As part of the Global Regulatory Affairs Research and Development department (GRA R&D) you will be responsible for regulatory strategy and Health Authority liaison activities for development products. In this role you will be responsible for setting the GRA strategy for projects in the oncology and immuno-oncology portfolio, understanding the competitive environment and global regulatory landscape, ensuring alignment and ‘One Voice’ for GRA, and managing GRA staff, resources, and initiatives.
- Function as the Global Regulatory Lead and US/EU Lead for 1 or more development projects in the oncology portfolio
- Create an environment that attracts, develops, and maintains high quality employees
- Ensure consistent roles, responsibilities, and clear accountability for oncology staff aligned with the GRA operating model
- Manage direct reports (as assigned) responsible for regulatory strategy, submissions, and health authority liaison activities for the Company’s oncology portfolio from the initiation of development through to commercialization.
- Ensure adequate training and mentoring of direct reports
- Provide leadership to ensure sound regulatory strategies are in place to support development programs and to ensure functional alignment within the regulatory organization
- Lead, influence, and defend regulatory position with health authorities (HAs) and EMD Serono governance committees; act as a credible, influential, respected spokesperson during interactions with HAs and ensure proactive communication with agencies to expedient review and approval of submissions
- Ensure successful registration of development assets, exert influence through interactions with Health Authorities and contribute to shaping the regulatory environment for the portfolio
- Participate in governance committees, cross-functional and GRA initiatives; build partnership and optimize effective working relationships, shape or drive regulatory contribution and influence.
Who you are:
- Advanced degree and minimally 10 years of relevant regulatory experience
- At least 5 years of recent oncology experience leading and managing teams
- Experienced strategist with a record of successful FDA interactions supporting significant submissions, including original NDAs/BLAs, efficacy supplements
- Skilled at attracting, developing, and maintaining talent
- Willingness to travel both domestically and internationally
- Demonstrated Leadership capabilities
- Excellent written and spoken communication skills
- Good interpersonal skills
- Attention to detail
- Ability to work in teams
- Strong organizational and planning skills
To Apply: https://www.jobg8.com/Traffic.aspx?XTDwhfY%2blvEZUHB0OpUjOww