This position is in the Regulatory CMC group and is focused on the development of biologics. Responsibilities include actively contributing to the development and implementation of CMC regulatory strategy for specific projects including identifying and assessing regulatory risks, serving as the regulatory representative on project teams, serving as the regulatory contact with relevant regulatory authorities,and coordinating all CMC aspects of regulatory submissions.

Qualifications:
- The Ideal candidate will have a minimum of 7 years regulatory working on biologic programs or relevant industry
experience. Additionally, the candidate will/have:
- Demonstrate excellent communication and influencing skills internally and externally at all levels of the
organization.
- Demonstrate effective cross functional and cross cultural skills including influence at external industry meetings.
- Demonstrate strategic thinking, change agent leadership and risk assessment, including ability to integrate
overall business objectives into the goals/vision/values of department and communicate these effectively.
- Ability to work both independently with minimal direction and within project teams, committees, etc. to attain
group goals.
- Ability to represent the department in project teams.
- Demonstrate strong organizational skills, including the ability to prioritize workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical,
scientific, and manufacturing staff.
- Experience in interfacing with relevant regulatory authorities.
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or
supplements.
- Knowledge and understanding of applicable regulations.
- Computer literate.

About Biogen Idec: Transforming Discovery into Care

With operations across the Americas, Europe, and Asia, Biogen Idec (NASDAQ:BIIB) is one of the world's leading biotechnology companies, creating new standards of care in oncology, neurology, and immunology. Every day, employees of Biogen Idec make a difference in people's lives, through pioneering research and development, manufacturing, and our worldwide commercial capabilities.

Learn more at www.biogenidec.com/careers.

Biogen Idec is proud to be an equal opportunity employer

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