Extensive regulatory affairs' experience in the pharmaceutical Rx drug industry in leadership and hands-on roles in the areas of: PML (Product Life-Cycle Management) of Rx drugs. Resulted in the submission / maintenance of many INDs, NDAs and ANDAs and 1 BLA, including INDs and changes to product labeling, CMC and efficacy information. IND / NDA / ANDA data and text documents / sections. Clinical regulatory affairs documents / data including, in concert with the statistician, a review of SAPs. Review human Rx drug promotional labeling / package inserts. Review drug product batch records for consistency. Submitted NDAs, ANDAs and original INDs that met FDA's regulations and company objectives within budget and established timeframes. Applied to Rx drug products with the following administration routes: oral (tablets/capsules, liquids/suspensions), intravenous, ophthalmic and topical). Reviewed/approved all change control requests from a US regulatory perspective of a botulinum Type B parenteral for 4 years, categorizing changes requiring supplements as CBEs, CBE-30s and PASs. Highly motivated with successful implementation of regulatory tactical objectives by effective communication with the FDA and across several company functional units (e.g., QA/QC, R&D, Clinical) Well-versed in the following therapeutic areas: central nervous system (CNS), anti-infective, antihypertensive, cardio-renal, gastro-intestinal, endocrine, and anti-inflammatory/analgesic. Extensive experience in preparing amendments/supplements to a BLA (a botulinum toxin, Type B injectable biologic product). Thorough knowledge of FDA and ICH regulations in Rx drug development. Liaised with FDA relating to INDs, NDAs ANDAs and BLAs. Proven track record in developing strategic labeling and promotional materials that resulted in successful product launches. Reviewed and was the regulatory signatory for hundreds of promotional pieces involving direct interactions with the ad agencies/Marketing/Sales/Medical Affairs with all pharmaceutical companies in which I was employed. Developed the labeling for several Rx drug products. Directly interacted with OPDP (aka, DDMAC) relating to promotional materials for Rx drug products.
Senior Regulatory Specialist December 2010 to July 2014US WorldMeds, LLC － Louisville, KY
Reviewed/approved all change control requests from a US regulatory perspective for a botulinum Type B parenteral for 4 years, categorizing changes requiring supplements (CBEs, CBE-30s and PASs).
Prepared/submitted to FDA.
Peckels Page 2 Maintained regulatory requirements for products (e.g., annual reports, drug listings, establishment registrations, PFUFA product/establishment user fees, periodic adverse drug experience reports).
Developed regulatory pathways for the addition of new products/indications.
Performed Rx drug product regulatory due diligence for in-licensing new products.
Prepared Meeting Requests/Packages for various products and communicated with FDA (face-to-face/, telephone and written correspondence).
Researched and obtained information to support NDAs, ANDAs, INDs, and corresponding amendments/supplements.
Worked with the appropriate department personnel to revise drug product labeling.
Researched rules for submitting trade names and submitted same in conjunction with other colleagues on the RA team.
Reviewed 21 CFR/ICH Guidances and the Federal Register to keep current with regulatory requirements.
Prepared and submitted amendments and Annual ANDA/NDA/BLA reports.
Compiled, edited, and submitted to FDA INDs, NDAs (including amendments and supplements ) to a biological license application (BLA).
Reviewed and offered all regulatory assistance to Marketing and Sales on promotional materials / labeling.
Performed due diligence and provided regulatory input in for products being sought by the company.
Supported company in accordance with US regulations and FDA guidances, in maintaining the marketing status of their drug products via amendments, supplements, ADE reports, annual ANDA, NDA and BLA reports)and submitted same to FDA.
Reviewed/approved all change control requests from a US regulatory perspective.
Submitted input to FDA re: PDUFA User and Establishment License Fees for each fiscal year.
Prepared in concert with Clinical Operations) responses to FDA deficiency letters (e.g., the company's BLA and the BLA INDs for new indications) and submitted same to FDA.
In collaboration with other RA colleagues, was responsible for preparing the regulatory budget.
Regulatory Affairs Consultant April 2010 to December 2010US WorldMeds, LLC － Louisville, KY
Reviewed all promotional materials and internal Marketing Representatives' training materials for marketed products from an RA perspective.
