Director of Regulatory Affair

Humanwell Pharmaceutical US, Inc. is a St. Louis, MO-based pharmaceutical company focused on discovery and development of novel therapeutics to address unmet medical needs. At Humanwell, we work towards improving patients' quality of life and are committed to creating a healthier world of tomorrow. We are looking for people who are passionate about making people’s lives better.With Humanwell US’s recent expansion, we are actively seeking a Regulatory Affairs Director to lead and manage all regulatory activities including the Chemistry, Manufacturing, and Controls (CMC) aspects of new API and pharmaceutical product development. This role encompasses the planning, authoring, compiling, reviewing, and timely submission of high-quality regulatory documentation to the FDA, ensuring adherence to company timelines and strict regulatory guidelines. The Director will collaborate closely with drug discovery, formulation, CMC, preclinical and clinical teams and external regulatory collaborators to ensure that all CMC regulatory submissions—including Pre-INDs, INDs, NDAs, ANDAs, amendments, correspondence, annual reports, and other essential regulatory filings—meet the standards of global health authorities. This position is critical in supporting the development and approval of new active pharmaceutical ingredients and pharmaceutical products. The ideal candidate will have a strong background in CMC and regulatory affairs, with extensive experience in regulatory submissions and compliance.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.Preferred Qualifications:

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 Chinese.Compensation:

Competitive salary and performance-based bonuses.Comprehensive benefits package, including health, dental, vision, and retirement plans.Opportunities for professional growth and advancement within the company.Humanwell Pharmaceuticals US

is an equal-opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.#J-18808-Ljbffr