Director, Regulatory CMC

Position Summary 

The Director, Regulatory CMC will lead our Chemistry, Manufacturing, and Controls (CMC) regulatory affairs.  This position is vital for ensuring that our CMC submissions meet regulatory requirements and align with our overall business strategy. The position will report directly to the Chief Technology Officer with a dotted line to the Executive Director, Global Regulatory Affairs. The ideal candidate will have extensive experience in CMC regulatory affairs, particularly in writing CMC sections for INDs, NDAs, BLAs, and MAAs, as well as leading teams. 

Responsibilities 

• Regulatory Strategy and Leadership: 
  • Develop and implement regulatory strategies for CMC submissions, ensuring alignment with FDA, EMA, and other global regulatory requirements. 
  • Provide strategic guidance to cross-functional teams, including R&D, manufacturing, and quality, to ensure CMC compliance throughout the product lifecycle.
  • Work with internal Quality to develop CMC regulatory strategies to navigate the change throughout the molecule development cycles, including but not limited to manufacturing site changes, process improvements, and market expansions. 

• CMC Submissions and Compliance:
  • Oversee the preparation, review, and submission of CMC regulatory documentation, including detailed CMC sections for INDs (Investigational New Drug Applications), NDAs (New Drug Applications), BLAs (Biologics License Applications), and MAAs (Marketing Authorization Applications).  
  • Ensure that CMC submissions are complete, accurate, and meet all regulatory requirements, including data integrity, quality standards, and regulatory guidelines.
  • Manage interactions with regulatory agencies, addressing queries, providing responses, and ensuring timely resolution of any issues related to CMC. 

• Writing and Documentation:
  • Lead the development and writing of CMC sections for regulatory submissions, ensuring that all content is scientifically accurate, regulatory compliant, and clearly communicates product development, manufacturing processes, and quality control measures.
  • Ensure that CMC documentation supports the overall regulatory strategy and meets the expectations of regulatory authorities in major markets.
  • Review and edit CMC sections prepared by internal teams or external partners to ensure consistency, accuracy, and compliance. 

• Cross-Functional Collaboration:
  • Collaborate with internal teams, including R&D, manufacturing, quality assurance, and legal, to integrate regulatory requirements into product development and manufacturing processes.
  • Provide regulatory input on product development plans, manufacturing changes, and quality control processes to ensure compliance and mitigate regulatory risks. 

• Regulatory Strategy and Policy Development:
  • Monitor and interpret changes in global regulatory requirements related to CMC and advise on their impact on ongoing and future projects.
  • Develop and implement internal policies and procedures to ensure compliance with regulatory requirements and industry best practices. 

• Risk Management and Problem Resolution:
  • Identify and assess potential regulatory risks related to CMC and develop strategies to mitigate these risks.
  • Lead investigations into regulatory compliance issues or deviations, providing actionable solutions and corrective actions as necessary. 

• External Engagement:
  • Represent the company in interactions with regulatory agencies, industry groups, and other external stakeholders on CMC-related matters.
  • Stay informed about industry trends and regulatory developments, applying this knowledge to enhance the company's regulatory strategies and practices. 

Qualifications 

• B.S./B.A. required; advanced degree preferred (M.S., Ph.D., PharmD or equivalent) in a relevant scientific discipline. 

• Minimum of 10 years of experience in regulatory affairs with a strong focus on Chemistry, Manufacturing, and Controls (CMC). 

• Proven track record of managing CMC regulatory submissions and interactions with regulatory agencies in a pharmaceutical, biotech, or medical device environment. 

• Extensive experience in writing and preparing CMC sections for INDs, NDAs, BLAs, and MAAs, demonstrating thorough understanding of regulatory expectations and requirements. 

• Demonstrated ability to manage complex regulatory projects and lead cross-functional teams. 

• Deep knowledge of FDA, EMA, and other international regulatory requirements and guidelines related to CMC. 

• Strong leadership and management skills, with a demonstrated ability to build and lead high-performing teams. 

• Excellent analytical and problem-solving abilities, with a strategic approach to addressing regulatory challenges. 

• Exceptional communication and interpersonal skills, with the capacity to influence and collaborate effectively with internal and external stakeholders. 

• Ability to manage multiple projects and priorities simultaneously in a fast-paced, dynamic environment. 

Salary Range:  

$180,000 - $230,000 

About Angitia 

Established in June 2018, Angitia Biopharmaceuticals is a multinational research and development enterprise focusing on discovery and development of new drugs for grievous bone, muscle, and joint diseases. Our mission is to discover, develop and commercialize breakthrough therapeutics that address the key unmet medical needs of serious musculoskeletal diseases. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development, and management from both overseas and domestic large multinational companies. The company has built an organization distinguished by world-class scientists with talents that are proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines. The company is committed to serving patients in need by carrying out innovative science including internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking talented individuals who are innovative, ambitious, and great team players to join our vibrant group. 
 

Benefits: 

• Medical, dental, and vision coverage for employees and their eligible dependents 

• 401(K) Retirement Plan with partial Company match 

• Company paid Long Term Disability Coverage 

• Company-paid life Insurance & AD&D Coverage 

• Voluntary Life Insurance & AD&D Coverage 

• Employee Assistance Program (EAP) 

• Company-paid Holidays 

• Paid Time Off 

• Paid Sick Leave 

• Telecommunication Monthly Stipend 

• Work-From-Home Equipment Reimbursement