Company Summary: Our client is one of the Bay Area's most exciting and innovative Biotechs in the Hepatology space. Following an incredibly eventful 2019 which included tremendously successful IPO as well as some outstanding data read-outs of their Phase 2 and 3 trials, this company is setting itself up for an even
more amazing 2020. As the company enters the home stretch for their first novel filing, targeted by the end of 2020 they are looking to add a key hire in their
already world-class regulatory affairs team. Truly amazing chance for someone looking to advance their career opportunities.
Responsibilities:
-You will work with product leads and provide regulatory documentation, as needed, and adhere to guidance and legal obligations.
-You will interact with Regulatory, Clinical Operations, and other teams to ensure efficient execution of regulatory strategy and development of drugs.
-You will represent the Regulatory Affairs at cross functional submissions as well as study management team meetings.
-You will collaborate with medical and technical writers to manage and submit product prioritization designation requests.
-You will team up with medical and technical writers to ensure proper document preparation timelines and communicate expectations with team members to allow
timely reviews, achieve milestones, and document deliverables.
Qualifications:
-Degree in biological, life sciences, pharmacology, medicine, or related fields. Equivalent international degrees also considered.
-Advanced degree with a minimum of 10 years of experience in the pharmaceutical industry and a minimum of 6 years in Regulatory Affairs is preferred.
-Experience representing Regulatory Affairs on cross functional teams is preferred.
-Ability to multi-task while maintaining excellent organizational and planning skills.
-Great verbal and written communication skills.
Work Environment:
-This is a high-growth and fast-paced organization.
- You will have the chance to travel internationally and domestically.
If interested apply now!