Performed miscellaneous RA projects (e.g., Annual Reports and promotional labeling reviews) for a marketed product.
Completed with an outside contracted firm an FDA-mandated 18-month REMS study report for a biological drug product and submitted same to FDA.
Regulatory Affairs Consultant August 2009 to March 2010Protocol Link, Inc － Lake Forest, IL
Developed regulatory strategies for post-marketing supplements (ANDAs and NDAs) including labeling and manufacturing site changes (drug substances and drug products).
Regulatory Head of Promotional Review Board working both independently and in concert with legal and medical consultants and with Marketing in the development of promotional campaigns and review/approval of promotional materials (~200) for a number of proprietary and generic Rx drugs for a client.
The majority of products were injectables for various indications (e.g., anesthesia, interstitial cystitis, varicose veins of lower extremities).
Interacted with DDMAC (aka OPDP) on current promotional climate and confirmed CDER impact on newly-revised PhRMA Code.
Regulatory Affairs Consultant May 2009 to March 2010Donald R. Peckels US WorldMeds, LLC － Louisville, KY
Provided regulatory guidance to ensure post-marketing activities associated with the company's product were in compliance with FDA's regulations and guidances.
Provided regulatory strategies and communications to FDA in response to CMC deficiencies relating to a labeling/CMC supplement for an enhanced reconstituted feature for the company's small volume parenteral [SVP]; approval granted in less than 3 months.
Collaborated with marketing department to develop strategies to maximize increased commercialization potential of all promotional materials.
Provided sole regulatory review of all promotional materials (~250).
Interacted with DDMAC on preclearance procedures re: audio/ visual promotional pieces.
Interacted with DDMAC re: prior-approval labeling and CMC supplement to obtain approval of a proprietary name for the company's sole product manufactured by a modified process that improved a safety feature.
Utilized newly-issued FDA guidance to ensure that all required elements were accounted for and comprehensively included same in the supplement.
Manager October 2008 to April 2009Akorn, Inc － Lake Forest, IL
Supervised 4 Associates in all life-cycle (compliance) management activities for more than 80 Rx drugs and 20 OTC drugs (SVP and ophthalmic drug products).
Projects included labeling and CMC supplements, Annual Reports, Periodic ADE Reports and drug listing.
Provided regulatory advice to the Vice President, Regulatory Affairs on CMC issues related to approved products and provided regulatory strategy on implementing CMC changes and submitting them to the FDA in accordance with the regulations.
Managed regulatory assessment and submission tactics for all CMC change control notices (~500) for approved ANDAs.
Involved with cGMP activities via direct interactions with QA.
Responsible for the regulatory review and approval of all promotional materials (~150) and new and revised labeling.
Interacted with DDMAC re: promotional claim for NDA product approved with only one small supportive clinical study.
Reviewed reformatted batch records for drug products to ensure accuracy and completeness were maintained.
Director October 2007 to October 2008US WorldMeds, LLC － Louisville, KY
Prepared and obtained approval of an ANDA (for a SVP generic drug used to treat malignant hyperthermia).
Interacted with drug product manufacturer to ensure all required CMC documents were generated in support of the company's ANDA.
Provided global regulatory advice with ex-US regulatory consultant to expand marketing rights for the company's product in Canada and EU.
Advised consultants and department personnel in a regulatory capacity to prepare an NDA in CTD format for a drug product with a new chemical entity for a potential blockbuster non-narcotic drug to alleviate withdrawal symptoms related to opioid addition.
Directly responsible for the regulatory review and approval of all promotional materials (~250) and new and revised labeling.
Worked directly with Marketing and the ad agency that resulted in the creation / implementation of all promotional materials that achieved company's timelines and were compliant with FDA's regulations.
Peckels Page 4 Interacted with DDMAC re: first of two prior-approval labeling supplements to obtain approval of a suitable proprietary name for the company's sole product manufactured by a modified process that dramatically improved the product's reconstitution time.
Prepared CMC supplement to the company's ANDA that provided an enhanced safety feature.
Utilized FDA and ICH guidances to ensure that all required elements were accounted for and comprehensively included in the supplement.
