Sr. Manager, Regulatory Affairs
Description:
About Us:
We are Larimar Therapeutics, based in the Philadelphia area, and committed to discovering and developing therapeutics to dramatically improve the lives of patients with complex rare diseases.
At Larimar, we embrace everyone's contribution to our Mission.
Our values connect us and ensure we communicate openly, treat each other with respect, help us grow from our successes and failures, and innovate.
If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you!We are a clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.
Our lead product candidate, CTI-1601, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia.
Friedreich's ataxia is a rare, progressive and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.
We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and about 40 employees.
Our management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs and the development of manufacturing processes utilizing good manufacturing practices (GMPs).
Our strategy is to become a leader in the treatment of rare diseases by leveraging our technology platform and applying the team's know how and expertise to the development of CTI-1601 and other future pipeline programs.
Position
Summary:
Larimar is seeking a Senior Manager, Regulatory Affairs, to support the global regulatory strategy, regulatory activities and regulatory operations for products in development.
The Senior Regulatory Affairs Manager will be a key member of project teams.
The role reports to the Senior Director of Regulatory Affairs.
Job Duties/
Responsibilities:
Responsible for regulatory activities in support of development, review and submission of high quality global regulatory dossiers as required to support global health authority interactions and global clinical trials, including meeting packages, initial INDs/IND amendments, CTA's, IMPDs, annual reports, etc.
Interface with other Larimar departments and outside consultants via project team meeting participation to ensure deliverables from contributing departments are compliant and received according to project timelines.
Establish, manage, and maintain knowledge of current and emerging global regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to the Larimar regulatory team and other departments.
Advise other departments on regulatory health authority requirements for product development and regulatory submissions Lead or support the generation or revision of SOPs related to regulatory affairs Serve as back up to Regulatory Operations for filing global regulatory submissions (prior knowledge of Reg Ops is not required).
Requirements:
Minimum of 4-year undergraduate degree 4
years' experience in a Regulatory Affairs role in the pharmaceutical industry Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies.
Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to original INDs, IND amendments, CTA submissions and global Health Authority Meeting packages and global marketing authorization applications.
Excellent communication, time management and project management skills Continuous quality improvement mindset and attention to details Can do attitude, flexibility, and mental agility Equal Opportunity EmploymentWe are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner.
We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.
PI97f9c3ef2d89-31181-33254396 Recommended Skills Agility Attention To Detail Clinical Trials Clinical Works Communication Continuous Quality Improvement (Cqi) Apply to this job.
Think you're the perfect candidate? Apply on company site $('.
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on('click', function (event) window.
ExternalApply = window.
open('/interstitial?jobdid=j3r6065wz78llq74b10', 'ExternalApply-j3r6065wz78llq74b10'); ); Estimated Salary: $20 to $28 per hour based on qualifications.
About Us:
We are Larimar Therapeutics, based in the Philadelphia area, and committed to discovering and developing therapeutics to dramatically improve the lives of patients with complex rare diseases.
At Larimar, we embrace everyone's contribution to our Mission.
Our values connect us and ensure we communicate openly, treat each other with respect, help us grow from our successes and failures, and innovate.
If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you!We are a clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.
Our lead product candidate, CTI-1601, is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia.
Friedreich's ataxia is a rare, progressive and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.
We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and about 40 employees.
Our management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs and the development of manufacturing processes utilizing good manufacturing practices (GMPs).
Our strategy is to become a leader in the treatment of rare diseases by leveraging our technology platform and applying the team's know how and expertise to the development of CTI-1601 and other future pipeline programs.
Position
Summary:
Larimar is seeking a Senior Manager, Regulatory Affairs, to support the global regulatory strategy, regulatory activities and regulatory operations for products in development.
The Senior Regulatory Affairs Manager will be a key member of project teams.
The role reports to the Senior Director of Regulatory Affairs.
Job Duties/
Responsibilities:
Responsible for regulatory activities in support of development, review and submission of high quality global regulatory dossiers as required to support global health authority interactions and global clinical trials, including meeting packages, initial INDs/IND amendments, CTA's, IMPDs, annual reports, etc.
Interface with other Larimar departments and outside consultants via project team meeting participation to ensure deliverables from contributing departments are compliant and received according to project timelines.
Establish, manage, and maintain knowledge of current and emerging global regulatory requirements, guidelines, and best practices, and interpret and communicate relevant issues to the Larimar regulatory team and other departments.
Advise other departments on regulatory health authority requirements for product development and regulatory submissions Lead or support the generation or revision of SOPs related to regulatory affairs Serve as back up to Regulatory Operations for filing global regulatory submissions (prior knowledge of Reg Ops is not required).
Requirements:
Minimum of 4-year undergraduate degree 4
years' experience in a Regulatory Affairs role in the pharmaceutical industry Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies.
Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to original INDs, IND amendments, CTA submissions and global Health Authority Meeting packages and global marketing authorization applications.
Excellent communication, time management and project management skills Continuous quality improvement mindset and attention to details Can do attitude, flexibility, and mental agility Equal Opportunity EmploymentWe are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner.
We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.
PI97f9c3ef2d89-31181-33254396 Recommended Skills Agility Attention To Detail Clinical Trials Clinical Works Communication Continuous Quality Improvement (Cqi) Apply to this job.
Think you're the perfect candidate? Apply on company site $('.
external-apply-email-saved').
on('click', function (event) window.
ExternalApply = window.
open('/interstitial?jobdid=j3r6065wz78llq74b10', 'ExternalApply-j3r6065wz78llq74b10'); ); Estimated Salary: $20 to $28 per hour based on qualifications.
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