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Who are we?
We Are PRA.
We are 20,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting life saving drugs into the hands of those who need them most.
What you Need (Qualifications)
- Advanced degree in a scientific discipline -PhD or Master’s degree preferred
- Bachelor’s degree in relevant field of study required
- 15 + years relevant experience required
- 8+ years of pharmaceutical industry experience
- 6+ years of experience working in related regulatory affairs CMC
- Experience in cell and/or gene therapy and device experience preferred
- Proficiency in regulatory (FDA, EMA, Health Canada, ICH) guidelines
- Experience in leading CMC submission preparation and Health Authority interactions
- Strategic thinking and strong problem-solving skills
- Strong interpersonal skills and the ability to communicate effectively cross-functionally
- Strong oral and written communication skills
- Sound understanding of CMC and GMP related issues.
- Strong sense of planning and prioritization, and the ability to work with all levels of management
- Proven ability to work with interdisciplinary teams and dealing with unfamiliar situations
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa statusPRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
The Director is responsible for overseeing the development and implementation of global regulatory CMC strategies for assigned cell and/or gene therapy products, including combination products with devices. The Director will provide strategic and operational leadership for regulatory CMC activities including submissions, reviews, and health authority interactions. Key Responsibilities
- Design, develop, and implement regulatory CMC strategy for assigned cell and/or gene therapy projects
- Work collaboratively across functions and teams to develop and implement regulatory CMC strategies
- Develop and maintain relationships with health authorities and lead the preparation of health authority interactions
- Develop regulatory strategies integrated with cross-functional project teams to facilitate timely submissions and approvals
- Provide regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent
- Develop/assess project plans and timelines and assign and manage team effectively to ensure projects are appropriately prioritized and goals are met
- Recognized internally and externally as an expert in cell and gene therapy regulations, guidelines and precedents related to pharmaceutical development