About this role
Role Overview
- lead the development and execution of global CMC regulatory strategies for the Obesity portfolio
- guide regulatory activities across development stages
- mentor CMC Regulatory Affairs staff
- support cross-functional and external partners
- serve as a key liaison in regulatory authority interactions
- lead product development activities from a CMC regulatory standpoint
- represent CMC RA at program meetings
- identify program issues and develop regulatory strategies to mitigate risks
- critically review and provide input on regulatory filing documents
- facilitate interactions with global regulatory authorities
- perform final review and approval of compliance activities
- develop working instructions, SOPs, and/or templates
- identify gaps in IOPS and global RA processes
Requirements
- bachelor's degree with a minimum of 10 years of pharmaceutical/biotech industry experience
- 5+ years of relevant CMC experience
- proven track record supporting small molecule drugs and/or biological products through development and approval
- good understanding of current CMC worldwide regulations and guidelines
- experience interacting with the US FDA and other regulatory authorities
- experience with device regulatory requirements and development processes for combination products is a plus
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)