Job Description
About the Role
We are seeking an Associate Director of Regulatory Affairs to support the development and execution of regulatory strategies across our clinical programs. This individual will play a hands on role in health authority interactions, submission planning, and cross functional program support, working closely with Clinical Development, CMC, Quality, and senior regulatory leadership. This is a high visibility role for someone ready to take on greater strategic ownership while staying close to the execution that drives programs forward
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Key Responsibiliti
- esSupport the development and execution of US and global regulatory strategies for assigned progra
- msLead or co lead the preparation of regulatory submissions including INDs, CTAs, amendments, annual reports, and briefing documen
- tsPrepare for and participate in health authority interactions, including meeting request packages, briefing books, and rehearsa
- lsServe as the regulatory representative on cross functional program teams, providing day to day guidance on regulatory requirements and timelin
- esAssess regulatory implications of protocol designs, CMC changes, and nonclinical plans, and communicate risks and options to the te
- amMonitor FDA and ICH guidance, regulatory precedents, and competitor activity relevant to assigned progra
- msManage timelines and deliverables with regulatory operations, medical writing, and external vendors to ensure on time, high quality submissio
- nsSupport evaluation of expedited pathway opportunities such as Fast Track, Breakthrough Therapy, and Orphan Drug designatio
- nsContribute to SOPs, regulatory processes, and departmental initiatives as the function scal
es
Qualificati
- onsBachelor's degree in a life sciences discipline required, advanced degree (MS, PharmD, PhD) preferred, RAC a p
- lus8 to 10 years of regulatory affairs experience in the biotechnology or pharmaceutical indus
- tryDirect experience preparing and filing INDs and supporting health authority meetings, FDA experience required, EMA exposure a p
- lusStrong working knowledge of FDA regulations and ICH guidelines across clinical developm
- entExperience working on cross functional development teams in a sponsor environm
- entExcellent written and verbal communication skills with the ability to distill complex regulatory issues into clear recommendati
- onsComfortable in a fast paced, lean environment where ownership and adaptability mat
ter