Associate Director, Regulatory Affairs, CMC-Small Molecule

Biogen Idec uses cutting edge science to discover, develop, manufacture and market biological medicine for the treatment of serious diseases with high unmet need. We are the world's oldest independent biotechnology company and a Fortune 500 company with more than $4 billion in revenues and offices located worldwide.

We are the trusted source of vital therapies for multiple sclerosis, such as AVONEX and TYSABRI. We also discovered RITUXAN, the world's most prescribed treatment for non-Hodgkin's lymphoma and an effective treatment for rheumatoid arthritis. Patients worldwide benefit from our products, and count on us not only for their medication, but also for a variety of support programs.

In addition to our global leadership in the treatment of MS, we have leveraged our R&D and commercial expertise to pursue life-saving and life-changing therapies for other neurodegerative diseases, including ALS (Lou Gehrigs disease), Alzheimers and Parkinsons diseases. We are continuing to advance our high potential programs in hemophilia and build on our scientific strength in immunobiology.

Our culture of excellence empowers employees to challenge conventional wisdom and propose better ways of doing thing; bringing additional value to all of our stakeholders, starting with the people we come to work for everyday - the patients, our families and ourselves.

This position is in the Regulatory CMC group and is focused on the development of small molecules, specifically, early and late stage programs. Responsibilities include actively contributing to the development and implementation of CMC regulatory strategy for specific small molecule projects including identifying and assessing regulatory risks, implementing NDA/MAA filing readiness strategy, developing pre-NDA/MAA agency meeting strategies, 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.
Ideal candidate will have a minimum of 8 years strategic regulatory leadership and planning experience working on small molecule programs.

Key Requirements:

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

Leadership Skills:
oDemonstrate effective cross functional and cross cultural skills including ability to impact industry/agency organization decisions.
oDemonstrate 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.
oAbility to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
oAbility to represent the department in project teams.

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

Regulatory Skills:
oExperience in interfacing with relevant regulatory authorities.
oExperience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
oKnowledge and understanding of applicable regulations.
oComputer literate.