Biogen · 11 hours ago
Clinical Trial Application Lead, Biogen West Coast Hub
San Francisco, CA
Full-time
Hybrid
Mid, Senior Level
$118K/yr - $158K/yr
5+ years expBiogen is a mid-sized biotechnology company committed to excellence and innovation. They are seeking a Regulatory Manager to support clinical trial application activities across global studies, ensuring timely and compliant study startup and maintenance in collaboration with CROs and internal stakeholders.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
Coordinate and implement study start up activities in collaboration with CROs and internal study teams
Assist in identifying country-specific regulatory requirements to facilitate timely CTA approvals
Participate in Study Management Team (SMT) meetings to provide regulatory guidance throughout the clinical trial lifecycle
Review and prepare submission packages for Regulatory Authorities for completeness and accuracy
Lead query management and the finalization and submission of responses to competent authorities
Track and coordinate responses to Regulatory and deficiency letters with subject matter experts
Monitor and report on CTA status and updates and study startup progress across assigned projects
Maintain internal regulatory files and ensure documentation is complete and accessible, compliant with ICH-GCP, local regulations and internal processes
Support Audits and inspections related to clinical trial applications
Qualification
Required
Bachelor's degree in life sciences or related field required
5+ years of experience in clinical trial startup and regulatory affairs within the pharmaceutical or biotech industry
Experience with compiling and reviewing regulatory submissions, particularly in accordance with the requirements of EU CTR
Familiarity with CRO operations and global regulatory requirements for clinical trial applications
Strong organizational skills with the ability to manage multiple priorities and meet deadlines
Preferred
Advanced degree
Effective communication and interpersonal skills; ability to work collaboratively across teams
Capable of strategic thinking and risk assessment related to clinical trials
Proficient in project management and documentation systems
Benefits
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
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