Senior Director, Regulatory Affairs CMC

Job Description

Job Description

Salary : $278,000 - $297,300

PURPOSE OF JOB :

The Senior Director, Regulatory Affairs CMC is responsible for progressing our therapeutic candidates towards U.S. and global approvals. The Senior Director is a highly effective and collaborative leader, manager, and mentor, responsible for developing and executing innovative regulatory strategies in support of chemistry, manufacturing, and controls (CMC) development with cross-functional team members in support of RAPTs global development programs to treat patients with inflammatory and immunologic diseases. They will provide direction to senior management and cross-functional teams, work in close partnership with Regulatory / CMC / Quality leadership, to shape the overall manufacturing strategy and achieve development milestones in a timely and compliant manner. This role can be remote in the U.S. or at the South San Francisco location.

MAJOR DUTIES AND RESPONSIBILITIES :

• Lead and manage all aspects of CMC regulatory strategy development (early- to late- stage / registration / post -market)
• Integrate CMC plans with overall development plans. Plan, coordinate, and communicate to develop timely and robust regulatory strategies and submissions to meet overall program objectives / milestones
• Lead teams in examining regulatory strategy options, provide relevant regulatory guidance
• Provide regulatory leadership and guidance to senior management and cross-functional project teams, including external contractors, vendors, and consultants, to design and implement high quality regulatory strategies
• Identify and assess regulatory risks and critical-path activities associated with CMC development programs and work to identify regulatory strategies to mitigate risks
• Monitor and analyze regulatory agency activities regarding CMC development and assess potential impact on development programs and understand the regulatory landscape
• Evaluate proposed manufacturing changes for global impact and provide strategic regulatory strategies that support compliant change implementation
• Serve as CMC Regulatory Lead on cross functional project teams to achieve project milestones / goals
• Serve as the Regulatory point of contact for Contract Manufacturing Organizations and Qualified Persons
• Liaise directly with FDA, and other global regulatory health authorities, as appropriate
• Prepare and lead teams through successful regulatory meetings and interactions with global regulatory health authorities
• Lead global CMC regulatory submission development. Responsible for planning, coordinating, and developing high quality, compliant and timely CMC (Quality) regulatory submissions according to current regulatory requirements and guidance to obtain efficient and timely regulatory approvals (IND / IMPD, NDA / MAA, pre-meeting briefing packages, etc.)
• Participate in the recruitment, performance, and management of staff in Regulatory Affairs, including coaching, career development and oversight of work, as required
• Lead assigned department initiatives and seek opportunities to foster interdepartmental collaboration
• Develop processes and infrastructure that support program needs, including but not limited to SOP development
• Build positive professional relationships and trust with team members, colleagues, external contractors, vendors, consultants, and regulatory authority contacts

EDUCATION REQUIREMENTS :

EXPERIENCE REQUIREMENTS :