Company summary: A rapidly growing clinical-stage biopharmaceutical company is making strides in drug development, thus expanding their pipeline here in the Bay Area!
The organization is small-to-mid sized with no plans of slowing down! This could be a fine time to jump into an organization as a pioneer rather than "just another employee" The regulatory team itself is very collaborative and you will work closely with your director and other teams, bringing a cross-functional aspect to your work. Additionally, there are many benefits to keep employees happy across all functions!
This role is partially on-site with flexibility of remote as well. (ie. 2 times on-site, 3 times off site)
RESPONSIBILITIES:
In this role you will be responsible for:
- Be responsible for and compile submissions for regulatory agencies
- Collaboration with relevant heath authorities (ie. INDs, CTAs) for both clinical and non-clinical documents
- Coordinating appropriate submission activities with the FDA
- Regulatory assessments
- Support some level of QC activities
- Other relevant regulatory/compliance duties
REQUIREMENTS:
The client requires that all candidates have:
- At least a BA/B.S. degree
- At least 2-4 years of experience within biotech/pharma
- At Least 2+ years within Regulatory Affairs
- For Candidates with 5+ years, we still encourage them to apply as this role can be at the Manager level as well.
- An understanding of submissions within RA
- Experience with the FDA regulations
- Strong communication skills
- Drive and Motivation!
