About this role
About This Role:
As the Regulatory Manager, Clinical Trial Application (CTA) Lead, you will play a key role in supporting the planning and execution of clinical trial application activities across global studies.
You will collaborate closely with Clinical Research Organizations (CROs) and internal stakeholders such as study management teams to ensure timely and compliant study startup and maintenance. You must have experience with clinical trial applications, particularly in the EU to be successful in this role.
The Regulatory Manager will report to the Head of Clinical Trials Application, within Biogen’s Global Regulatory Affairs organization. This is a hybrid role based in the SF Bay Area. As part of Biogen’s WCH, this role will support high-priority clinical programs in Biogen’s immunology portfolio.
What You will Do:
- 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.
Who You Are:
You are a proactive and detailed-oriented individual who thrives in a dynamic environment. Your commitment to patient outcome drives your ability to manage clinical trial applications with finesse and ensure accurate submissions and smooth approvals. Your ability to coordinate regulatory documents for submissions showcases your organizational adaptability. You approach challenges with a collaborative mindset and constantly seek ways to enhance processes.
Required Skills:
- 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 Skills:
- 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.
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- 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
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Other facts
About Biogen
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities.
We apply deep understanding of human biology and leverage different modalities, to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
With approximately 7,000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Baar, Switzerland and we have world-class manufacturing facilities in North Carolina and Solothurn, Switzerland. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
For more information, please visit www.biogen.com. Community Guidelines: https://www.biogen.com/community-guidelines.html
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What you'll do
- Coordinate and implement study startup activities in collaboration with CROs and internal study teams. Review and prepare submission packages for Regulatory Authorities for completeness and accuracy.
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