Director CMC Regulatory Affairs

Primary Duties: Under the direction of the Sr. Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing and executing CMC strategies across product life cycles. Mange submissions and interactions with the FDA and other regulatory agencies for CMC issues. Provide regulatory support, guidance and expertise to internal groups such as product development, jQA, QC and manufacturing teams to ensure that all applicable regulatory requirements are considered and appropriately incorporated into development programs and that products are developed and manufactured in compliance with appropriate regulations and guidelines so that they be studied and marketed as planned. Coordinate or oversee preparation of regulatory documentation in a timely manner to meet corporate objectives Responsibilities: 25% - Develop CMC regulatory strategy and manage regulatory activities and timelines for one or more investigational and marketed products 25% - Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies 25% - Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations 25% - Provide CMC regulatory guidance to project / product teams. Education and Experience Requirements: M.S. / Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field. Minimum of 7 years experience in pharmaceutical product development with 4-5 years in leadership of CMC regulatory affairs with a strong biologics background. Significant experience in directing interactions with regulatory authorities. Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product develo ment and maintenance. Key Skills and Competencies: Ability to manage complex projects, timelines and teams in a matrix team environment. Excellent analytical and communication skills - both verbal and written. Ability to communicate effectively to multiple levels of the organization with strong negotiation skills. Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
Shire is an Equal Opportunity and Affirmative Action Employer