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Senior Director Regulatory Affairs

Company: CASSS
Location: Newton
Posted on: September 12, 2020

Job Description:

Position Title: Senior Director Regulatory Affairs

Position Summary: As our lead regulatory strategist, the Senior Director, Regulatory Affairs will develop and implement global regulatory strategies in support of business objectives and will ensure regulatory compliance with pre-and-post approval filing and reporting requirements.

Responsibilities:

Working in partnership with cross-functional colleagues, the Sr. Director Regulatory Affairs will: Develop and implement global regulatory strategies in support of business objectives

Ensure regulatory compliance with pre- and post-approval filing and reporting requirements

Represent RA at external meetings with FDA and other global health authorities

Provide regulatory expertise and support for pre-clinical, CMC, and clinical areas for investigational products

Lead NDA efforts; provide global strategic regulatory guidance to project teams

Ensure clinical, non-clinical, and CMC programs are designed and implemented to meet regulatory requirements

Define regulatory expectations for program teams

Develop strategies and drafts and/or reviews responses and other documents intended for submission to FDA and other global health authorities

Serve as primary liaison with FDA, and other global regulatory authorities.

Review and interpret regulatory rules and guidance as they relate to company products and procedures

Ensure that content of regulatory dossiers meet format and content requirements applicable to specific health authority regulatory requirements

Manage, or delegate the management of, the completion of documents and other assigned tasks within established timelines and with high quality - in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory guidelines, styles, and processes

Lead the regulatory dossier submission process for Clinical Trial Applications (US, EU, Canada, etc.) and registration submission. Oversee the management of timelines, as needed, in conjunction with internal and/or external project management

Provide overall leadership for the development of global regulatory submission documents

Manage, review, and/or edit and ensure the quality of regulatory documents or sections of regulatory documents prepared by other writers (internal or external), ensuring adherence to standards

Serve as primary author for key regulatory documents or sections of regulatory documents (primarily briefing documents, meeting requests, and specialty submission documents)

Take initiative to suggest modifications to existing programs/plans and offer new ideas for the organization

Recruit, train, coach, and supervise staff (as needed) and provide oversight for regulatory consultants and contractors

Support or lead non-project activities, as needed (ie, SOP/standards development, organizational initiatives)

Excellent verbal and written communication skills; ability to collaboratively influence across multiple functions within a matrix environment

Strong negotiation and facilitation skills; ability to communicate sound regulatory advice based on regulations, as well as the business needs

Demonstrated ability to apply knowledge strategically and operationally across projects

Self-motivated and detail oriented with sound judgement and problem-solving skills

Ability to multi-task in a fast-paced environment with changing priorities

Ability to work independently as well as part of a team

Requirements

Requirements:

Bachelor of Science degree and 7 years’ regulatory affairs experience or Masters’ Degree in Regulatory Affairs and 5 years’ regulatory affairs experience within the biotech or pharmaceutical industry Knowledge of global (US, EU, ROW, ICH, etc.) regulatory requirements

Experience working on rare disease and ophthalmology programs, as well as recent successful NDA submission experience is preferred

Job Information

Job ID: 54336174

Location:

Newton, Massachusetts, United States

Position Title: Senior Director Regulatory Affairs

Company Name: Stealth BioTherapeutics

Job Function: Regulatory

Job Type: Full-Time

Job Duration: Indefinite

Min Education: BA/BS/Undergraduate

Min Experience: 7-10 Years

Required Travel: 10-25%

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Keywords: CASSS, Newton , Senior Director Regulatory Affairs, Other , Newton, Massachusetts

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