Associate Director, CMC Regulatory Affairs

Role Summary

Associate Director, CMC Regulatory Affairs in Danbury, CT. Leads and compiles global regulatory submissions using eCTD, oversees responses to deficiency comments from health authorities, and develops regulatory documents and strategy related to expedited programs and internal change controls.

Responsibilities

• Lead and compile global regulatory submissions using eCTD.
• Oversee preparation of responses to deficiency comments/letters from health authorities; provide input on interpretation and formulate responses.
• Assist with development of documents submitted to health authorities related to expedited regulatory programs, meeting requests, and background packages.
• Author internal regulatory documents, such as Regulatory Assessments and Strategy documents.
• Review internal change controls and assess impact to regulatory filings.

Qualifications

• Required: Pharm.D or Ph.D. in Regulatory Affairs, Life Sciences, or related field, or foreign equivalent.
• Required: 5 years of experience in the offered position or related role.
• Required: At least 5 years of experience with analysis and interpretation of complex problems and data in regulatory affairs.
• Required: At least 5 years of experience with global regulatory guidelines (U.S., LATAM, EMEA, APAC) and other regulations/requirements.
• Required: At least 5 years of experience with small molecule/biologics.

Skills

• Regulatory submissions and strategy development
• Regulatory health authority communications
• Document authoring for regulatory submissions
• Change control impact assessment
• Global regulatory knowledge across regions

Education

• Pharm.D or Ph.D. in Regulatory Affairs, Life Sciences, or related field (or foreign equivalent).

Additional Requirements

• None specified beyond qualifications.