Lorraine Torres

Lorraine Torres Email and Phone Number

Sr. Director Regulatory Affairs @ FibroGen, Inc.
san francisco, california, united states
Lorraine Torres's Location
Wake Forest, North Carolina, United States, United States
Lorraine Torres's Contact Details

Lorraine Torres personal email

n/a
About Lorraine Torres

Recognized leader with 30 years experience in the pharmaceutical industry in quality, quality control and regulatory affairs roles. Proven experience in the quality and life cycle regulatory aspects of the manufacturing of small and large molecule drugs substances and products. Leader with experience managing in-person and remote teams, maintaining direction and balancing regulatory requirements while meeting the demands of dynamic manufacturing operations. Able to develop insightful regulatory strategies for managing CMC changes, strong negotiator and problem solver. Excellent team player with superior negotiation skills, problem solving expertise and dependability. Significant experience managing: • CMC Regulation Strategy Development • CMC NDA and BLA Supplements, Global Variations• Product Transfers and Licensed Applications• CMC NDA and BLA Supplements, Global Variations • GMP Regulations• Global Regulatory Agencies Inspections• Regulatory Compliance• Field Alerts and BPDRs Submissions• Drug Master Files, Site Master Files• Training and Mentoring

Lorraine Torres's Current Company Details
FibroGen, Inc.

Fibrogen, Inc.

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Sr. Director Regulatory Affairs
san francisco, california, united states
Website:
fibrogen.com
Employees:
419
Lorraine Torres Work Experience Details
  • Fibrogen, Inc.
    Senior Director Regulatory Affairs
    Fibrogen, Inc. Sep 2022 - Present
    Remote
    Responsible for leading CMC regulatory activities for innovative small molecule and biologics throughout the lifecycle of the product (IND, NDAs, BLAs). This role is accountable for working closely with cross-functional subject matter experts in Quality, Product development, Manufacturing and Regulatory Affairs to ensure a robust CMC regulatory strategy is developed and implemented to have on time submissions with the highest quality to meet global health authority expectations.
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  • Amgen Manufacturing, Limited
    Director, Regulatory Affairs Cmc
    Amgen Manufacturing, Limited Aug 2006 - Sep 2022
    Juncos, Puerto Rico
    Provide leadership and oversight to the regulatory CMC teams located in Amgen manufacturing sites in Puerto Rico, Ireland and Netherlands. Influence the development and execution of regulatory strategies for reporting life cycle management changes globally. Support global product registration activities and launches, change controls, deviations and CAPAs. Maintain site abreast of new regulatory requirements, including assessing impact to product registrations and processes. Provide training to cross functional teams on regulatory topics as needed.
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  • Eli Lilly And Company
    Manager, Regulatory Affairs Cmc And Quality
    Eli Lilly And Company Jun 1996 - Jul 2006
    Carolina, Puerto Rico
    Provide regulatory support to all Lilly manufacturing facilities in Puerto Rico, drug substance and drug product. Also had oversight of the drug product stability area and quality documentation systems.
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Lorraine Torres Skills

Regulatory Affairs Gmp Biopharmaceuticals Pharmaceutical Industry Fda Change Control Biotechnology Cmc Technology Transfer Validation Capa 21 Cfr Part 11 Aseptic Processing V&v Regulatory Submissions Sop

Lorraine Torres Education Details

Frequently Asked Questions about Lorraine Torres

What company does Lorraine Torres work for?

Lorraine Torres works for Fibrogen, Inc.

What is Lorraine Torres's role at the current company?

Lorraine Torres's current role is Sr. Director Regulatory Affairs.

What is Lorraine Torres's email address?

Lorraine Torres's email address is lo****@****gen.com

What schools did Lorraine Torres attend?

Lorraine Torres attended Inter-American University Of Puerto Rico-Metropolitan Campus, University Of Puerto Rico-Rio Piedras.

What are some of Lorraine Torres's interests?

Lorraine Torres has interest in Avid Runner And Cyclist.

What skills is Lorraine Torres known for?

Lorraine Torres has skills like Regulatory Affairs, Gmp, Biopharmaceuticals, Pharmaceutical Industry, Fda, Change Control, Biotechnology, Cmc, Technology Transfer, Validation, Capa, 21 Cfr Part 11.

Who are Lorraine Torres's colleagues?

Lorraine Torres's colleagues are Anne O'con, Akschy Peer, Cafe Fibrogen, Aida Autrand, Heather Perritt, Matthew Yu, Sreekant (Sree) Nadkarni.

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