Director May 2004 to September 2007Morton Grove Pharmaceuticals, Inc － Morton Grove, IL
Created an expanded Regulatory Affairs Department and supervised 6 Associates, 1 document coordinator and 3 labeling personnel in all life-cycle management activities for ~ 60 Rx generic drugs Projects included review of all Annual Reports, Periodic ADE Reports, drug listing and pharmacovigilance.
Prepared and submitted CMC supplements.
Led the efforts with R&D in preparing CMC data packages to support the submission of 8 ANDAs and 12 CMC supplements.
Included the review of batch records.
Managed the regulatory assessment of all CMC change control notices to approved ANDAs (~2400 annually).
Involved with other cGMP activities via direct interactions with QA.
Directly responsible from a regulatory perspective for the review and approval of all promotional materials (~300) and new and revised labeling.
Interacted with DDMAC to ensure compliance with products with boxed warnings in the package inserts.
Associate Director April 1999 to April 2004Fujisawa Healthcare, Inc Astellas Pharma US, Inc － Deerfield, IL
Directed the regulatory efforts in preparing several INDs, NDAs and ANDAs (cardiovascular, anti-infective and analgesic/inflammatory, hepatoprotectant and CNS drugs), CMC amendments and CMC/labeling supplements.
Participated as the regulatory team leader in preparing 4 briefing documents for FDA Pre-IND and End-of-Phase 2 meetings that resulted in successful outcomes.
Represented regulatory affairs on 5 project teams in the development and IND/NDA transfers of several applications (cardiovascular, anti-inflammatory) and assisted a partnered company in the development of a cardiovascular SVP drug in Phase 3.
Advised and strategized in a global regulatory capacity with the parent company and its German and Canadian subsidiaries in generating regulatory documents for foreign market license applications.
Directly responsible for the regulatory review and approval of ~400 promotional materials for 7 major products.
Served as Head of promotional review committee for assigned products, involving interactions with marketing (and its ad agency), clinical, scientific affairs, legal and DDMAC.
Director February 1997 to March 1999Unimed Pharmaceuticals, Inc － Buffalo Grove, IL
Established the company's Regulatory Affairs Department.
Supervised activities to generate documents for 2 fileable NDAs (anti-infective and topical endocrine drugs).
One NDA was approved in less than 7 months; drug yielded revenue of $112M during the first year and ~$200M annually thereafter.
Maintained all INDs/NDAs and handled all ADE inquiries from physicians and patients.
Peckels Page 5 Provided strategic guidance to senior management and conducted due diligence for the successful in-licensing of 6 Rx products.
Prepared RA strategy and meeting materials for all FDA Meetings and Advisory Committee Meetings.
Directly responsible for the review and approval of all (over 300 promotional materials) and the conduct of all life-cycle management activities, including labeling and CMC supplements, Annual Reports, Periodic ADE Reports and drug listing.
Associate Director April 1983 to January 1997Monsanto/G.D. Searle & Co － Skokie, IL
Prepared information / data for submissions of INDs, NDAs, ANDAs, NDA amendments and supplements, and DMFs, and performed life-cycle management for these submissions.
Interacted with FDA as the lead regulatory affairs advisor for an NSAID that was approved within 1 year after joining the team.
Presented regulatory strategies for new products and served as regulatory liaison in face-to-face FDA meetings and teleconferences.
Directly responsible for the RA review and approval of promotional materials for 8 major products Served as Regulatory Head of promotional review committee for assigned products, involving interactions with marketing (and its ad agency), clinical, scientific affairs and legal.
Participated in face-to-face meeting with DDMAC re: preclearance of initial marketing materials for newly-approved products.
Interacted extensively with DDMAC re: Direct-to-Consumer promotions / advertisements.
Regulatory Affairs Associate R&D Chemist QC Lab Chemist June 1966 to March 1983Mallinckrodt, Inc － St. Louis, MO
Bachelor's : ChemistryUniversity of Minnesota － Minneapolis, MNChemistry
FDA Regulations: Excellent working knowledge of 21 CFR (Part 200 series relating to labeling and advertising), and Parts 211, 312, 314 and 600 Writing skills: Strong structure and content knowledge of the English language, including definitions, spelling, grammar and vocabulary Verbal communication: Excellent verbal communication skillset Computer: Windows, MS Word and MS PowerPoint