Senior Associate, Regulatory Affairs (2008044)

Founded in 2003, Acceleron Pharma, Inc. is a biopharmaceutical company developing therapeutics for musculoskeletal, metabolic and cancer-related diseases. In the complex and rapidly evolving field of drug discovery and development, the depth of the team and the way the team members work together are two of the most critical success factors.We have a unique culture, team, and approach that is rapidly translating our ideas and assets into drugs that will make a significant differencein patients' lives.Acceleron has raised over $85M in venture financing including $31M from our Series C financing in October 2007. We have assembled a strong management and scientific team comprised of established leaders with significant biotechnology and pharmaceutical industry experience. We are seeking talented and passionate individuals who thrive in a dynamic, `fast-paced, team-oriented and collaborative environment to be part of our success.DescriptionAssist in planning, reviewing, and preparing regulatory submissions to support clinical trials and product approvals. Provide regulatory advice on non-clinical/clinical strategies, and provide solutions to drug development challenges that ensure compliance with global regulations. Participate on project teams to represent the functional area. Reports to the Director (or Vice President) of Regulatory Affairs.Required Skills

• Oversee the preparation, review and submission of investigational new drug applications (INDs), IND information amendments, annual reports and corresponding global submissions
• Assist with development of effective regulatory strategies for global product development, and effectively communicate to development team
• Communicate with regulatory authorities (FDA, EMEA, HPFB, etc.), as directed
• Develop and maintain/manage timelines for the preparation of submissions
• Be knowledgeable of key global guidance documents, regulations, or directives and effectively communicate any impact on Acceleron’s development programs
• Contribute to development plans supporting global product approvals
• Maintain www.clinicaltrials.gov database for Acceleron’s development productsRequired Experience

BA/BS, preferably in a scientific discipline with approximately 5 years regulatory experience.
Knowledge of eCTD content/format requirements and proficiency with MS Project.
Experience working in a team in environment, ability to work on multiple projects simultaneously, and excellent organizational, verbal and written communication skills are essential.Submitting a resume online at a job site could cause valuable screening information to be missed.

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Acceleron Pharma is an Equal Opportunity Employer