Regulatory Affairs Associate
Associate/Senior Associate, Regulatory Affairs
Location: San Carlos, CA (Hybrid options available)
Industry: Clinical-stage Biopharmaceuticals
A leading clinical-stage biopharmaceutical company is seeking a talented Associate or Senior Associate in Regulatory Affairs to join their growing team. This organization is focused on developing innovative therapeutic antibodies for cancer, autoimmune, and other serious diseases, and offers an exciting opportunity to contribute to impactful drug development programs.
About the Opportunity
You will play a key role in supporting global regulatory submissions and communications with health authorities, managing regulatory archives, coordinating with external eCTD publishing teams, and ensuring the smooth operation of day-to-day regulatory activities.
Key Responsibilities
- Collaborate with cross-functional teams to finalize high-quality, compliant regulatory submissions (eCTD format)
- Prepare and support routine submissions to health authorities under supervision
- Serve as regulatory document and submission support for assigned projects
- Coordinate with the Regulatory eCTD publishing team for document publishing and archival
- Manage regulatory submission trackers, archives, and commitment trackers
- Work with Quality and other departments to ensure data accuracy and integrity for submissions
Qualifications
- Bachelor's degree in a scientific field (advanced degree a plus)
- Minimum 2 years' experience in Regulatory Affairs within biotechnology/biopharmaceuticals
- Experience supporting regulatory submissions (INDs in the US, CTAs in Europe, Australia, Asia)
- Familiarity with ICH, CFR, and global health authority requirements
- Strong organizational and submission management skills
- Proficiency with Microsoft Office, Adobe, and eCTD software
- Excellent interpersonal skills and ability to work collaboratively
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your CV and details on file so when we see similar roles or see skillsets that drive growth in organisations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your CV so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customised support on how to optimise your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.