Hybrid Associate Director, CMC Regulatory Affairs – Hematology/Oncology

at Regeneron

• Job title: Associate Director, CMC Regulatory Affairs – Hematology/Oncology
• Job type: Full Time
• Experience level: Senior
• Salary: $157,200 - $256,600 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Tarrytown, United States

About the role

• Associate Director leading CMC regulatory strategies for hematology and oncology portfolios. Mentoring staff and guiding regulatory activities while collaborating with cross-functional teams.

Responsibilities

• lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios
• guide regulatory activities across development stages, mentor CMC Regulatory Affairs staff, supporting cross-functional and external partners, and serving as a key liaison in regulatory authority interactions
• lead product development activities from a CMC regulatory standpoint with input from senior management
• represent CMC RA at program meetings and independently provide regulatory interpretation, position, and covering clinical development, initial market applications, and approval/post-approval activities
• identify program issues and develop appropriate regulatory strategies to mitigate risks to filings
• critically review and provide meaningful and strategic input on regulatory filing documents to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics
• lead and facilitate interactions with global regulatory authorities
• perform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings
• mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management
• develop and create working instructions, SOPs, and/or templates to facilitate consistent and efficient practice across the CMC RA groups
• identify gaps in the IOPS and global RA processes, bring up to higher management, and help to improve business efficiency
• support establishing, managing, and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field
• manage and coach team member(s)

Requirements

• a bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including 5+ years of relevant CMC experience
• an advanced degree is preferred
• proven track record supporting small molecule drugs and/or biological products through development and approval
• experience in 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)