Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

About the role

You will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, support cross-functional and external partners, and serve as a key liaison in regulatory authority interactions.

Responsibilities

• 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 cover clinical development, initial market applications, and approval/post-approval activities.
• Identify program issues and develop appropriate regulatory strategies to mitigate risks to filings, independently find alternative solutions/work-arounds, and obtain consensus.
• Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
• Lead and facilitate interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).
• 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 in accordance with country-specific regulatory guidance documents.
• Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks.
• 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.
• Find opportunities to initiate operational changes and policy modifications.
• Manage and coach team members.

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 biological products through development and approval.
• A strong grasp of CMC worldwide regulations and guidelines.
• 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.

Qualifications

• A strong grasp of CMC worldwide regulations and guidelines.
• 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.

Skills

• Strong grasp of CMC worldwide regulations and guidelines.
• 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

• Comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

• $157,200.00 - $256,600.00 annually

Schedule

• For US locations, this role is on-site 4 days in the office and 1 day from home.
• For Uxbridge, UK or Dublin, Ireland this role would be on-site 3 days per week and 2 days from home.
• A fully remote role is not possible for this position.