Posted on: April 20, 2021
Job Number: JN -042021-62891
Title: Associate Director
Location: 100% Remote
Job Type: Long Term Contract
- Responsibilities include actively leading the development and implementation of CMC regulatory strategy for specific gene therapy programs, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing regulatory CMC leadership on the cross functional sub teams for the assigned program.
- The role is also responsible to support the evaluation of business development activities including due diligence.
- The CMC GRL provides regulatory CMC leadership on the cross functional sub teams (regulatory science project teams, asset teams) and advises on best practices and/or supports PDCs.
- This candidate must have proven leadership and abilities to work cross-functionally and across cultures.
- Strong communication, regulatory CMC knowledge and interpersonal skills are required.
- At least 10+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 7+ years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
- Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new biological, oligonucleotide, and/or chemical entities
- Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions.
- Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics
- Knowledge of global guidance, regulations and ICH/GMP requirements
- Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure
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