Director, Regulatory Affairs
Ra Pharma is a clinical stage biopharmaceutical company that combines expertise in complement biology with proven leadership in peptide chemistry to transform the lives of patients with serious and life-threatening disorders. Ra’s proprietary peptide chemistry discovery engine identifies drug candidates that combine the diversity and specificity of antibodies with the favorable pharmacological properties of small molecules. Our primary clinical focus is on rare diseases associated with complement dysregulation.
Description: Ra Pharma is seeking an experienced and energetic person to be the global and/or US regulatory lead for Ra’s zilucoplan (RA101495 SC) program. The Director, working with the project team and regional regulatory leads in the EU, and other countries, will develop global regulatory strategies, provide regulatory guidance, critically review documents for submission to regulatory authorities, and oversee the execution of the global regulatory strategy by the regions defined by the project team’s goals for each of the indications. The Associate Director will represent Regulatory Affairs on cross-functional project teams, will provide strategic input to the project team, and will lead the regulatory subteam.
RESPONSIBILITIES: Lead all regulatory activities for assigned projects in line with ICH requirements, regional requirements, and company policies and procedures. Contribute to the development of global clinical and regulatory plans and strategies, identify and propose risk mitigation strategies, and influence project teams and sub teams. Prepare and/or manage submissions that are technically complex and require extensive interaction with departments outside of Regulatory Affairs. Develop and implement regulatory strategies and of manage complex negotiations with regulatory authorities. Plan, author, and critically review complex technical documents, and influence colleagues across functions. Lead teams in preparation of submissions. Maintain knowledge of highly complex regulatory requirements, contribute to preparation of new regulatory guidance wherever possible, comment on draft regulatory guidance, and communicate changes in regulatory information to project teams and senior management.
QUALIFICATIONS: The ideal candidate should have a minimum of 8 – 10 years overall regulatory experience in the pharmaceutical industry, with a minimum of 5 years of direct experience as a global lead, and at least one major application (NDA/BLA/MAA/JNDA, etc.). Extensive knowledge and understanding of medical and scientific subject matter and past experience with direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA) is required. Experience in rare diseases is highly desirable. The candidate must have a BA/BS degree or equivalent in a health science field. The candidate must have excellent knowledge of applicable U.S. and international regulations and guidelines. Excellent oral and written communication slills are a must as are superior planning skills. The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
To apply: Email resume to email@example.com
We provide a highly stimulating working environment coupled with a high level of intellectual challenge. We offer a very competitive salary and benefits program. Ra Pharmaceuticals, Inc. is an equal opportunity employer committed to embracing and leveraging diverse backgrounds. M/F/D/V