Benjamin Johns Email & Phone Number

Warminster, Pa, Us

Princeton, New Jersey, Us

Developing and executing the global regulatory CMC strategies for assigned oncology projects to ensure successful regulatory approval. Leading regulatory CMC in cross-functional SME team to facilitate the development of various oncology products. Identifying, communicating, and proposing resolutions to routine and complex CMC strategy issues. Leading and providing hands on support for the development and timely delivery of global regulatory CMC submission documents to support the clinical trials (IND, CTA) marketing (NDA, MAA, and post approval/lifecycle management applications (PAS, CBE, AR, Variations). Identifying and effectively communicating the regulatory opportunities and risks to the development team and senior management. Representing as a liaison to health authorities and addressing Agency questions/information requests, as required. Preparing briefing package and leading CMC related Agency meeting. Collaborating with overall CMC development plan for drug substance and drug product development and thereby assess the regulatory risks from early to late stage clinical & registration. Managing CMC related regulatory timelines and deliverables based on overall project planning & corporate goals, as appropriate.

Madrid, Madrid, Es

As a regulatory strategy lead, managed new projects under development and approved commercial products and line extensions of NDA products. Supported commercial operations & supply chains on post approval changes. Provided regulatory support to generate CMC documentations for IND and CTA applications. Worked closely with cross-functional team including R&D, manufacturing, marketing, quality, analytical labs. Worked on several post approval regulatory submissions such as PAS, CBEs & annual reports. Communicated with FDA to facilitate the approval process. Supported R&D team with controlled correspondence, comparability protocol and briefing package. Managed the Chemistry, Manufacturing, and Controls (CMC) of various developmental products and successfully submitted to FDA for approval. Managed CROs & the testing labs to generate analytical study protocols, test method validations and data generation as per FDA guidance to evaluate product quality as per ICH guidelines. Provided regulatory support to contract laboratories and manufacturing sites on marketed products & also developmental projects.

Leverkusen, North Rhine-Westphalia, De

Developed regulatory strategies for line extensions of Rx and OTC switch products product portfolio. Generated global regulatory submission packages in eCTD platform and collaborated with functional groups such as research, marketing, quality, and manufacturing to manage regulatory timeline and deliverables. Provided regulatory impact assessments and generated submission strategies for post approval changes. Supported global regulatory team as and when required to answer formal health authority questions. Worked closely with internal and external DMF holders, manufacturing sites and raw material suppliers to manage change controls and to support the post approval submissions. Interacted directly with FDA for CMC related regulatory updates and managed pending regulatory approvals.

Rahway, New Jersey, Us

Strategically assessed the technology transfer programs and post approval changes proposed by the cross-functional teams at global manufacturing sites of Merck and Schering Plough. Managed Rx and Rx to OTC switch products portfolio as per US regulatory requirements. Generated regulatory document summaries in eCTD and worked closely with the publishing group to submit the application to FDA. Provided regulatory strategy and impact assessment on change controls. Supported to harmonize the regulatory procedures within global regulatory team, and acted as a point of contact for assigned product portfolio. Generated submission ready components, circulating through electronic documents management repository for review approval and prepared the package & supported the regional submission (EU, US & RoW) as required.

New York, New York, Us

Supported the global regulatory team and provided strategies for post approval changes to Rx/OTC products approved at various global markets. Interacted closely with different functional teams, assessed post approval change controls and provided regulatory impact assessment on the proposed change prior to implementation. Authored relevant granular CTD submission components for PAS, CBE and AR submission as required in conjunction with analytical methods, product development summary in CTD format and worked closely with the publishing group to get it filed electronically. Supported the technical operation and supply chain groups and performed regulatory impact assessment on changes related to drug substances, drug products, analytical specs & methods and packaging components. Utilized electronic document management systems & software to expedite, manage and track regulatory documents for comment resolution.

