Bryan Hill Email & Phone Number

Arlington, Tx, Us

Arlington, Tx, Us

Gaithersburg, Maryland, Us

• Remote position serving as a regulatory affairs leader for the global vaccine and medical countermeasure portfolio (smallpox, anthrax, cholera, Ebola virus, and intravenous (IV) treatments), authoring submissions for the United States, Australia, Singapore, and Canada. Responsibilities include:• Project Lead for submission of an Extraordinary Use New Drug Submission (EUNDS) to Health Canada, for importation of the ACAM20000 smallpox vaccine to the Public Health Agency of Canada (PHAC). Responsibilities included scheduling the Pre-Submission Meeting with Health Canada, assembly of the Briefing Package, creation of the PowerPoint presentation, Pre-Submission Meeting preparation, composing the Meeting Minutes, as well as assembly and submission of the EUNDS application (Modules 1 – 5), with writing emphasis in Module 2 (Quality Overall Summary) and Module 3 (CMC).• Technical writing and submission of a variety of Chemistry, Manufacturing, and Controls (CMC) reports to government health authorities, including responses to Complete Response Letters, Information Requests, and Canadian Clarifax requests, as follows:• Food and Drug Administration (FDA-CBER, US) – Prior Approval Supplement (PAS), Changes Being Effected in 0/30 Days (CBE-0/CBE-30) Supplement, Annual Report, Lot Release Protocol, Lot Distribution Report, Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)• Therapeutic Goods Administration (TGA, Australia) – Category 3 Request, Self-Assessable Request (SAR), Notification Request, Changes That Do Not Require Prior Approval• Health Sciences Authority (HSA, Singapore) – Minor Variation 1 (MIV-1), Minor Variation 2 (MIV-2) Notification, Minor Variation 2 (MIV-2) Do-and-Tell• Health Canada (HC, Canada) – Yearly Biologic Product Report (YBPR)• Provide written regulatory assessments for global Change Controls affecting approved licenses in four different countries, ensuring compliance with government regulations.

Basel, Basel-Stadt, Ch

• On-site Sandoz position at the Alcon-Ft. Worth, TX facility, serving as a regulatory liaison between Sandoz, Alcon, and the Food and Drug Administration (FDA) for the Sandoz ophthalmic/otic commercial and product development generic drug products made at the Alcon-Ft. Worth plant. • Submission of post-approval reports to FDA – Annual Reports, Changes Being Effected in 0/30 Days (CBE-0/CBE-30) Supplements, Prior Approval Supplements (PAS) – for approximately 26 commercial Sandoz products sold in the United States (US).• Management of the FDA drug approval process for approximately 8 unapproved Sandoz Abbreviated New Drug Applications (ANDAs). Responsibilities include writing and submitting eCTD Modules 1-3 to FDA via new submissions and responses to FDA Complete Response Letters and Information Requests.

Grand Prairie, Tx, Us

• Project management assignment reporting directly to the Chairman of the Board of Neos Therapeutics.• Main responsibilities included ensuring successful launch of Tussionex Generic to market (occurring in September 2013), regulatory strategy and project management of all New Drug Application (NDA) submissions scheduled for Food and Drug Administration (FDA) submission in 2014 - 2015, and conducting executive-level meetings.

Grand Prairie, Tx, Us

• Joined the facility formerly known as PharmaFab for the challenge of remediating a company placed under Consent Decree by the US Department of Justice. PharmaFab had been banned from pharmaceutical production by the FDA and the Department of Justice.• Responsibilities included Regulatory, QA, QC, Process Validation/Engineering, Method Development/Validation, and Microbiology, for dietary supplement production and future pharmaceutical production. • Spent 1.5 years re-inventing the company’s Quality systems, re-writing company procedures and overhauling the QA/QC department.• Implemented and executed Quality systems for contract manufacturing, packaging, testing, and release of dietary supplements / nutritionals (liquids, capsules, tablets). Produced hundreds of batches of nutritionals during this time (allowed per Consent Decree sanctions).• Passed certification inspection in July 2008 from Dallas FDA, with no 483 Observations. • Upon being allowed to resume pharmaceutical production by FDA in 2008, began clinical trial for an ANDA for a generic equivalent to Tussionex, a long-acting suspension for cough/cold treatment.• In charge of writing the Chemical and Manufacturing Controls (CMC) section of the ANDA, along with all associated Stability Reports, Method Validation Reports, and drug substance / excipient / drug product specifications.• ANDA for Tussionex Generic submitted to FDA in October 2009.• In charge of the Pre-Approval Inspection (PAI) for Tussionex Generic, conducted by Dallas FDA. Obtained PAI approval in May 2011.• Authored/edited/managed all responses to CDER regarding their questions related to the ANDA for Tussionex Generic.• Obtained FDA approval for Tussionex Generic in 2012, becoming only the 2nd Tussionex Generic drug approved since the original Tussionex was approved in 1987.• Directly involved with NSF certification for dietary supplements / nutritionals, per the request of a contract manufacturing client.

• After Adams Respiratory Therapeutics re-purchased the facility from Cardinal Health, I concluded an 18-year career at the same facility by overseeing Product Development, Validation/Engineering, and Maintenance while still managing post-approval CMC submissions to FDA for Mucinex, Mucinex DM, and Mucinex D.• Responsibilities included FDA submissions of process improvements via Changes Being Effected (CBE) supplements and all validation / qualification activities for Mucinex, Mucinex DM, and Mucinex D.• Third consecutive FDA cGMP inspection with no 483 Observations in August 2006, validating the Quality systems put in place during the past decade as the highest-ranking Quality executive in the plant.• Company sold for $2.3 billion to Reckitt Benckiser 11 months after concluding my career (longest-tenured employee in the facility at the time of my departure in January 2007).

Dublin, Oh, Us

• After Cardinal Health purchased the Adams Laboratories (Mucinex) facility, formally added Regulatory and Compliance responsibilities to existing leadership of Quality Assurance, Quality Control (Laboratories), and Validation/Engineering.• Grew department from one shift to a 24-hours-a-day / 7-days-a-week operation, to handle increased demand for Mucinex. Responsible for 90 – 100 employees.• Helped grow company to $400 million in yearly sales for Mucinex, Mucinex DM, and Mucinex D.• Managed second consecutive FDA cGMP inspection with no 483 Observations in April 2004.

• One of the primary participants in FDA approval of Mucinex, Mucinex DM, and Mucinex D.• Composed the CMC section for Mucinex, Mucinex DM, and Mucinex D NDA submissions.• Responsible for responses to FDA Deficiency Letters related to the Mucinex, Mucinex DM, and Mucinex D NDAs.• In charge of successful FDA pre-approval inspection for Mucinex, conducted by Dallas FDA in February 2001.• Managed FDA cGMP inspection in November 2002, which resulted in no 483 Observations.• Supervised a staff ranging from 20 – 42 employees. Responsibilities included Quality Assurance, Quality Control (Laboratories), Validation, and Product Development.

Bachelor'S Degree, Biochemistry

Education record