If you’re a high-energy, ambitious leader in a regulatory profession with program management background, we want to speak with you. At Roche, we keep it simple – we are doing now what patients need next!
REGULATORY ASSOCIATE PROGRAM DIRECTOR
Department: PD Regulatory Program Management (PD)
Location: Mississauga Campus
In this key strategic role within the I2ON (immunology, infectious disease, ophthalmology, neuroscience) Regulatory Program Management team you will interpret the needs of worldwide health authorities while providing the regulatory expertise to drive product development from early development to post-marketing. You will take the lead for assigned projects and represent PDR to cross-functional teams and groups and serve as the principal interface with health authorities, managing the strategies for and execution of these interactions.
- Plays a key role in creating innovative long-range strategies to expedite development of our projects in immunology, infectious disease, ophthalmology, or neuroscience therapeutic areas from entry into man through lifecycle management.
- Develops regulatory strategies with global cross functional clinical, non-clinical and business development teams. Provides project teams with leadership regarding regulatory authority interactions.
- As the US regulatory subject matter expert, leads the US Regulatory strategy as a member of a global Regulatory Affairs Functional Team (RAFT) for assigned development projects. Serves as the primary regulatory representative on one or more regional or global projects at any one point in time.
- Acts as primary liaison and manages a professional relationship between the FDA and project teams for assigned projects.
- Responsible for on time and quality regulatory submissions for INDs and BLAs/NDAs to the FDA.
- Collaborates with the Canadian regulatory affiliate to develop and manage regulatory strategy and submissions to Health Canada for assigned projects.
- Briefs regulatory management
- Mentors and coaches junior regulatory professionals.
- Stays abreast of internal and external developments, trends and other dynamics relevant to the work of Product Development and Regulatory to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects.
- Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.
- Bachelors Degree required (life sciences disciplines strongly preferred)
- Average of 5 or more years’ relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing. Experience participating in global product development teams is preferred
- Experience as a regulatory contributor for global original IND/NDA/BLA filings in the US is preferred.
- Broad understanding of US FDA regulations, processes and issues in drug/biologics development. Includes in-depth knowledge of GCP (Good Clinical Practice) and ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use).
- Previous experience working in a matrix management environment.
- Background in neuroscience or rare diseases is preferred but not mandatory
Qualified candidates are encouraged to submit cover letter and resume no later than January 8, 2020.
Please note that the interviews will take place in 2020.
Please note that this role could be offered at different levels, commensurate with candidates experience (Associate Director or Program Manager level)
This position is not eligible for relocation support.
This position is open to applicants legally authorized to work in Canada.
NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including educational, employment, references and criminal records (for which a pardon has not been granted) checks.
Roche is an equal opportunity employer and prohibits unlawful discrimination based upon any legally protected ground. Roche will make a good faith effort to accommodate the individual needs of applicants with disabilities in our recruitment process