Manager, Global Regulatory Affairs, HI-Bio

HI-Bio, Inc. is a Biogen company based in South San Francisco, California. As of July 2, 2024, we are part of Biogen’s global team, with a commitment to excellence and a pioneering spirit. As part of a mid-sized biotechnology company, we offer 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. 

Our team in San Francisco is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey. 

About this Role:

HI-Bio, Inc., a Biogen company, is seeking a Manager, Global Regulatory Affairs to work closely with the Global Regulatory Lead (GRL) for a given program(s). You will be asked to participate on cross-functional project teams on an agenda-driven basis along with providing support for the GRL as needed. You will support development of US label and work collaboratively with the team to ensure implementation of the US label, which includes providing guidance regarding US labeling precedence to the cross functional teams. You will be responsible for interfacing with Regulatory Operations and CROs to support various submissions to Health Authorities, in support of investigational applications, clinical trial applications, and/or marketing authorizations.  Additionally, you will support the GRL and cross functional teams on major submissions related to initial Investigational New Drug (IND) and/or New Drug Application (NDA)/Biologics Licensing Application (BLA) submissions, and supplemental applications, as needed.

What You’ll Do:

• You must exhibit excellent operational competences, including planning, organizing and other project management skills.
• You demonstrate solid oral and written communication skills.
• You can independently build networks with cross-functional team members to support collaboration and generate innovative solutions by identifying novel approaches to address work challenges and opportunities.
• You have knowledge and understanding of applicable regulations, including experience in interpretation of regulations, guidelines, and policy statements.

Who You Are:

In addition to having exceptional relationship building, you successfully worked in a matrix environment where you collaborated with other teams within the organization. You generate innovative solutions in work situations and build on your networks to obtain cooperation without relying on authority.

This position is preferred to sit as a hybrid role in South San Francisco, CA, however the hiring team is open to US-remote talent.

• Combination of the following can be considered: PhD or PharmD with 2+ years of pharmaceutical industry experience in regulatory affairs; MS with 4+ years; BS with 5+ years
• Knowledge and understanding of applicable regulations and experience in interpretation of regulations, guidelines, and policy statements
• Excellent operational skills including planning, organizing and ability to represent the department in project teams
• Ability to work independently with minimal direction and to work well within cross-functional teams
• Solid oral communication and writing skills
• Develops collaborative relationships to facilitate the accomplishment of work goals
• Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
• Can build networks to obtain cooperation without relying on authority

The base compensation range for this role is $100,000 - $162,000. Base salary is determined by a combination of factors including, but not limited to, job related years of relevant experience, internal equity, and location of the job. Additionally, this role is eligible for participation in Biogen’s LTI grants and other incentive programs. Biogen offers a full range of benefits that include medical, dental, life, long and short-term disability insurances, vacation, end-of-year shutdown, and 401K participation and matching contributions. 

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.