Associate Director/Director, Regulatory Affairs

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Associate Director/Director, Regulatory Affairs Company: Public Affairs Council

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Associate Director/Director, Regulatory Affairs Cambridge,MA

Company Overview

Fulcrum Therapeutics is a clinical-stage biopharmaceuticalcompany focused on improving the lives of patients with geneticallydefined diseases in areas of high unmet medical need. Fulcrum’sproprietary patient-focused product engine is designed tosystematically identify and validate cellular drug targets that canmodulate gene expression to treat the root cause of geneticallydefined rare diseases.

Description

Reporting to and in partnership with the Senior Vice Presidentof Regulatory Affairs and Quality Assurance, this position will beresponsible for developing, implementing, and advising on domesticand global regulatory strategies for development programs to secureand maintain market access for product(s) in line with businessobjectives, and in coordination with key internal stakeholders.This individual will manage regulatory aspects of compounds throughall phases of development, post-approval, and life cycle of theproduct.

Responsibilities

Liaise and collaborate with external CRO and Fulcrum teams toset up investigational trial applications in and outside of theUS.

Provides high level strategic and operational regulatorydirection on projects both domestically and globally.

Uses extensive knowledge of US, EU and ICH regulatoryrequirements to support project objectives and business goals.

Oversees the preparation and submission of documentation tosupport investigational and registration packages throughout theworld and ensures timelines are met.

Reviews sections of IND/CTA, NDA/MAA, and other globalsubmission documents in support of clinical trials, and theiramendments in conformance with local regulatory requirements.

Liaises with FDA and partners with CRO’s (ex-US) to navigateregulatory communications and strategies.

Maintains awareness of global regulatory environment andregulatory precedents to assess potential impact on productdevelopment programs.

Builds partnerships with stakeholders from other functions toensure that strategic business goals are met through the sharing ofknowledge and expertise.

Regulatory representative on the program team for assignedproducts.

Qualifications

At least 10 years of Drug Discovery experience, 5-7 years’experience in Regulatory Affairs.

Strong strategic skills and the ability to thrive in a dynamicsmall-team environment with a willingness to perform additionaltasks outside of the duties listed above.

Experience with electronic regulatory submission software andsystems, IND/CTA/NDA/MAA submissions, eCTD format.

Rare Disease experience preferred but not required.

Able to successfully manage and prioritize complex projects todeadlines with relative independence; organized and adaptable toaddress conflicting deadlines in a dynamic drug developmentenvironment.

Demonstrated attention to detail and follow-through on assignedactivities.

Outstanding interpersonal and communication (written and verbal)skills; demonstrates calm, professional, diplomatic and positivebehaviors.

Committed to working alongside cross-functional colleagues aspart of highly functioning teams.

Strong computer skills and highly proficient in MS Officeapplications and Adobe Acrobat.

Keywords: Public Affairs Council, Cambridge , Associate Director/Director, Regulatory Affairs, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Associate Director/Director, Regulatory Affairs, Other , Cambridge, Massachusetts