Robert B. Email and Phone Number

Individual Contributor within GRA-CMC responsible for the preparation of chemical and pharmaceutical manufacturing and control (CMC) content for new market applications and maintenance of CMC documentation for worldwide registration including 'rest of world's markets. Requires continual correspondence and interaction with regulatory agencies, company country subsidiaries, internal project teams and other scientists to support either new or in-line product filings worldwide. Develops CMC strategy for IND/CTA, worldwide marketing application, and filing post approval changes and responding to agency or subsidiary questions. Maintain working knowledge of current governmental and worldwide requirements for clinical studies, initial registration, re-registration and post-approval changes. Assures that filed information on the current manufacturing and testing procedures is kept updated for each product using appropriate departmental systems. Ensures consistency in practices, leverages best practices and operational excellence.

Manage day to day CMC regulatory strategy and submission activities collaborating with domestic and international team members to ensure effective strategy, planning and coordination of complete, high quality documents for submission to regulatory agencies. Assess and clearly communicate regulatory risks to stakeholders and provide actionable mitigation strategies. Determine filing strategy, content, and timelines of CMC sections for regulatory submissions in eCTD format, including, but not limited to BB-IND, BLA, Annual Report, Information Amendments, IR Responses, and Briefing Documents. Assessment of change control impact on US regulatory files. Author, review and submit communications to the FDA.Manage interactions with FDA regarding CMC technical/non-clinical regulatory submission information as an Authorized Agent for Pandemic Flu, Neisseria, Hib, and DTaP pediatric vaccine commercial and development products to provide support to the Global Regulatory Lead assuring efficient communication with the US regulatory authorities to achieve on-time approvals.

Acting as the Regulatory-CMC Manager served as the CMC representative, primary author, and point of contact on regulatory submission project teams. Collaborate with Adolor’s internal and external CMC partners (domestic and international) to determine filing strategy and content of CMC sections for regulatory submissions. Develop timelines for the authoring, editing, and formatting of CMC sections of FDA submissions. Manage post-approval filing strategies and change controls. Author, edit and format CMC sections of regulatory submissions in paper/hybrid and eCTD format for final publishing hand off.Acting as the Analytical & Quality Manager of the Technical Operations Department provided cGMP analytical support for the development and commercialization of Adolor products. Manage contract vendors and analytical laboratories that test all Adolor products to ensure the accuracy, integrity and quality of data. Manage reference standard programs. Develop and manage all API and drug product stability protocols and projects to ensure compliance with IND / NDA Regulatory commitments. Provide technical input and management of analytical issues relating to Adolor partnerships, including the Quality Control review of batch release and stability data, technical and validation reports generated by third party contractors. Prepare data for regulatory submissions, including review of data prepared by third party laboratories. Manage annual product reviews and data trending of Adolor’s commercial products. Participated in internal and external GMP and GLP audits.

Conducted audits of activities and critical documents supporting product launch (method validation, process validation, stability reports, etc.) for compliance to applicable regulatory standards (cGMPs, GLPs, and ICH guidelines).

Managed client CMC strategies by assisting in determining appropriate technical path, developing, and communicating regulatory strategies to provide CMC information to the appropriate regulatory agencies. Prepared and authored CTD formatted CMC sections of INDs and other regulatory CMC documents for client.

Working under a consultant sub-contract to Cephalon, provided strategic and operational regulatory support to product development, manufacturing, and quality assurance for clinical and marketed products. Coordinated and managed all necessary documentation for regulatory submissions to support the CMC section of electronic and hybrid submissions (IND, NDA, Annual Reports, CBE, PAS, and DMF) following CTD format.

Contingent contract worker. Authored cold chain shipping study report covering over 70 configurations to maintain 2-8°C over a 48 hour duration in various environmental conditions.

Managed CMC projects using knowledge of current FDA and ICH Guidelines to determine the scope, content and format of regulatory CMC related documents by authoring submissions in paper and electronic format. Acted as Analytical and Pharmaceutical Science liaison in reviewing batch records, methods, validation and transfer reports, and other documentation for regulatory compliance.

Managed project and support functions for both API and finished dosages while successfully validating new manufacturing processes in preparation for planned solid dose product launch. Acted as analytical and technical liaison between ViroPharma and its third party manufacturers. Managed analytical method transfers to CMOs.

Analytical Industrialization Department: method development, improvement, validation and transfer; technical transfers; semi solid dosages, liquids, parenteral, aerosol products (inhalation and nasal), new product development support; technical support to world wide manufacturing sites.

Temporary contract employee.