This position is in the Regulatory CMC group and is focused on the development of large molecules (biologics), including both commercial and development programs. 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:
Ideal candidate will have a minimum of 8 years strategic regulatory leadership and planning experience working on large molecule (biologics) programs, including 4 years people management experience.

Key Requirements:

Communication Skills:
- Demonstrate excellent communication and influencing skills internally and externally and in particular the ability to
impact and influence decisions on global teams.
- Strong interpersonal skills and the ability to deal effectively with a variety of business areas including medical,
scientific, and manufacturing staff.

Leadership Skills:
- Demonstrate effective cross functional and cross cultural skills including ability to impact industry/agency organization
decisions.
- 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 and
demonstrate optimism and energy in the face of change and adversity.
- 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.

Management Skills:
- Demonstrate experience in managing/supervising a small team, ability to assess and provide strategic guidance and
impact organizational effectiveness including across cross functional teams.
- Demonstrate skills and experience in hiring, performance management, capability building, coaching and
mentoring with peers and subordinates and budget responsibilities.
- Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.

Regulatory Skills:
- 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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