Director of Regulatory Affairs
About the Company:
Surface Ophthalmics is a pharmaceutical company focused on development and commercialization of innovative therapeutics for ocular diseases. Our current drug pipeline, all of which use a patented delivery vehicle, consists of three proprietary drug candidates for the treatment of: i) mild to moderate dry eye disease (DED), ii) acute DED, and iii) pain and inflammation for patients recovering from ocular surgical procedures. Together our product candidates address a multibillion-dollar market in the U.S and around the world. We are a start-up company with a small, closely-knit team. As we grow our programs and operational complexity, we are adding key positions to support our business.
Surface is headquartered in Pleasanton, California and offers a hybrid office & home work environment for most positions. The people at Surface are a dedicated, fun, and caring group to work with. We value initiative, collaboration, transparency, integrity and a drive for achieving our common objectives.
About the Opportunity:
Surface Ophthalmics is seeking an experienced regulatory affairs professional to lead our Regulatory department. This individual will interface with other Surface team members to provide overall submission and project strategy, general regulatory guidance, and help and/or prepare IND/NDA documents. The incumbent will be an integral reviewer of project and submission-related documents across all disciplines, and will work with and foster a successful working relationship with FDA personnel.
- Hands-on position within an ultra-small pharmaceutical company: strategizing, writing, and reviewing all regulatory documents to support INDs and NDAs.
- Provide ongoing regulatory support to Clinical, Nonclinical, CMC and Quality to address regulatory issues and questions.
- Provide technical review of protocols, reports, and other development-related documents across all development areas (i.e., clinical, nonclinical and quality) to assure scientific rigor, accuracy, and clarity of presentation.
- Author and manage the development of high-quality regulatory documents and submissions that may include, but not be limited to INDs, NDAs, submission amendments, meeting requests, DSURs, IBs, briefing documents/meeting packages, and general regulatory correspondence with health authorities.
- Coordinate and oversee regulatory contractors, as needed, and other future regulatory staff.
- Liaison with eCTD publisher and submit documents for publication and review published output.
- 10-15 years demonstrated experience in regulatory drug development and experience with FDA interactions, including key milestone meetings, Pre-IND, End-of-Phase 2, Pre-NDA.
- Prior regulatory or clinical ophthalmic experience and experience with 505(b)(2) applications desirable.
- Demonstrated ability to think strategically and critically and evaluate risks to regulatory activities.
- Excellent oral and written communication skills.
- Knowledge of GCP, GMP and GLP regulations, as well as ICH and FDA guidelines.
- Proficient with MS Word with experience in document formatting.
What’s in it for you:
Our employees enjoy benefits that make them more productive and contribute directly to the development of their professional skills. We want to be able to attract the best of the best and make sure they keep getting better. On top of an exciting and intellectually challenging workplace, we are offering:
- Work in a highly dynamic industry with a company focused on innovative science
- A hybrid home/office work schedule
- Collegial and supportive colleagues in a fun environment where personal development and success are high priorities
- Competitive medical / dental / vision packages
- 401K with company match
Surface is an equal opportunity employer. We want applicants of diverse backgrounds and hire without regard to race, color, gender, religion, national origin, ancestry, disability, age, sexual orientation, or any other characteristic protected by law.
Please send your resume and brief cover letter to: email@example.com.