Supported multiple pharmaceutical clients to generate ANDA applications and submitted to FDA. Authored CMC sections (Module 2 and 3) and managed clinical sections (Module 5) for several ANDA drug product applications (Oral solid and liquid dosage forms). Authored quality overall summary (QOS) based on QbR and reviewed functional documents including analytical specs & methods, validation, manufacturing documents etc., to ensure they were in compliance with ICH and FDA guideline. Supported drug master file (DMF) submissions as per CTD format and reviewed the functional documents for granularity and consistency. Worked closely with the publishing group to generate the eCTD and submit the application to FDA. Worked on several post approval submissions such as PAS, CBEs & Annual reports and submitted to FDA.

Us

Lead the drug product developmental activities including solid oral dosage (SOD) forms (IR & MR), semi-solid (cream & gel) and liquid (suspensions & nasal spray) products. Managed formulation & tech transfer from lab to pilot plant and supported manufacturing Phase I, II or III clinical trial materials. Provided support to quality initiatives including design of experiments (DOE), quality by design (QbD) and process analytical technology (PAT) approaches in product and process development. Provided technical support to CROs and material suppliers and managed the incoming material changes as and when required. Generated, reviewed, and/or approved necessary documents and reports pertain to cGMP manufacturing, regulatory (CMC) submission (IND and NDA). Supported portfolio/strategy team to select lead candidate, budget projection, CRO & besides provided technical support for potential patentability and exclusivity. Supported regulatory team to address the information requests and attended meeting with the FDA reviewers and project managers to facilitate the submission review process. Lead project teams (QA, RA, Mfg., AR&D), supervised scientists to managing cross- functional teams.

Ingelheim Am Rhein, Rhineland-Palatinate, De

Formulations for super generics [505 (b) (2)], paragraph IV and regular generic products were developed and continued to scale up and transfer the technology to internal production facility, troubleshoot the commercial manufacturing process, manufacture clinical trial material (CTM) for pilot and pivotal bio-equivalence studies. Reported to core team of senior management and directed cross-functional team (RA, QA, AR&D, R&D, Mfg) meetings and acted as project manager to achieve project goals. Technical operations support including but not limited to scale up, technology transfer and process optimization studies using QbD approach, qualification of alternative suppliers, validation and troubleshooting manufacturing issues were provided. Provided support for post approval changes (SUPAC) to commercial manufacturing operations in close alliance with regulatory affairs and supply chain to meet market demand. Technical documents were generated, reviewed/approved to support cGMP manufacturing and CMC section of the regulatory submission in addition to internal reports, study protocols, investigations, batch records, etc. Facility audit supports and managed the project operations at CRO and CMO sites, provided scientific and technical guidance to developmental programs at contract manufacturing sites. Generated/reviewed change controls (CCR) and CAPA programs and worked closely with QA team.

Designed pre-formulation studies and drug product formulation development, manufacturing registration/ bioequivalence batches for developing products under section [505 (b) (2)], paragraph IV and regular generic products. Developed several generic drug products of immediate release (IR) and modified release (MR) in addition to sublingual, orally disintegrating (ODT) products. Drug products were developed based on targeted drug release mechanisms based on novel technologies currently available for controlling rate of drug release. I was involved in designing IVIVC studies, drug product stability studies, process validation and cleaning validation programs. I was also involved in packaging component selection and validation of packaging process for drug products under development. Generated SOPs, change control reports (CCR) and post approval change (SUPAC) plans within the guidance. I was a member to the quality management team to assess change controls, investigations, CAPA plans and training. I was involved in technology transfer and process validation programs in addition to supporting regulatory affairs team by authoring documents pertaining to pharmaceutical development, formulation and manufacturing process. I was part of the CMC review team and used to review the final submission package (CMC section) prior to submission.

As a production supervisor, I had provided technical support to R&D team and supported scale up and technology transfer programs from lab to in-house production facility. Provided technical support for manufacturing clinical supplies, exhibit batches, scale up and process validation batches. Actively participated in team meetings and scheduling & planning for drug product manufacturing. Managed raw materials inventory and packaging component’ inventory as per sales and marketing forecast. Supervised manufacturing operations for solid, semi-solid & liquid oral dosage forms in cGMP plant and also managed 16 production operators at rotating shifts. Managed operator’ schedules, timesheets and training.

Doctorate In Healthcare Administration (Phd)

Master Of Science - Ms, Industrial Pharmacy