Manager- Regulatory Affairs CMC
The Manager CMC Global Regulatory Affairs will direct and manage CMC regulatory strategy of one or more biological and/or small molecule products. This will include formulating and implementing CMC regulatory strategies for the development of protein therapies and CMC regulatory activities for assigned projects in line with US or ICH requirements. Primary role includes:
* Provide collaborative support for execution of global strategies to other regions (EU & International).
* Manage submissions and interactions with the FDA and Health Canada for CMC issues.
* Provide support to other HA interactions as required
* 30%:Develop global CMC regulatory strategy and manage regulatory activities and timelines for one or more investigational and marketed products
* 30%:Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies
* 10%:Collaborate with EU & International regulatory colleagues in development of global CMC regulatory strategies
* 10%:Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines
* 10%:Provide CMC regulatory guidance to project / product teams
* 10%: Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Education & Experience Requirements:
* B.A. / B.S./ M.S. / Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field
* Minimum of 8 years' experience in pharmaceutical product development including significant experience in CMC regulatory affairs with a strong biologics background or equivalent.
* Experience in directing interactions with regulatory authorities desired.
* Knowledgeable in ICH and FDA guidelines relevant to CMC aspects of product development 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
* Ability to communicate effectively to multiple levels of the organization with strong negotiation skills
* Ability to work successfully with cross-functional teams and influence appropriate plans and actions
* Strong attention to detail, establishing priorities, scheduling and meeting deadlines
* Must be able to work in a fast paced environment with demonstrated ability to effectively manage multiple competing tasks and demands
* Ability to work independently, take initiative and complete tasks to deadlines
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.
Application URL: http://www.aplitrak.com/?adid=andoYWxlbi4xOTIyMi4zMTY3QHNoaXJlLmFwbGl0cmFrLmNvbQ