Sr. Manager, Regulatory Affairs
SciPro Global are currently working with one of our key clients, a biopharmaceutical company who is actively engaged in the development of innovative cancer immunotherapies, based in California. Together, we are looking for a Manager/ Sr. Manager Regulatory Affairs to join their growing Regulatory Affairs team. As the Sr. Manager, Regulatory Affairs will be able to work in a matrix environment and possess the credentials to be the US lead in providing both strategic input and day to day guidance for the projects assigned.
Responsibilities (include but are not limited to):
- Provide regulatory guidance to cross-functional teams ensuring the project assigned progress from IND stage to launch within company agreed timelines.
- Ensure regulatory compliance with relevant regulations and effectively managing timely submissions to the appropriate regulatory authorities
- Manage the preparation of applications and subsequent regulatory documents, pre and post approval in accordance with agreed timeframes
- Ensure submission-readiness of all regulatory documents related to the project and ensure the documents submitted to the health authorities are compliant with eCTD submission requirements.
- Assist in developing junior regulatory affairs staff.
- Determine risk assessment and implement regulatory strategies for products in pre and post-approval stages.
- Build long-term effective relationships and open communication with cross-functional teams in order to provide accurate information and timeframes.
- Participate in R&D meetings to discuss project issues and develop priorities to produce clear project plans.
- Participate in inter-departmental meetings to discuss project issues and priorities and develop clear plans to achieve the required goals.
- Develop and maintain a positive working rapport with the regulatory agencies
- Develop and maintain standard operating procedures or local working practices
- Maintain current knowledge of relevant regulations, including proposed and final rules
- Basic Qualifications: Bachelor's degree as well as 3-7 years of relevant US regulatory experience
- Strong knowledge of eCTD elements and structure
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- High level of proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities
If this is something you would be interested in, or know someone who might be, please get in touch at your earliest convenience; firstname.lastname@example.org