Lisa Freeman Email & Phone Number

Washington Dc-Baltimore Area

Boston, Ma, Us

Boston, Ma, Us

Rockville, Maryland, Us

Novato, California, Us

Gaithersburg, Maryland, Us

• Global regulatory strategy lead on cross-functional product development teams for investigational monoclonal antibodies for autoimmune and neurology indications including orphan diseases • Primary regulatory interface with health authorities and strategic partners; led face-to-face meetings with FDA, Health Canada, PMDA; managed strategy for IND (eCTD) and CTA submissions, amendments, US and EU orphan applications, SPA, EMA Scientific Advice • Responsible for presentation of regulatory precedence, strategy and risk assessments to senior management and leading Regulatory sub-teams in support of product development teams

Gaithersburg, Maryland, Us

• Global regulatory strategy lead on cross-functional product development teams for investigational monoclonal antibodies for autoimmune and oncology indications including orphan diseases• Managed regulatory compliance (clinical, non-clinical, CMC) and life cycle strategy for oncology drug marketed in 65 countries; interfaced directly with US, EU and Canadian regulatory authorities and global marketing partners; key projects included: multiple CMC supplements/variations, support of major manufacturing facility renovation; license renewals in EU and RoW; annual PSURs; outlicense of EU authorizations to 3rd party;• Managed up to 3 direct reports in preparation and delivery of routine regulatory submissions

Gaithersburg, Maryland, Us

• Managed review and preparation of CMC sections in CTD-format marketing applications to EU and US• Managed preparation, review and submission of US electronic IND applications for investigational vaccine, including pre-clinical, clinical and CMC information. • Supported QA group by providing regulatory oversight of GMP documentation including change controls, SOPs, batch records

Brentford, Middlesex, Gb

• Managed US post-approval CMC regulatory projects for biologics and small molecule anti-infective and antiviral products, including development of regulatory strategies, regulatory risk assessments, submission and follow-up of supplemental applications, review of product Annual Reports and distribution reports, and submission of Biological Product Deviation Reports• Served as principal interface with FDA reviewers to resolve regulatory issues and secure submission approvals, and with CBER Product Release Branch to secure timely batch releases and continuity of supply• Provided on-site regulatory support for FDA (CBER) inspection of foreign sterile manufacturing facility and interfaced directly with investigators to address regulatory issues• Developed key partnerships with foreign manufacturing site counterparts and improved communication between groups regarding regulatory issues; assessed manufacturing site change control documents for regulatory impact and communicated regulatory requirements to internal customers

Brentford, Middlesex, Gb

Brentford, Middlesex, Gb

Master Of Science (M.S.), Chemistry

Bachelor Of Science (B.S.), Chemistry