LexingtonRecruiter Since 2001
the smart solution for Lexington jobs

Associate Director/Director Regulatory Affairs CMC - Lexington, MA, US

Company: Translate Bio
Location: Lexington
Posted on: August 16, 2019

Job Description:

Job Summary The Associate Director/Director of Regulatory Affairs CMC will be responsible for supporting development programs providing CMC expertise and leadership including review for CMC regulatory submissions to U.S. and European health authorities. Working closely with the CMC team and the Program Teams, the Associate Director/Director will develop a global regulatory CMC strategy in support of all development programs. Job Responsibilities

  • Work closely with CMC team and program teams to develop CMC regulatory submission strategies, prepare and review content, and maintain submission timelines to successfully meet program and company objectives
  • Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines
  • Lead coordination efforts for CMC content of original INDs, IND amendments, investigational medicinal product dossiers (IMPD), development safety update reports and BLA's/MAA's
  • Liaise with health authorities and lead preparations for health authority meetings with CMC focus
  • Establish, manage and maintain a knowledge base of current and emerging CMC regulatory requirements and guidelines in the CMC field
  • Ensure that CMC-related changes are reported in a timely manner to health authorities in accordance with regulatory requirements
  • Assume additional responsibilities as assigned to supplement efforts outside of CMC focus (Orphan Drug Applications, Advanced Therapy Medicinal Product Classifications, etc.) Required Skills & Qualifications
    • Bachelor's degree in life sciences required; advanced degree preferred
    • Minimum of 10 years in Regulatory Affairs (CMC) with a B.S./B.A., or 8 years with M.S. or Ph.D.
    • Knowledge of drug development, with strong preference for large molecule/biologics experience
    • Excellent knowledge of U.S., EU and ICH requirements and guidelines, with experience as regulatory authority liaison
    • Experience with gene therapy products and advanced therapy medicinal products very desirable
    • Ability to work effectively as a leader with a proven track record of effective collaboration as part of cross functional program teams
    • Excellent written and oral communication skills
    • Excellent interpersonal and negotiation skills with strong ability to develop effective relationships with key stakeholders
    • Strong ability to multi-task, set priorities, and meet timelines in an innovative small company environment
    • Ability to analyze complex issues and to develop proactive recommendations that translate strategy into action
    • Some domestic and international travel required

Keywords: Translate Bio, Lexington , Associate Director/Director Regulatory Affairs CMC - Lexington, MA, US, Executive , Lexington, Kentucky

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Space Planning Director
Description: Job TitleSpace Planning DirectorJob Description SummaryWith account and/or client leadership, ensures that all Space Management deliverables are met including SLA and KPI requirements. Assists in defining (more...)
Company: Cushman & Wakefield
Location: Louisville
Posted on: 08/24/2019

Director, Media Account Manager / P
Description: The intersection of media commerce is a creating new opportunities for advertisers to drive demand grow share. Kroger Precision Marketing leverages rich 1P data to target messages, bridge advertising (more...)
Company: 84.51--
Location: Cincinnati
Posted on: 08/24/2019

VP Sales Kroger Advertising
Description: VP SALES, KROGER ADVERTISING - CINCINNATI, OH / CHICAGO, IL br br ABOUT US br br Join an entrepreneurial, dynamic and fun team as we build businesses across brands you know and love, and the Kroger (more...)
Company: 84.51--
Location: Cincinnati
Posted on: 08/24/2019

Sales and Operations Management Trainee
Description: Position Summary: Take charge. Think fast. Move forward. As a Sales and Operations Management Trainee in our fast-paced environment, you will use your hard-earned degree to run a business and quickly (more...)
Company: Penske
Location: Louisville
Posted on: 08/24/2019

Merchandise Ops Leader (Department Manager)
Description: If you're both an animal lover and a people person, a position in one of our stores might be a great fit. We're looking for people with a strong commitment to helping pets and their parents experience (more...)
Company: Petco
Location: Louisville
Posted on: 08/24/2019

Director of Retail Operations - Own a Franchise
Description: Directors of Retail Operations:
Company: CMP.jobs
Location: Louisville
Posted on: 08/24/2019

Project Manager - PCA
Description: SUMMARY br br Partner Engineering and Science, Inc. is looking to hire a full-time Project Manager - PCA to work in our Cincinnati, OH office to assist our building science group. The person will (more...)
Company: Partner Engineering and Science
Location: Cincinnati
Posted on: 08/24/2019

Project Manager
Description: 16 years of experience in IT industry with at least 6 years in Project/Program management. Experience on scheduling, budgeting, project management tools, clarity, cost plans, CR management,
Company: Samurai Infotech
Location: Louisville
Posted on: 08/24/2019

Strategic Accounts Director
Description: Strategic Accounts Director The Strategic Accounts Director is responsible for Regional Enterprise Large Account Sales and Account Management. As a Strategic Accounts Director on the field sales team, (more...)
Company: Group A LLC
Location: Cincinnati
Posted on: 08/24/2019

Enterprise Relationship Manager
Description: Requisition Number 12733 Location s Cincinnati,Ohio Position Type Full-time Shift First Eligible for Relocation No Job Description The Company Worldpay is a global payments leader powering international (more...)
Company: Vantiv
Location: Cincinnati
Posted on: 08/24/2019

Log In or Create An Account

Get the latest Kentucky jobs by following @recnetKY on Twitter!

Lexington RSS job feeds