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The Senior 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 progresses 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
- Ensure that documents to be submitted to the health authorities are compliant with eCTD submission requirements.
- Format documents per Kite Style
- 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
- BA/BS and 8 years, MA/MS and 6 years, or PhD/PharmD and 3 years of relevant US regulatory (FDA) / drug development experience
- Good communication skills – both oral and written
- Organizational skills – detail oriented and can deal with frequent changes in product activity
- Strong knowledge of eCTD elements and structure
- Strong team player that has a customer service approach and is solution oriented
- Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- High level of proficiency in relevant software (i.e., MS Word, MS Office or similar systems, Adobe)
- Expertise with templates and formatting tools
- High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
- Willingness to think outside of the box and adapt best practices to our small, but growing environment
- Ability to adapt in a constantly evolving environment
- Self-motivated with a strong sense of ownership in areas of responsibility
- High degree of professionalism, ethics and integrity
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities