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VP Regulatory Affairs

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

Job Description:

Company: Stratacuity: Proven Scientific Placement

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Our client in early stage development has an excitingoncology-focused platform and is seeking a Head of RegulatoryAffairs responsible for leading the Company's global regulatorystrategy, submissions and activities across all developmentprograms, while partnering with other key stakeholders. Thesuccessful candidate will have significant experience and a trackrecord of leading regulatory activities in support of marketingapproval for small molecule/precision medicine cancer therapeuticson accelerated timelines.

Primary Job Responsibilities:

Ensures global regulatory plans support a precision medicineapproach (integrated drug/diagnostic regulatory and submissionplans), including engagement plans and mitigation strategies forregulatory agencies.

Manages the preparation of IND submissions and marketingapplications to the FDA and other global regulatory agencies forprecision cancer medicines and companion diagnostic tests.

Provides innovative approaches to resolve complex regulatoryissues and increase speed to patients.

Manages on-going regulatory submission and reportingrequirements.

Builds and manages a team to support regulatory activitiesacross programs and electronic submissions.

Provides guidance and recommendations to key stakeholders withinthe organization and monitors compliance with regulatoryrequirements and commitments.

Provide strategic input on key development documents, clinicalprotocols, study reports, IBs, INDs, NDAs, and labeling for drugand diagnostic products.

Acts as primary regulatory contact with the FDA, internationalregulatory agencies and other regulatory bodies.

Provides regulatory oversight for product development,manufacturing and distribution.

Provides overall review, day-to-day management and operationalsuccess for all regulatory functions including the successfulintegration of activities cross-functionally.

Primary Job Requirements:

PharmD or PhD preferred; Bachelor’s degree required

15+ years’ experience in regulatory affairs, including in smallor mid-sized biopharmaceutical company

Oncology experience required, including with smallmolecules/precision medicine clinical programs; experience withCDRH and the development of companion diagnostics is highlydesired

At least five years' experience in managing a regulatoryteam

Proven ability in leading and directing regulatory affairsactivities from IND through NDA/MAA

Direct experience in developing strategy and leading teamsthrough interactions with health authorities

Track records of issue resolutions with main regulatoryauthorities; demonstrated ability to break down complex, scientificcontent into logical components

About Stratacuity:

Whether you are seeking a career change or simply interested inbecoming part of our network, you will appreciate the ethicsguiding each Stratacuity team member. We build lastingrelationships with exceptional biopharmaceutical talent and takegreat care to protect your personal information. Upon receivingyour inquiry, you may be directly contacted by a Stratacuity teammember to discuss your career goals. We will not share yourinformation with anyone without your direct prior consent.

Stratacuity is an Equal Employment Opportunity/AffirmativeAction Employer. All qualified applicants will receiveconsideration for employment without regard to race, color,religion, sex, age, sexual orientation, gender identity, nationalorigin, disability, protected veteran status, or any othercharacteristic protected by law. Stratacuity will considerqualified applicants with criminal histories in a manner consistentwith the requirements of applicable law. If you have visited ourwebsite in search of information on employment opportunities or toapply for a position, and you require an accommodation in using ourwebsite for a search or application, please contact us.

Apex Systems is an equal opportunity employer. We do notdiscriminate or allow discrimination on the basis of race, color,religion, creed, sex (including pregnancy, childbirth,breastfeeding, or related medical conditions), age, sexualorientation, gender identity, national origin, ancestry,citizenship, genetic information, registered domestic partnerstatus, marital status, disability, status as a crime victim,protected veteran status, political affiliation, union membership,or any other characteristic protected by law. Apex will considerqualified applicants with criminal histories in a manner consistentwith the requirements of applicable law. If you have visited ourwebsite in search of information on employment opportunities or toapply for a position, and you require an accommodation in using ourwebsite for a search or application, please contact our EmployeeServices Department at employeeservices@apexsystemsinc.com or844-463-6178.

Apex Systems dba Stratacuity, is an equal opportunity employer.We do not discriminate or allow discrimination on the basis ofrace, color, religion, creed, sex (including pregnancy, childbirth,breastfeeding, or related medical conditions), age, sexualorientation, gender identity, national origin, ancestry,citizenship, genetic information, registered domestic partnerstatus, marital status, disability, status as a crime victim,protected veteran status, political affiliation, union membership,or any other characteristic protected by law. Stratacuity willconsider qualified applicants with criminal histories in a mannerconsistent with the requirements of applicable law.

Keywords: Stratacuity: Proven Scientific Placement, Waltham , VP Regulatory Affairs, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , VP Regulatory Affairs, Other , Cambridge, Massachusetts

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