCN 1107 and oral neuroactive steroids including LPCN 1154 and LPCN 2101. TLANDO, a novel oral prodrug of testosterone containing testosterone undecanoate, is approved by the FDA for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism, in adult males. LPCN 1148 is an oral prodrug of bioidentical testosterone targeted for the management of symptoms associated with liver cirrhosis. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a Phase 2 clinical study demonstrating potential utility in the treatment of non-cirrhotic NASH. LPCN 1111, a novel oral prodrug of testosterone, originated and is being developed by Lipocine as a next-generation oral testosterone product with potential for once-daily dosing. In a phase 2 clinical evaluation when administered as once or twice daily, LPCN 1111 met primary and secondary endpoints. LPCN 1107 is potentially the first oral hydroxyprogesterone caproa...te product candidate indicated for the prevention of recurrent preterm birth and has been granted orphan drug designation by the FDA. Neuroactive steroids are currently being evaluated including LPCN 1154 for the potential treatment of postpartum depression and LPCN 2101 for the potential treatment of epilepsy. For more information, please visit www.lipocine.com.