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The document provides a summary and experience for John Salveta, who has extensive experience in Regulatory Affairs for FDA regulated pharmaceuticals. He has led teams developing drug and drug-device products and has experience managing products from development through approval and post-approval changes.

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29 views2 pages

Sample

The document provides a summary and experience for John Salveta, who has extensive experience in Regulatory Affairs for FDA regulated pharmaceuticals. He has led teams developing drug and drug-device products and has experience managing products from development through approval and post-approval changes.

Uploaded by

ashh3417
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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John Salveta

18931 Tipsico Lake Rd.


Fenton, MI 48430
Email: [email protected]
Phone: 978.727.4581

SUMMARY

A versatile professional with extensive experience in Regulatory Affairs in FDA regulated pharmaceutical
environments. Competent in leading and participating on teams in the development of single drug products
and combination drug-device product and in managing product lifecycle from original IND through NDA
approval and post-approval changes. Interact with pharmaceutical professionals at all levels up to VP.
Knowledgeable in 21 CFR Parts 210 and 211, and 21 CFR Part 820.

EDUCATION & DEVELOPMENT

Master of Science Regulatory Affairs & Health Policy, Massachusetts College of Pharmacy, Boston, MA
Master of Business Administration, Clemson University, Clemson, SC
Bachelor in Chemistry, Wayne State University, Detroit, MI
Project Management Certificate, Boston University, Boston, MA

EXPERIENCE

Sunovion Pharmaceuticals Inc., Marlborough, MA


Director, CMC Global Regulatory Affairs 2008 – 2018
Ensured CMC regulatory requirements for human pharmaceutical products were met during the
development of new products for US and Ex-US studies up to NDA approval, and during the product life
cycle of US marketed products.
 Provided CMC expertise and counsel to global teams and partners supporting several drug
products at both pre- and post-marketing stages.
 Experienced in Drug-Device combination product development. Responsible for CMC drug
product and device regulatory support in development and approval of Lonhala Magnair
combination product.
 Led the preparation of numerous US and Ex-US CMC sections of regulatory submissions in
support of clinical operations.
 Served as the principle regulatory liaison in interactions with the FDA on CMC matters relating to
pharmaceutical development projects and post-marketed products. Led teams in preparation for
FDA meetings regarding CMC issues or concerns.
 Built effective relationships both within the Global RA organization and between RA and global
product development teams.
 Chaired US Regulatory Affairs CMC forum meetings.
 Provided input and support for product labeling approval and revisions.

Associate Director, CMC Regulatory Affairs 2005 – 2008


 Regulatory lead for the CMC sections of NDA submission for Brovana (first round approval
$100M/YR).
 Authored and compiled CMC sections of INDs, and CTAs, new drug applications through
collaboration with Technical Development and other departments.
 Directed regulatory activities and support (Phase 4) for Brovana, Xopenex, and Lunesta.
 Compiled and submitted electronic SNDAs and IND amendments using e-CTD format. Provided
leadership in the migration to the e-CTD format for all regulatory filings.
 Participated in Clinical Trials Material Team meetings to assure drug product is manufactured,
released, and delivered in a timely manner to support Clinical Studies.
Vertex Pharmaceuticals, Cambridge, MA
CMC Manager, Regulatory Affairs 2003 – 2004
Managed the regulatory process for CMC of numerous internal and partnered breakthrough drug products
through development and approval stages.
 Authored and compiled CMC sections of INDs, NDAs, CTAs, MAAs, and other global new drug
applications through collaboration with Technical Development and other departments.
 Led, developed and executed detailed project plans for CMC aspects of regulatory submissions.
 Resolved CMC issues that arose during or after product development and coordinated solutions
with Technical Development, Quality Assurance, Pharmacology, and Toxicology.
 Approved specifications, methods, batch records, and stability protocols for API and drug product
manufacturing. Ensured timely audits of API manufacturing facilities, Clinical Material
Manufacturing, and Analytical Laboratories to meet project timelines.
 Planned compiled, and reviewed amendments for CMC changes and responses to regulatory
agency review findings. Interacted directly with regulatory agency representatives, as needed.

AstraZeneca, Westborough, MA
Senior Manager, CMC/Documentation Technical Service 2002 – 2003
Directed the personnel and systems responsible for site Master Batch Records, Standard Operating
Procedures, and Change Control.
 Administered, controlled, and maintained compliance of GMP documentation for site SOPs and
Master Batch Records.
 Led the site project team in the development of a centralized, electronic change control system
for validation, computer systems, laboratory instruments, and process equipment.
 Participated on the site project team to develop an interface between the Master Batch Record
system and the rollout of mySAP EPR system.
 Collaborated with other AstraZeneca sites to establish common practices, procedures, and
platforms for revising and maintaining Master Batch Records, and SOPs.

CMC/Documentation Services Manager, Compliance Technical Services 1999 – 2002


Managed the personnel and systems responsible for site CMC, Pre/Post Approval Readiness Audits, and
Document Change Control. Functioned as the Compliance Technical Services FDA liaison.
 Compiled, authored, and reviewed site CMC documentation for new products, supplemental
submissions, post-approval changes, and FDA Annual Reports.
 Collaborated with Site cross-functional teams, Corporate Product Industrialization Group and
Global Dossier Management Group to identify responsibilities and create timelines for CMC
submissions to the FDA.
 Conducted product specific pre/post approval audits, with emphasis on technology transfer,
process validation, cleaning validation, and analytical methods development. Reported findings
and identified follow-up actions, resulting in expedited and successful FDA final reviews and
approvals.
 Established and executed annual employee Performance Management Plans integrated with site
business objectives and measured through Key Performance Indicators.

CMC Compliance Manager, Compliance Technical Services 1999 – 1999


Oversaw the processes and personnel responsible for CMC documentation, and operations related
compliance investigations.
 Created and implemented the process to conduct Pre-Approval readiness audits concurrent with
regulatory submission compilation.
 Led Quality Problem Observation Report (PORs) investigations and activities associated with site
equipment, sterile/non-sterile processes, critical systems, and components.

Finished Product Laboratory Manager, Quality Assurance 1995 – 1999


Responsible for the overall Finished Product Laboratory 3-shift operation assuring cGMP and cUSP
compliance, with budget responsibility of over $10M. Improved customer service levels by 25%.

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