Agenus

Director, Regulatory Strategy CMC

US-CA-Berkeley
Job ID
2017-1321
Category
Regulatory

Overview

The Director will joint motivated and newly formed Regulatory Science & Pharmaco-vigilance (RSP) business unit aiming at brining regulatory innovation in drug development and commercialization.

 

The RSP aims to maximize opportunities for product approval, its safe use and further development by:

 

  • Leading global regulatory strategies that allow drug and CMC development efforts to achieve a faster regulatory approval, optimal product label and support commercial success
  • Delivering regulatory milestones and timely registration throughout the product lifecycle
  • Ensuring patient safety by early identification of safety signals, building robust PhV systems and preparing for post-marketing commitments
  • Proactively influencing and engaging with healthcare environment and regulatory policy framework to facilitating approval and market penetration

 

The director regulatory strategy CMC is responsible for overseeing the development and implementation of global regulatory CMC strategies for product development and commercialization. He/she will provide regulatory CMC leadership across projects, teams and committees and will provide strategic and operational leadership for regulatory CMC activities including submission applications and health authority interactions.

 

The position reports to the Vice President of Regulatory Science & Pharmaco-vigilance business unit.

Responsibilities

  • Design, develop, and implement regulatory CMC strategy across projects
  • Deliver regulatory strategy objectives for global regulatory CMC, including operational risk management
  • Lead and manage regulatory CMC cross-functional team members
  • Work collaboratively across functions and teams to develop and implement regulatory CMC strategies as aligned across the business
  • Develop and maintain relationships with health authorities and respond to health agencies, as needed.
  • Provide regulatory CMC expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent
  • Recognized internally and externally as an expert in regulations, guidelines and precedents related to pharmaceutical development and CMC lifecycle management

Qualifications

  • Advanced degree in a scientific discipline, preferably PhD or PharmD
  • 12+ years of industry experience in pharmaceutical or biotech company
  • 8+ years of experience working in regulatory affairs CMC including managing post-approval changes for commercial products
  • Proficiency in regulatory (FDA, EMA, and ICH) guidelines
  • Strong knowledge of current Good Manufacturing Practices (cGMP) and establishment registration requirements
  • Experience in leading and writing CMC submissions is required
  • Experience with post approval management of Quality by Design (QbD) filings, as well as experience with global filings highly desirable
  • Sound understanding of CMC and QA-related issues

 

Core Competencies

 

  • Strategic thinking and strong problem-solving skills
  • Strong interpersonal skills and the ability to communicate effectively with cross-functional teams
  • Strong oral and written communication skills
  • Strong sense of planning and prioritization, and the ability to work with all levels of management
  • Proven ability to work with interdisciplinary teams
  • Fluency in English, written and spoken - knowledge of other languages valuable

 

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