Dennis Partners
Senior Manager or Manager, Regulatory Strategy
Dennis Partners, Oklahoma City, Oklahoma, United States
Our client is committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. They are seeking a Regulatory Strategy Senior Manager or Manager to support global regulatory activities for their investigational products. You will prepare Regulatory submissions (including INDs, IND/CTA/amendments, and Briefing Books), provide guidance to the team on regulatory responses, and support an upcoming NDA. This company offers excellent employee benefits and a science-based entrepreneurial culture that empowers curiosity. With their lead candidate currently in Phase 3 trials, now is an exciting time to join this growing organization!
Responsibilities
Assist the Senior Director, Regulatory Strategy in implementing regulatory strategy plans for ophthalmology programs, from development and throughout the life‑cycle of the dossier/product with the focus on nonclinical and clinical modules.
Work closely and collaboratively with other functions in the preparation of high‑quality, timely submissions to Regulatory Agencies. This is a ‘hands on’ position including, as needed: Review and proofreading of administrative forms, cover letters, general correspondence for appropriate formatting accuracy, and completeness;
Authoring health authority responses alongside subject matter experts;
Collaborating with cross‑functional teams through submission deliverables;
Support of submission activities for initial INDs, NDAs, amendments/ supplements, Clinical Trial Applications, meeting requests/briefing materials, and as appropriate, expedited program designation requests and Pediatric Study Plans.
Reviewing and proofreading the nonclinical and clinical content of submissions for regulatory acceptability, accuracy and completeness.
Preparing, reviewing or proofreading regulatory documents to clinical CROs requested for global clinical trial applications.
Coordinate with Regulatory Operations for submission planning of new applications, supplements or amendments and other regulatory filings in USA and outside US, as appropriate.
Work closely with the Sr. Director, Regulatory Strategy to prepare for US and ex‑US regulatory agency meetings.
Maintain working knowledge of the regulations and processes that govern the content and maintenance of documents required by the Health Authorities and ICH, and keeps up to date with the regulatory and competitor landscape.
Contribute to improvements in department best practices and SOPs.
Perform other duties as required, interfacing with other departments, CROs, and external vendors/consultants.
Archive and maintain regulatory submissions, correspondence and other regulatory documents in compliance with regulatory requirements and SOPs.
Qualifications
Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
4+ years of Regulatory Affairs experience for pharmaceutical drugs.
Ophthalmology and/or Retinal disease experience desired but not required.
Experience with preparation of INDs, amendments or supplements and Briefing Books.
Must be familiar with the requirements for IBs, clinical protocols and eCTD M1, M2.4, M2.5, M2.6, M2.7, M4 and M5.
Good working knowledge of FDA requirements for drugs.
Must have some experience responding to FDA queries and preparing for Health Authority meetings.
Experience with NDA support (preparation, submission and/or management) a plus.
Experience with small molecules and drug‑led‑device combination products a plus but not required.
Experience in ex‑US Clinical Trial Authorization Applications a plus.
Experience with eCTD and using Regulatory Information Management Systems.
Working knowledge of eCTD elements and structure, ICH standards and submission requirements.
Strong regulatory writing and communication skills.
Proficient in MS Word and Adobe Acrobat Pro applications and use of eCTD templates.
Ability to balance multiple tasks to meet priorities and timelines.
Must be comfortable in a small company environment. Able to be flexible and comfortable with ambiguity.
This is an onsite position in the Greater Boston Area (onsite 3 days per week). NOTE: Our client prefers candidates in the Greater Boston Area or those willing to relocate to the Boston area.
The budgeted salary range for this position is $130,000 to $180,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.
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Responsibilities
Assist the Senior Director, Regulatory Strategy in implementing regulatory strategy plans for ophthalmology programs, from development and throughout the life‑cycle of the dossier/product with the focus on nonclinical and clinical modules.
Work closely and collaboratively with other functions in the preparation of high‑quality, timely submissions to Regulatory Agencies. This is a ‘hands on’ position including, as needed: Review and proofreading of administrative forms, cover letters, general correspondence for appropriate formatting accuracy, and completeness;
Authoring health authority responses alongside subject matter experts;
Collaborating with cross‑functional teams through submission deliverables;
Support of submission activities for initial INDs, NDAs, amendments/ supplements, Clinical Trial Applications, meeting requests/briefing materials, and as appropriate, expedited program designation requests and Pediatric Study Plans.
Reviewing and proofreading the nonclinical and clinical content of submissions for regulatory acceptability, accuracy and completeness.
Preparing, reviewing or proofreading regulatory documents to clinical CROs requested for global clinical trial applications.
Coordinate with Regulatory Operations for submission planning of new applications, supplements or amendments and other regulatory filings in USA and outside US, as appropriate.
Work closely with the Sr. Director, Regulatory Strategy to prepare for US and ex‑US regulatory agency meetings.
Maintain working knowledge of the regulations and processes that govern the content and maintenance of documents required by the Health Authorities and ICH, and keeps up to date with the regulatory and competitor landscape.
Contribute to improvements in department best practices and SOPs.
Perform other duties as required, interfacing with other departments, CROs, and external vendors/consultants.
Archive and maintain regulatory submissions, correspondence and other regulatory documents in compliance with regulatory requirements and SOPs.
Qualifications
Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
4+ years of Regulatory Affairs experience for pharmaceutical drugs.
Ophthalmology and/or Retinal disease experience desired but not required.
Experience with preparation of INDs, amendments or supplements and Briefing Books.
Must be familiar with the requirements for IBs, clinical protocols and eCTD M1, M2.4, M2.5, M2.6, M2.7, M4 and M5.
Good working knowledge of FDA requirements for drugs.
Must have some experience responding to FDA queries and preparing for Health Authority meetings.
Experience with NDA support (preparation, submission and/or management) a plus.
Experience with small molecules and drug‑led‑device combination products a plus but not required.
Experience in ex‑US Clinical Trial Authorization Applications a plus.
Experience with eCTD and using Regulatory Information Management Systems.
Working knowledge of eCTD elements and structure, ICH standards and submission requirements.
Strong regulatory writing and communication skills.
Proficient in MS Word and Adobe Acrobat Pro applications and use of eCTD templates.
Ability to balance multiple tasks to meet priorities and timelines.
Must be comfortable in a small company environment. Able to be flexible and comfortable with ambiguity.
This is an onsite position in the Greater Boston Area (onsite 3 days per week). NOTE: Our client prefers candidates in the Greater Boston Area or those willing to relocate to the Boston area.
The budgeted salary range for this position is $130,000 to $180,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.
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