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Regulatory Affairs (Sr. Manager/Associate Director) Jobs in Philadelphia, PA at Adaptimmune Therapeutics plc



Title: Regulatory Affairs (Sr. Manager/Associate Director)

Company: Adaptimmune Therapeutics plc

Location: Philadelphia, PA

Salary: $100K – $150K*

Category: Pharmaceuticals & Biotech

Job Description

PRIMARY RESPONSIBILITY

The Sr Manager/Associate Director of Regulatory Affairs is responsible for developing, implementing and leading short- and long-term global regulatory strategies that support the success of products throughout their lifecycle. Serves as the primary liaison to regulatory agencies and leads submission activities to regulatory agencies. Identifies and assesses regulations and guidance documents provides interpretive guidance applicable implementation. This position will work within cross-company development project teams and will provide regulatory expertise into strategic regulatory plans.

KEY RESPONSIBILITIES

Leads and defines the global regulatory strategy and executes regulatory strategies

Preparation and/or supervision of preparation of regulatory submissions including, INDs, CTAs, IDEs, amendments, annual reports, meeting briefing documents, responses to regulatory agency information requests, and marketing authorization applications

Serves as the primary liaison with FDA and other regulatory agencies throughout development of projects, including support for regulatory agency meetings and teleconferences

Identify and assess existing and new regulations, guidance documents, international standards, or consensus standards; and provide interpretive guidance and ensure applicable implementation into development planning and execution

Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation

Represents Global Regulatory Affairs as the primary contact on regulatory aspects of the projects and as a member of the cross-functional project team, providing regulatory guidance/strategy/perspective in team meetings and presentations at senior leadership governance meetings

Participate in due diligence activities on potential licensing, acquisition, or collobaration opportunities

Reviews and establishes standard operating procedures (SOPs) and global regulatory affairs processes

QUALIFICATIONS & EXPERIENCE

Bachelor’s Degree required; advanced degree preferred

At least 6 years of Global Regulatory Affairs experience

Must have experience filing regulatory dossiers (CTAs, INDs, IMPDs, IDEs)

Solid working knowledge of relevant domestic and global regulations and guidance

Experience in cell and gene therapy and/or oncology is preferred

Experience with BLAs/NDAs/MAAs preferred

Willing to travel domestically and internationally up to 15%

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Valid through: 6/22/2020

 

About Adaptimmune Therapeutics plc