In order to be successful in this role, you will have demonstrable multi-disciplinary experience gained within a Pharma, CRO or Biotech setting working on cell and gene therapies.
You are an experienced regulatory affairs CMC professional and you have lead CMC submission preparation and Health Authority interactions
You are seasoned in interactions with regulatory (FDA, EMA, Health Canada, ICH) guidelines
We are also seeking the following attributes
Proven leadership skills;
Ability to navigate complex projects and work under pressure;
A results and delivery focused approach;
Ability to effectively manage conflict and negotiations.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
ResponsibilitiesThe Role We are currently seeking a CMC Director of Cell and Gene Therapy to join our industry leading CMC group. This is an excellent and rare career opportunity for a seasoned clinical industry professional looking for a role where they can leverage their multi-disciplinary experience within a key and pioneering PRA Business Unit. 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. PRA understand that Cell and gene therapies are a transformative new category of medicines whose full potential is only just beginning to emerge and have the potential to address complex diseases, such as motor neurone disease, and many rare disorders for which there are no effective treatments. The Director will provide strategic and operational leadership for regulatory CMC activities including submissions, reviews, and health authority interactions in such a cutting edge area of the Pharma Industry. Working strategically to develop regulatory strategies integrated with cross-functional project teams to facilitate timely submissions and approvals key responsibilities will include:
Designing, developing, and implementing regulatory CMC strategy for assigned cell and/or gene therapy projects
Developing and maintaining relationships with health authorities and lead the preparation of health authority interactions
You will be recognized internally and externally as an expert in cell and gene therapy regulations, guidelines and precedents related to pharmaceutical development