Associate Director, Regulatory Affairs and Submissions @220 Altasciences Company Inc

[Hiring] Associate Director, Regulatory Affairs and Submissions @220 Altasciences Company Inc

Mar 11, 2025 - 220 Altasciences Company Inc is hiring a remote Associate Director, Regulatory Affairs and Submissions. 💸 Salary: $101,485 - $155,000 yearly. 📍Location: USA.

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Role Description

The Associate Director, Regulatory Affairs and Submissions, is responsible for:

Providing regulatory guidance to Sponsors related to drug development and submission requirements
Leading the initiation (requests), preparation (meeting packages), and conduct of a variety of Agency interactions (Type A – C, INTERACT meetings)
Leading regulatory submission preparation (including assessing for gaps in requirements) and filing activities, as assigned
Assisting with coordination of team workload and/or supervising staff on a project by project basis

This position is 100% REMOTE.

What You’ll Do Here

Work closely with business development team and sponsors to understand sponsor’s needs and interests, and to provide regulatory guidance related to drug development and submission preparation
Interact with sponsors as a regulatory consultant to build trust and encourage engagement
Evaluate, develop, plan and prepare regulatory strategy and submissions (INDs primarily) for new drugs under development with the collaboration of multiple cross-functional teams
Provide critical review of key Health Authority submissions such as pre-IND, IND, meeting requests, briefing documents and response documents
Perform gap analysis for drug development programs and to inform regulatory strategies including advising on core CMC development plans
Interpret laws and regulations (FDA, Health Canada, ICH, EMA, and MHRA)
Lead, manage and prepare clinical trial submissions
Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies
Communicate, consult and negotiate with health authorities
Respond in a timely manner to health authority requests
Resolve issues in a timely manner
Participate in sponsor’s audits and regulatory inspections
Provide regulatory input into client-provided proposals
Maintain a positive, result orientated work environment, build partnerships with cross-functional teams/departments, maintain a positive team-based culture
Support business development for proposals and costing; support bid defense meetings
Participate in the development of standard operating procedures (SOPs)
Coordinate with internal teams to deliver high-quality documents in accordance with agreed upon timelines
Conduct all work in compliance with SOPs, Good Clinical Practice (GCP), and all regulatory guidelines
Participate in departmental or interdepartmental quality improvement initiatives
Train and mentor other team members
Maintain and participate in the objectives of the department
Other duties as assigned

Qualifications

BSc/MSc in a relevant field
7+ years of predominantly US regulatory experience in an industry setting
Strong knowledge of drug development and regulatory policy including ICH, FDA, and Health Canada guidelines related to early phase drug development
Demonstrated experience with leading IND submissions in US, experience with other regulatory agencies an asset
Knowledge of CMC drug development requirements is an asset
Ability to assess nonclinical data for gaps in an IND-enabling package
Leadership skills
Excellent verbal and written communication skills
Critical thinking skills and ability to acquire and apply knowledge quickly
Professional attitude and strong interpersonal skills
Ability to work well with a multi-disciplinary team of professionals
Client-focused approach to work
Flexible attitude with respect to work assignments and new learning
Ability to prioritize workload
Thorough understanding of clinical research, drug development process and applicable regulatory guidance
Strong computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems

Benefits

Health/Dental/Vision Insurance Plans
401(k)/RRSP with Employer Match
Paid Vacation and Holidays
Paid Sick and Bereavement Leave
Employee Assistance & Telehealth Programs
Telework when applicable

Training & Development Programs
Employee Referral Bonus Program
Annual Performance Reviews

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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Associate Director, Regulatory Affairs and Submissions @220 Altasciences Company Inc

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Salary 💸 $101,485 - $155,000 yearly	Remote Location USA
Job Type full-time	Posted Mar 11, 2025

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📍	Be aware of the location restriction for this remote position: USA
‼	Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more.

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[Hiring] Associate Director, Regulatory Affairs and Submissions @220 Altasciences Company Inc

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