Senior Manager, US Regulatory Affairs

Job Description

About this Role:

As the Senior Manager US Regulatory Affairs, you will work closely with the US Regulatory Lead (USRL). You 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 may assume responsibilities as an acting USRL with supervision from the Director/Senior Director. You also will provide support for product labeling and conduct regulatory due diligence for topics of interest/relevance. In collaboration with the USRL, you will lead submissions such as US products labeling, Structured Product Labeling (SPL), FDA Information Requests, and Annual Reports. You may support other global submission activities as appropriate in collaboration with the USRL and Global Regulatory Lead

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:

· Must have direct US regulatory strategy experience.

· BS in a in Life Science or related discipline required.

· 2-4 years of experience in Regulatory Affairs (Strategy).

Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.