Kelly Scientific is leading the search for a Regulatory Affairs Director – a permanent role with a pharmaceutical company focused on discovery and development of novel therapeutics to address unmet medical needs. This position will lead all regulatory activities, especially CMC aspects of new API and pharmaceutical product development.

Title: Regulatory Affairs Director
Location: Ballwin, MO
Salary: $145-160,000 + Benefits (Health/Dental/Vision insurance, performance-based bonus, etc.)

Key Responsibilities:

• Regulatory Strategy Development: Develop and implement regulatory strategies to support the development, approval, and lifecycle management of NDA and Innovation products, ensuring alignment with global regulatory requirements.
  

• Regulatory Submissions: Lead the preparation, review, and submission of regulatory application, including INDs, NDAs, BLAs, ANDAs, MAAs, and other global regulatory filings.
  

• Compliance: Ensure compliance with all relevant regulatory guidelines and standards, including ICH guidelines, FDA regulations, EMA requirements, and other global health authority expectations.
  

• Cross-Functional Collaboration: Work closely with R&D, manufacturing, quality, and other cross-functional teams to ensure that all CMC-related activities are aligned with regulatory requirements and timelines.
  

• Health Authority Interactions: Serve as the primary point of contact for regulatory interactions with global health authorities, including responding to inquiries, addressing deficiencies, and negotiating with regulatory bodies.
  

• Documentation and Reporting: Oversee the preparation and maintenance of high-quality regulatory documents, including CMC dossiers, technical reports, and responses to regulatory queries.
  

• Risk Management: Identify potential regulatory risks associated with CMC activities and develop strategies to mitigate these risks.
  

• Regulatory Intelligence: Stay abreast of changes in global CMC regulatory requirements and ensure that the company’s regulatory strategies are up to date and compliant with the latest guidelines.
  

• Team Leadership: Lead and develop a team of CMC regulatory professionals, providing guidance, mentoring, and performance management to ensure a high level of expertise and efficiency within the team.
  

• Training and Development: Provide training and support to internal teams on CMC regulatory requirements and best practices to ensure that all stakeholders are informed and compliant.

Qualifications:

• Education:  PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related field. Regulatory Affairs Certification (RAC) is a plus.
  

• Experience: Minimum of 15 years of experience in the pharmaceutical industry, with at least 5 years in a CMC regulatory role. Experience with both small molecules and biologics is preferred.
  

• Regulatory Expertise: Deep knowledge of global CMC regulatory requirements, including experience with INDs, NDAs, ANDAs, and other regulatory submissions.
  

• Technical Knowledge: Strong understanding of pharmaceutical development, manufacturing processes, analytical methods, and GMP compliance.
  

• Project Management: Proven ability to manage complex projects and timelines, with experience leading cross-functional teams to meet regulatory submission deadlines.
  

• Communication Skills: Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences.
  

• Problem-Solving: Strong analytical and problem-solving abilities, with a proactive approach to identifying and addressing regulatory challenges.
  

• Leadership: Demonstrated leadership experience, with a track record of building and leading high-performing regulatory teams.

Qualifications (Preferred):

• Experience in global regulatory submissions and interactions with health authorities, including the FDA, EMA, and other regulatory bodies.
  

• Experience with lifecycle management of pharmaceutical products, including post-approval changes and compliance.
  

• Familiarity with regulatory software and tools used in the preparation and submission of regulatory documents.
  

• Fluent in both English and Mandarin.

9640960