I. Position Summary:
Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, serving as the regulatory representative on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.

II. Duties and Responsibilities:
- Responsible for actively contributing to the development and implementation of regulatory strategy for assigned
projects and programs.
- Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
- Identify and assess regulatory risks for assigned projects or programs.
- Prepare and deliver effective presentations for external and internal audiences.
- Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
- Participate and contribute in Health Authority meetings.
- Represent regulatory on relevant project teams.
- Mentor other Regulatory staff members.
- Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in
all stages of development (pre-IND/IMPD through commercial).
- Contribute to life-cycle management of products.
- Ability to work both independently with minimal direction and within project teams, committees, etc. to attain
group goals.
- Represent the department in project teams.

Qualifications:
- Demonstrate excellent communication and influencing skills internally and externally at all levels of the organization.
- Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical,
scientific, and manufacturing staff.
- 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.
- 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.
- Experience in interpretation of regulations, guidelines, policy statements, etc.
- Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects
of the project.
- Good knowledge of GCPs and GLPs.

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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