Director, Regulatory Affairs

Pennsylvaniafull time

On Site

senior

H1B: yes

Clinchoice Director, Regulatory Affairs at Clinchoice leads regulatory affairs function for pharmaceuticals and biotech in North America. Provides strategic and tactical leadership, manages client interactions, and ensures compliance with government regulations and industry guidelines.

Responsibilities

As the Director of Regulatory Affairs for Pharmaceuticals & Biotech, you will have the opportunity to formulate and implement strategies to support multiple leading clients for various regulatory activities. The ideal candidate is a go-getter, exceptional communicator, and strategic thinker who thrives in a fast-paced environment with multiple demands and quickly becomes a trusted partner to their peers and clients alike.
Provide strategic and tactical leadership of the regulatory affairs function in North America, in close collaboration with cross functional teams.
Lead client interactions and act as Subject Matter Expert on Regulatory projects for the biopharma clients.
Ensure compliance with all appropriate government regulations, industry guidelines, and best practices.
In collaboration with regulatory colleagues globally, devise and implement global regulatory strategy and provide leadership oversight for clients’ projects.
Manage, oversee and/or prepare regulatory documents and submissions in accordance with clients’ requirements.
Act as SME with deep knowledge of HA regulations for all aspects of biopharmaceutical regulations.
Collaborate with internal staff to author and compile documents for submission to regulatory agencies, including INDs, CTAs, BLAs, MAAs, and NDAs.
Mentor internal team across various regulatory projects.
Monitor Regulatory environment and communicate any changes and impact assessments to all team members.
Monitor regulatory landscape and communicate to senior leadership any impacts of guidelines and policies that can create business opportunities for the organization.
Hire, develop and mentor regulatory personnel and future regulatory staff.

Qualification

Bachelor’s degree in a scientific fieldAdvanced degree such as PharmD

Required

Bachelor’s degree in a scientific field
Eight or more years of experience in Regulatory Affairs for biopharmaceutical products
Experience developing regulatory strategies for INDs, CTAs, NDAs, MAAs and/or BLAs
Direct experience working with FDA and other health authorities

Preferred

Advanced degree such as PharmD, PhD, MS
Experience with Phase 1 through Phase III products
Experience with CBER and global biologics

Company

Clinchoice

View company page

Source: greenhouse

Active within the past hour

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Director, Regulatory Affairs at Clinchoice · LumiJobs