Fred Longenecker Email & Phone Number
@ge.com
1 phone found area 203
LinkedIn matched
Who is Fred Longenecker? Overview
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Fred Longenecker is listed as Chief cook and bottle-washer at Retired and enjoying life and time with my family, based in Greater Boston, United States, United States. AeroLeads shows a work email signal at ge.com, phone signal with area code 203, and a matched LinkedIn profile for Fred Longenecker.
Fred Longenecker previously worked as Director, Regulatory Affairs at Ge Healthcare and Asociate Director, Regulatory Affairs at Novo Nordisk Pharmaceuticals, Inc. Fred Longenecker holds Ms, Physiology from Rutgers University.
Email format at Retired and enjoying life and time with my family
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About Fred Longenecker
· 30 years broad-based RA experience with a strong background in drug regulatory development and compliance· A self-starter, who works equally well independently, with departmental coworkers/leaders, or in international, cross-functional teams and FDA managing all RA aspects of drug/device development to meet submission/approval targets· Can manage the people and regulatory aspects of getting and keeping a product on the market including planning coordinating and running FDA meetings / study design and labeling negotiation, promotion review, OPDP interactions, GXP compliance/inspections and regulatory intelligence/drug development and product life cycle strategy· Specialties: FDA liaison and drug development strategy and maintenance for:· Medical imaging pharmaceuticals· Diabetes care pharmaceuticals and injection devices· Narcotic analgesics· Cardiovascular agents
Listed skills include Us Drug Regulatory Affairs Strategy And Life Cycle Maintenance, Us Drug Promotion And Advertising Compliance Review And Guidance, Us Drug Labeling Development And Negotiation, Cross Functional Team Leadership, and 22 others.
Fred Longenecker's current company
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Fred Longenecker work experience
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Director, Regulatory Affairs
Participated in or ran RA development activity for 8 new medical imaging drugs, bringing 4 to the US market and managed life cycle activities for over 10 marketed products, including the addition of 3 new indications and obtaining DEA de-scheduling of one product. I have managed the RA development (4 people) and labeling (2 individuals) groups and.
Asociate Director, Regulatory Affairs
Filed/managed 2 INDs [and managed 9 others] in the diabetes care portfolio, one of which I took to FDA approval. I managed life cycle activities for all insulin products and delivery devices, including a cross-product clean-up of a CMC compliance issue. I handled advertising/ promotion compliance for all products in the diabetes care portfolio.
Manager, International Regulatory Affairs
Interacted with international regulatory authorities to maintain products in the oral and topical anti-inflammatory agent portfolio, including one investigational agent
Regulatory Associate
Filed and maintained over 15 DMFs for the fine (drug) chemicals portfolio and 3 INDs and NDAs for marketed narcotic analgesic agentsand hypertensives. For the later I also performed advertising/promotion compliance review
Supervisor, Regulatory Affairs
Managed the SOP and batch record systems for manufacture of bulk and finished product injectable penicillin products. Maintained the CMC section of the penicillin NDAs. Performed batch record reviews, product failure investigations, and cGMP compliance audits.
Consultant, Regulatory Affairs
Conducted compliance audits of animal toxicology studies for NDA drugs and EPA pesticide agents.
Fred Longenecker education
Ms, Physiology
Bs, Biology
Frequently asked questions about Fred Longenecker
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What company does Fred Longenecker work for?
Fred Longenecker works for Retired and enjoying life and time with my family.
What is Fred Longenecker's role at Retired and enjoying life and time with my family?
Fred Longenecker is listed as Chief cook and bottle-washer at Retired and enjoying life and time with my family.
What is Fred Longenecker's email address?
AeroLeads has found 1 work email signal at @ge.com for Fred Longenecker at Retired and enjoying life and time with my family.
What is Fred Longenecker's phone number?
AeroLeads has found 1 phone signal(s) with area code 203 for Fred Longenecker at Retired and enjoying life and time with my family.
Where is Fred Longenecker based?
Fred Longenecker is based in Greater Boston, United States, United States while working with Retired and enjoying life and time with my family.
What companies has Fred Longenecker worked for?
Fred Longenecker has worked for Retired And Enjoying Life And Time With My Family, Ge Healthcare, Novo Nordisk Pharmaceuticals, Inc, Schering-Plough Research Institute, and Knoll Pharmaceuticals.
How can I contact Fred Longenecker?
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What schools did Fred Longenecker attend?
Fred Longenecker holds Ms, Physiology from Rutgers University.
What skills is Fred Longenecker known for?
Fred Longenecker is listed with skills including Us Drug Regulatory Affairs Strategy And Life Cycle Maintenance, Us Drug Promotion And Advertising Compliance Review And Guidance, Us Drug Labeling Development And Negotiation, Cross Functional Team Leadership, Drug Development, Technical Writing And Editing, Clinical Development, and Cardiology.
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