As the Sr. Manager Global Regulatory Affairs, you will work closely with the Global Regulatory Lead (GRL) and 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 may assume responsibilities as an acting GRL with supervision from Director/Senior Director. You also will provide support for the global product labeling framework and conduct regulatory due diligence for topics of interest/relevance. Additionally, you will work with the regional regulatory teams to ensure global alignment along with meeting regional specific needs and interface with the regulatory operation team.
What You'll Do:
- Must have direct US or EU regulatory strategy experience.
- 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.
- Demonstrate solid oral communication and writing skills.
- Ability to represent the department in project teams.
- Develop collaborative relationships to facilitate the accomplishment of work goals.
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.
- BS in a in Life Science or related discipline required. Advanced degree preferred.
- 6 years of experience in Regulatory Affairs (Strategy).
All your information will be kept confidential according to EEO guidelines.
Biogen Inc. is an American multinational biotechnology company based in Cambridge, Massachusetts, specializing in the discovery, development, and delivery of therapies for the treatment of neurological diseases to patients worldwide.