About the Job
Manager, Regulatory Affairs(RAF 2017)
Ra Pharmaceuticals, Inc. (NASDAQ: RARX), is a clinical stage biotechnology company focused on development of novel therapeutics for the treatment of serious diseases that are caused by excessive or uncontrolled activation of the complement system, a critical component of the immune system. Ra Pharma combines its expertise in area of complement with leadership in macrocycle peptide technology to discover and develop therapeutics that transform the lives of patients with life threatening disorders.
Description: Ra Pharma is seeking an experienced and energeticpersonto manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. The Sr. Specialist/Manager will represent Regulatory Affairs on cross-functional project teams, will provide inputto the project team,will lead authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive.
- With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC.
- Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
- Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad.
- Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents.
- Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and provide expertise on regulatory matters.
- Develop and maintain current regulatory knowledge and advise management of significant developments. Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO’s as required.
Qualifications:The ideal candidate should have a minimum of 5years overall regulatory experience in the pharmaceutical industry. The candidate must have a BA/BS degree or equivalent in a health science field. Experience and knowledge in preparation of INDs and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical). Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working knowledge of FDA and ICH regulatory guidance and regulations. Understanding of FDA structure and function. Knowledge/experience with regulatory requirements for other regions also desirable. Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle. Excellent oral and written communicationslills 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.
Salary and title commensurate with experience. Please submit cover letter and resume to email@example.com