Dennis Partners · 8 hours ago
Regulatory Strategy Manager
Greater Boston
Full-time
Hybrid
Mid, Senior Level
$130K/yr - $180K/yr
4+ years expDennis Partners is committed to developing and commercializing innovative therapeutics to improve the lives of patients with serious retinal diseases. They are seeking a Regulatory Strategy Manager to support global regulatory activities for their investigational products, including preparing regulatory submissions and collaborating with cross-functional teams.
BiotechnologyConsultingHuman ResourcesRecruitingStaffing Agency
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
Qualification
Required
Bachelor degree in a scientific discipline
4+ years of Regulatory Affairs experience for pharmaceutical drugs
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
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
Preferred
Advanced degree (MS, PharmD or PhD)
Ophthalmology and/or Retinal disease experience
Experience with NDA support (preparation, submission and/or management)
Experience with small molecules and drug-led-device combination products
Experience in ex-US Clinical Trial Authorization Applications
Experience with eCTD and using Regulatory Information Management Systems
Working knowledge of eCTD elements and structure, ICH standards and submission requirements
Benefits
Annual target bonus
Equity
Comprehensive benefits
Company
Dennis Partners
Dennis Partners specializes in regulatory recruiting for the biotech and pharmaceutical industries.
2-10 employees
Funding
Current Stage
Early StageLeadership Team
Jilma Sweeney
President
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