Legend Biotech Corp.
Associate Director of Regulatory CMC
Legend Biotech Corp., Trenton, New Jersey, United States,
Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell and natural killer (NK) cell-based immunotherapy.Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel) in 2017. Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking an
Associate Director, Regulatory CMC as part of the
Regulatory Affairs team based in
Somerset, NJ.Key ResponsibilitiesServes as the regulatory CMC representative on core teams, develops and plans regulatory CMC submission strategy with a focus on allogeneic gene-edited products.Provides guidance to technical team members for the requirements, especially on the unique requirements on gene editing technologies and allogeneic therapies. Identify the required documentation to support global submissions and coordinate the delivery of approved technical source documents in accordance with project timelines.Provide guidance on allogeneic and gene-edited product development at the R&D phase.Coordinates and manages CMC regulatory submissions, applying CMC global regulatory strategies.Prepare briefing books for Health Authority meetings.Facilitate consistency within the CMC regulatory documentation by sharing experience and/or contributing to template maintenance.Establish and maintain sound working relationships with partners and customers.Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.Requirements
Advanced degree in life sciences5-7 years of experience in biotechnology, analytics or pharmaceutical technology. Knowledge of the current gene editing and allogeneic technology is required. Ability to critically evaluate data from a broad range of scientific disciplines.At least 2-3 years of experience in CMC regulatory affairs supporting early and late-stage allogeneic gene-edited product development.Solid knowledge of regulatory submission procedures including CMC requirements for filing and maintaining INDs and IMPDs.Proven track record to successfully support IND/IMPD filing and late stage allogeneic gene-edited product development.Proven track record to successfully work in interdisciplinary teams, planning, and coordinating.Effective planning, organizational and interpersonal skills.Good technical writing skills.#LI-JK1#LI-HyrbidLegend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug-free workplace.Accepted file types: pdf, doc, docx, txt, rtfAccepted file types: pdf, doc, docx, txt, rtfAre you authorized to work lawfully in the United States? *
Select...Will you now or in the future require sponsorship for employment visa status (e.g., H-1B visa status)? *
Select...Were you referred by an internal employee of Legend Biotech?
*
Select...If referred by an internal employee of Legend Biotech, please list their name.How did you hear about us? *
Select...Permanent Address *Are you open to relocation? *
Select...Current/Most Recent Employer *Current/Most Recent Title *What is your desired salary? *Are you a relative of any employee at Legend Biotech? *
Select...If you are a relative to an employee at Legend Biotech, please list their name.Preferred First NameLinkedIn ProfileVoluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.As set forth in Legend Biotech US’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.Select...Voluntary Self-Identification of Disability
Form CC-305Page 1 of 1OMB Control Number 1250-0005Expires 04/30/2026Voluntary Self-Identification of Disability
Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to:Alcohol or other substance use disorder (not currently using drugs illegally)Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDSBlind or low visionCancer (past or present)Cardiovascular or heart diseaseCeliac diseaseCerebral palsyDeaf or serious difficulty hearingDiabetesDisfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disordersEpilepsy or other seizure disorderGastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndromeIntellectual or developmental disabilityMental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSDMissing limbs or partially missing limbsMobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supportsNervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilitiesPartial or complete paralysis (any cause)Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysemaShort stature (dwarfism)Traumatic brain injury
Disability Status
Select...
PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
#J-18808-Ljbffr
Associate Director, Regulatory CMC as part of the
Regulatory Affairs team based in
Somerset, NJ.Key ResponsibilitiesServes as the regulatory CMC representative on core teams, develops and plans regulatory CMC submission strategy with a focus on allogeneic gene-edited products.Provides guidance to technical team members for the requirements, especially on the unique requirements on gene editing technologies and allogeneic therapies. Identify the required documentation to support global submissions and coordinate the delivery of approved technical source documents in accordance with project timelines.Provide guidance on allogeneic and gene-edited product development at the R&D phase.Coordinates and manages CMC regulatory submissions, applying CMC global regulatory strategies.Prepare briefing books for Health Authority meetings.Facilitate consistency within the CMC regulatory documentation by sharing experience and/or contributing to template maintenance.Establish and maintain sound working relationships with partners and customers.Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.Requirements
Advanced degree in life sciences5-7 years of experience in biotechnology, analytics or pharmaceutical technology. Knowledge of the current gene editing and allogeneic technology is required. Ability to critically evaluate data from a broad range of scientific disciplines.At least 2-3 years of experience in CMC regulatory affairs supporting early and late-stage allogeneic gene-edited product development.Solid knowledge of regulatory submission procedures including CMC requirements for filing and maintaining INDs and IMPDs.Proven track record to successfully support IND/IMPD filing and late stage allogeneic gene-edited product development.Proven track record to successfully work in interdisciplinary teams, planning, and coordinating.Effective planning, organizational and interpersonal skills.Good technical writing skills.#LI-JK1#LI-HyrbidLegend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.Legend Biotech maintains a drug-free workplace.Accepted file types: pdf, doc, docx, txt, rtfAccepted file types: pdf, doc, docx, txt, rtfAre you authorized to work lawfully in the United States? *
Select...Will you now or in the future require sponsorship for employment visa status (e.g., H-1B visa status)? *
Select...Were you referred by an internal employee of Legend Biotech?
*
Select...If referred by an internal employee of Legend Biotech, please list their name.How did you hear about us? *
Select...Permanent Address *Are you open to relocation? *
Select...Current/Most Recent Employer *Current/Most Recent Title *What is your desired salary? *Are you a relative of any employee at Legend Biotech? *
Select...If you are a relative to an employee at Legend Biotech, please list their name.Preferred First NameLinkedIn ProfileVoluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.As set forth in Legend Biotech US’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.Select...Voluntary Self-Identification of Disability
Form CC-305Page 1 of 1OMB Control Number 1250-0005Expires 04/30/2026Voluntary Self-Identification of Disability
Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to:Alcohol or other substance use disorder (not currently using drugs illegally)Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDSBlind or low visionCancer (past or present)Cardiovascular or heart diseaseCeliac diseaseCerebral palsyDeaf or serious difficulty hearingDiabetesDisfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disordersEpilepsy or other seizure disorderGastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndromeIntellectual or developmental disabilityMental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSDMissing limbs or partially missing limbsMobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supportsNervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilitiesPartial or complete paralysis (any cause)Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysemaShort stature (dwarfism)Traumatic brain injury
Disability Status
Select...
PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
#J-18808-Ljbffr