If you are looking to join a supportive team with a proven track record in drug discovery and development, and are as passionate as we are, we want to hear from you.
Based in Burnaby, BC or Cambridge, MA, the Associate Director, Regulatory Affairs will be responsible for coordinating the preparation and submission of filings to various regulatory authorities and for assisting with regulatory strategy development for Genevant Sciences.
Responsibilities will include:
Prepare or coordinate the preparation of submission documents such as CTA, IND, DSUR.
Provide guidance and support to product development teams on regulatory issues.
Provide input on regulatory strategy changes and seek and summarize changes in regulations.
Contribute to the development and realization of business, e.g. by assisting with the development of adequate regulatory strategies.
Establish standard practices to achieve efficiency within Regulatory Affairs, including interfacing with other departments and collaborators.
Provide input to the management team in establishing short and long-term business strategic plans and objectives. Direct implementation of business strategic plans to achieve objectives.
Responsible for participating in multidisciplinary teams of professionals (internal and external to Genevant) located mainly in North America (US and Canada), but also globally.
Other duties as assigned.
About your Application:
We value diversity and encourage applications from all qualified candidates.
Bachelor’s degree and a minimum of 8 years’ Regulatory Affairs experience in biotech/pharma, or equivalent combination of education and experience
Knowledge of global regulations for drug development is required.
Specialized knowledge in the development of mRNA, siRNA and Lipid Nanoparticle formulations is preferred.
A hands-on leader with a proven ability to participate in a high-performing team
Familiarity with GMP, GLP, and GCP is preferred.
Strong verbal and written communication skills
Excellent interpersonal skills: mature with a proven ability to work well with others throughout a diverse organization
Ability to work to manage deadlines and prioritize effectively, while maintaining flexibility
Additional Salary Information: Commensurate with qualifications and experience
Internal Number: 1240170
About Genevant Sciences
Genevant Sciences is a biopharmaceutical company focused on the discovery, development, and commercialization of a broad range of RNA-based therapeutics enabled by proprietary lipid nanoparticle (LNP) and ligand-conjugate delivery platforms. We are applying these technologies to develop innovative RNAi, mRNA, and gene-editing medicines to treat rare genetic disorders and other indications with significant unmet needs.