Career | <?phpecho $jobTitle;?> | <?phpecho $companyName;?>

Regulatory Affairs CMC Director/Sr. Director

RAPT Therapeutics

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Industry: Biotechnology
  • Post Date: 02/06/2023
  • Website: rapt.com
  • Company Address: 561 Eccles Avenue, South San Francisco, CA, 94080
  • Salary Range: $208,800 - $275,400

About RAPT Therapeutics

RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases.

Job Description

PURPOSE OF JOB:          

The Regulatory Affairs CMC Director/Senior Director is responsible for playing a vital role in progressing our drug candidates towards U.S. and international approval. The Director/Senior Director is a highly effective and collaborative leader, manager, and mentor, responsible for developing and executing innovative regulatory strategies in support of the chemistry, manufacturing, and controls (CMC) development with cross-functional team members in support of RAPT’s global development programs in inflammation and oncology. The successful candidate will provide direction to senior management and cross-functional teams, working in close partnership with Regulatory/CMC/Quality leadership, to shape the overall manufacturing strategy and achieve development milestones in a timely and compliant manner. The role requires a strong scientific background with understanding and experience in cGMP manufacturing, analytical development, and knowledge of relevant regulatory guidelines. 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. Ensure planning, coordination, and communication 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
  • Liase 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: 

  • Bachelor’s degree in a science, engineering, or related discipline
  • Advanced degree and/or Regulatory Affairs Certification (RAC) is a plus (e.g., PhD, MS in life science or MBA)

 

EXPERIENCE REQUIREMENTS: 

  • 7+ years Regulatory Affairs experience in the biopharmaceutical industry or equivalent
  • Extensive knowledge of cGMP, CMC regulatory requirements and early to late-stage experience with US, EU, international regulatory submissions in eCTD format; Expert knowledge of industry best practices and standards in Regulatory Affairs
  • Ability to lead matrixed teams, drive and influence effective collaborations
  • Strong scientific writing and oral communication skills with ability to summarize clearly and succinctly and tailor messaging to target audience
  • Demonstrated successful track record of interacting with global regulatory health authorities (face-to-face and other formal interactions) and effectively moving products through the development process
  • Experience with major submissions, including IND and NDA
  • Ability to interact effectively across all levels of the organizations; meet priorities and deadlines in alignment with corporate goals and objectives
  • Recognized as an influential leader who possesses a cross-functional collaborative skill set
  • Demonstrated proficiency in planning for department resources
  • Demonstrated ability to work both independently and in a team environment
  • Highly responsible, self-motivated professional with enthusiasm and passion for the work
  • Strong work ethic that with an appropriate sense of urgency and accuracy
  • Entrepreneurial orientation with the ability to effectively operate in a dynamic environment
  • Ability to problem-solve on complex issues, often in a cross-functional team setting
  • Prior experience managing direct reports, including coaching and career development
  • Excellent organizational skills that enable the successful execution of multiple simultaneous projects
  • Strong attention to detail and the ability to coordinate and oversee multiple activities

 

California law requires pay information in job postings. The specific rate will depend on the successful candidate’s qualifications, prior experience, and other relevant factors. The estimated annual pay range for this position is $208,800 (entry-level qualifications)  to $275,400 (highly experienced).

We use cookies to customize your user experience. Click “Agree” if you agree with our Policy.