Manager, Regulatory Affairs (US) Details

Manager, Regulatory Affairs (US)

Biogen - Cambridge, MA

Employment Type : Full-Time

Job Description

About this Role:

As the Manager US Regulatory Affairs, you will work closely with the US Regulatory Lead (USRL) for a given program(s) and will be asked to participate on cross-functional program and project teams on an agenda driven basis along with providing support for the USRL as needed. You will act as a core member of the US labeling team 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 the Regulatory Operations team to support various submissions to the FDA in support of your programs. Additionally, you will support the USRL and cross functional teams on major submissions related to your programs including initial Investigational New Drug (IND) and/or New Drug Application (NDA)/Biologics Licensing Application (BLA) submissions, supplemental applications, and Responses to Information Requests, as needed.

What You’ll Do:

• You have excellent operational skills including planning, organizing and ability to motivate others.
• The ability to work independently with minimal direction and to work well within cross-functional teams.
• You can demonstrate solid oral communication and writing skills.
• You have the ability to represent the department in project teams.
• You develop collaborative relationships to facilitate the accomplishment of work goals.
• Generate innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
• Build networks to obtain cooperation without relying on authority.
• The knowledge and understanding of applicable regulations.
• Experienced in the interpretation of regulations, guidelines, policy statements.

Who You Are:

In addition to having exceptional relationship building, you can successfully work in a matrix environment where you collaborate 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.

Required Skills:

• BS in a in Life Science or related discipline required.
• 2 years of experience in Regulatory Affairs (Strategy).

All your information will be kept confidential according to EEO guidelines.

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